[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"anatomic-stage-ii-breast-cancer-ajcc-v8\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:anatomic-stage-ii-breast-cancer-ajcc-v8":607},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,46,0,25,[9,44,64,91,103,123,133,153,175,196,217,236,257,280,299,326,347,366,388,500,516,534,550,568,588],{"id":10,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100053526",false,"NCT07391774","Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial","A Phase III Trial of Rx Therapy Guided by Genomic Risk Assessment for High Anatomic Stage ER-pos\u002FHER2-neg Breast Cancer With RS≤25 (RxFINE-Low)","Inclusion Criteria:\n\n* STEP 0: Patient must be ≥ 18 years of age\n* STEP 0: Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 28 days prior to Step 0 pre-registration\n* STEP 0: Patient must be a postmenopausal woman or a man\n\n  * NOTE: Menopause can be determined by any of the following:\n\n    * Prior bilateral oophorectomy\n    * Age ≥ 60 years\n    * Age \\\u003C 60 years with amenorrhea for ≥ 12 months and estradiol and follicle stimulating hormone (FSH) levels in the postmenopausal range\n  * NOTE: FSH and estradiol levels should be repeated as clinically indicated to ensure menopausal status in patients with breast cancer with chemotherapy-induced amenorrhea\n* STEP 0: Patient must meet one of the following staging criteria postoperatively according to American Joint Committee on Cancer (AJCC) 8th edition criteria\n\n  * pT0-T3 with 3 positive ipsilateral lymph nodes (micro-or macrometastatic disease) and no planned axillary lymph node dissection after definitive surgery in the breast and axilla with curative intent.\n  * pT0-T3 with N2 or N3\n  * pT3 with N0-N3\n\n    * NOTES:\n\n      * Patients with T4 breast cancer are not eligible.\n      * Positive isolated tumor cells (ITCs) in axillary nodes without micro- or macrometastasis are considered N0 for eligibility purposes.\n      * ITC does not contribute to nodal count for staging purposes\n* STEP 0: Patient must have a primary breast tumor that is estrogen receptor (ER) positive with \\> 10% ER expression by immunohistochemistry (IHC) as per 2020 American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) Estrogen Receptor Testing Guideline.\n\n  * NOTE: ER 1-10% are reported as ER low positive. These tumors have less endocrine-sensitive disease and are not eligible)\n* STEP 0: Patient must have a primary breast tumor that is HER2-negative by current ASCO\u002FCAP guidelines utilizing immunohistochemistry and\u002For fluorescence in situ hybridization (FISH)\n* STEP 0: Patient may have multicentric or multifocal breast cancer if the highest stage tumor meets eligibility criteria outlined above, and the tumor sites are felt to represent a single disease process by local pathology or other sites of disease are also ER-positive (\\> 10%) and HER2 negative, if such testing is completed. If local pathology feels that multicentric or multifocal disease may represent distinct disease processes repeat disease receptor testing is required other sites of disease must also be also ER-positive (\\> 10%) and HER2-negative\n* STEP 0: For patients who have undergone a lumpectomy, the margins of the resected specimen or re-excision must be histologically free of invasive tumor and ductal carcinoma in situ (DCIS) as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional excisions may be performed to obtain clear margins. Positive posterior margin is allowed if surgeon deems no further resection possible. Patients with margins positive for lobular carcinoma in situ (LCIS) are eligible without additional resection\n* STEP 0: For patients who have undergone mastectomy, the margins must be free of residual gross tumor. Patients with microscopic positive margins are eligible if post-mastectomy radiation treatment (RT) of the chest wall will be administered\n* STEP 0: Patient must have undergone axillary staging with sentinel lymph node biopsy (SLNB), targeted axillary dissection (TAD), or axillary lymph node dissection (ALND)\n* STEP 0: Patient must have no evidence of locoregional or distant metastatic disease by clinical history and physical exam. Treating physician can consider additional imaging evaluation per National Comprehensive Cancer Network (NCCN) guidelines and\u002For institutional practice\n* STEP 0: Patient must be able to have Oncotype DX testing performed.\n\n  * If Oncotype DX testing was previously performed, the results of Recurrence Score (RS) must be available and must meet Step 1 eligibility criteria.\n  * If Oncotype DX testing was not performed yet, tissue from the core, excisional biopsy or surgical specimen of the tumor lesion must be available and must be shipped to Exact Sciences for determination of the Oncotype DX Recurrence Score (RS) for eligibility and stratification.\n\n    * NOTE: Exact Sciences will notify the submitting institution of Recurrence Score results within two (2) weeks of receipt of the tumor specimen. Institutions will receive an email notification of eligibility status once Recurrence Score results are entered into Rave by the submitting institution\n* STEP 0: Patient must have had their final cancer surgery for breast cancer (including re-excision of margins) less than 16 weeks prior to Step 0 Pre-Registration.\n\n  * NOTE: This excludes additional surgery for reconstructive purposes\n* STEP 0: Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* STEP 0: Patients with synchronous DCIS or LCIS are eligible\n* STEP 0: Patient with prior history of ER-negative DCIS diagnosed at least 5 years prior to Step 0 Pre-Registration without evidence of recurrence are eligible\n* STEP 0: Patient must not have a prior history of invasive ER-positive breast cancer. Patients with a history of ER-negative breast cancer are eligible if they were diagnosed at least 5 years prior to Step 0 Pre-Registration and have had no evidence of recurrence\n* STEP 0: Patients must not have received prior endocrine therapy such as tamoxifen, raloxifene, or aromatase inhibitors for chemoprevention within 5 years prior to Step 0 Pre-Registration with the exception of a short course of endocrine therapy of less than 6 weeks duration prior to Step 0 Pre-Registration.\n\n  * NOTE: The Oncotype Dx for study eligibility must be performed on specimen obtained prior to initiation of any endocrine therapy\n* STEP 0: Patient must not be concurrently using systemic hormone replacement therapy (HRT). If receiving HRT at the time of breast cancer diagnosis, this must be discontinued prior to Step 0 Pre-Registration with appropriate washout\n* STEP 0: Absolute neutrophil count (ANC) ≥ 1,500\u002FµL (obtained ≤ 28 days prior to Step 0 Pre-Registration)\n* STEP 0: Hemoglobin ≥ 9.0 g\u002FdL (obtained ≤ 28 days prior to Step 0 Pre-Registration)\n* STEP 0: Platelets ≥ 100,000\u002FµL (obtained ≤ 28 days prior to Step 0 Pre-Registration)\n* STEP 0: Total bilirubin ≤ institutional upper limit of normal (ULN) or \\\u003C 1.5 x ULN for patients who have a bilirubin elevation in patients with well documented Gilbert's disease or similar syndrome involving slow conjugation of bilirubin (obtained ≤ 28 days prior to Step 0 Pre-Registration)\n* STEP 0: Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 2.5 × institutional ULN (obtained ≤ 28 days prior to Step 0 Pre-Registration)\n* STEP 0: Estimated glomerular filtration rate (eGFR) ≥ 30 mL\u002Fminute\u002F1.73 m\\^2 (obtained ≤ 28 days prior to Step 0 Pre-Registration)\n* STEP 0: Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of Step 0 Pre-Registration are eligible for this trial\n* STEP 0: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* STEP 0: Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* STEP 0: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2 or better\n* STEP 0: Patient must have a standard 12-lead electrocardiogram (ECG) within 28 days prior to Step 0 Pre-Registration, documenting:\n\n  * QT interval using Fridericia's correction (QTcF) \\\u003C 450 msec.\n  * Resting heart rate 50-90 beats per minute (determined from the ECG)\n* STEP 0: Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and\u002For family member available will also be considered eligible\n* STEP 0: Patient must not have comorbidities considered a safety risk for standard adjuvant chemotherapy, endocrine therapy or CDK4\u002F6 inhibitor as per Investigator's discretion\n* STEP 0: Patient must not have a contraindication to adjuvant chemotherapy based on treating physician's discretion\n* STEP 0: Patient must not have received prior chemotherapy for this malignancy\n* STEP 0: Patient must not have received prior CDK4\u002F6 inhibitor\n* STEP 0: Patient must not have a known contraindication to ribociclib per current Food and Drug Administration (FDA) indication\n* STEP 0: Patient must not have a known hypersensitivity to any of the excipients of ribociclib and\u002For endocrine therapy (ET) (e.g. rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, glucose-galactose malabsorption, and soy allergy)\n* STEP 0: Males must not expect to father children and males and their partners must be willing to use highly effective methods of contraception while on protocol treatment. Males must not donate sperm while on protocol treatment and for at least 12 weeks following the last dose of protocol treatment.\n\nHighly effective methods include the following:\n\n* Intrauterine device\n* Bilateral tubal occlusion\n* Vasectomized partner\n* Sexual abstinence If the highly effective contraceptive methods are contraindicated or strictly declined by the patient, or in the event of sexual activity of low frequency, a combination of male condom with cap, diaphragm, or sponge with spermicide (double-barrier methods) is also considered an acceptable birth control method. Local regulation\u002Fguidelines are to be followed with regard to highly effective birth control method, if more restrictive\n\n  * STEP 1: Patient must meet all Step 0 Pre-Registration eligibility criteria at the time of their Step 1 randomization\n  * STEP 1: Patient must not have had any major surgery or radiotherapy within 14 days prior to Step 1 randomization\n  * STEP 1: Patient must have a Recurrence Score (RS) of 0-25 from Oncotype DX testing from diagnostic biopsy or surgical specimen as reported by the Exact Sciences assay","ALL","18 Years",{"count":19,"type":20},1978,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","This phase III trial compares standard of care hormone therapy plus ribociclib to chemotherapy followed by hormone therapy plus ribociclib for the treatment of patients with high anatomic stage breast cancer with low risk of the cancer returning (low risk recurrence). Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Hormone therapy, with letrozole, anastrozole or exemestane, lowers the amount of estrogen made by the body. This may help stop the growth of tumor cells that need estrogen to grow. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Hormone therapy plus ribociclib may work as well as chemotherapy followed by hormone therapy plus ribociclib for the treatment of high anatomic stage breast cancer with low recurrence risk.",[26,27,28,29,30],"Anatomic Stage II Breast Cancer AJCC v8","Anatomic Stage IIIA Breast Cancer AJCC v8","Anatomic Stage IIIC Breast Cancer AJCC v8","Estrogen Receptor-Positive Breast Carcinoma","HER2-Negative Breast Carcinoma","RECRUITING","2026-07-10",{"date":34,"type":35},"2026-07-13","ACTUAL",{"date":37,"type":20},"2027-02-14",{"date":39,"type":20},"2029-07-31",{"name":41,"class":42},"National Cancer Institute (NCI)","NIH",59,{"id":45,"slug":4,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":57,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":63},"100053294","NCT06058377","Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxel, Cyclophosphamide, and Doxorubicin) for Stage II-III Breast Cancer","Phase III Trial Of Neoadjuvant Durvalumab (NSC 778709) Plus Chemotherapy Versus Chemotherapy Alone For Adults With MammaPrint High 2 Risk (MP2) Hormone Receptor (HR) Positive \u002F Human Epidermal Growth Factor Receptor (HER2) Negative Stage II-III Breast Cancer","Inclusion Criteria:\n\n* STEP 1: REGISTRATION (SCREENING): Participants must have histologically confirmed estrogen receptor (ER) positive and\u002For progesterone receptor (PR) positive (hormone receptor positive) and HER2 negative breast cancer, as per American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines\n\n  * NOTE: Participants with HER2 positive disease by ASCO CAP guidelines are ineligible. HER2 negative and HER2 low or equivocal cases as per ASCO CAP guidelines that do not receive HER2 targeted therapy are eligible\n* STEP 1: REGISTRATION (SCREENING): Participants must have clinical stage II or III breast cancer\n\n  * NOTE: Participants with inflammatory breast cancer are eligible\n  * NOTE: Participants with occult (i.e. undetectable) primary breast cancer with axillary nodal involvement are not eligible, as MammaPrint testing has not been validated on tissue obtained from an axillary lymph node\n* STEP 1: REGISTRATION (SCREENING): Participants must not have metastatic disease (i.e., must be clinically M0 or Mx) Systemic staging studies with imaging should follow routine practice as per National Comprehensive Cancer Network (NCCN) and ASCO guidelines\n* STEP 1: REGISTRATION (SCREENING): Participants must not have locally recurrent breast cancer\n* STEP 1: REGISTRATION (SCREENING): Participants with multifocal disease in the same breast or synchronous bilateral primary tumors are eligible, however, all tumors that are biopsied must be hormone receptor positive and HER2 negative per ASCO CAP guidelines and at least one of the tumors must be MammaPrint High-2. MammaPrint can be performed sequentially on biopsies as it is sufficient to have MammaPrint High 2 status on at least one of the lesions\n\n  * NOTE: Biopsy of multiple lesions in the same breast is not required if the clinical presentation is consistent with a single disease process that is multifocal in nature. However, if there is clinical suspicion of two distinct primary breast malignancies, additional biopsies should be pursued\n* STEP 1: REGISTRATION (SCREENING): Participants must have either adequate tissue available to submit on-study or a prior known MammaPrint Index Score that is MP2 status\n\n  * Submitting tissue for on-study MammaPrint testing:\n\n    * Participants must have a minimum of ten, unstained formalin-fixed paraffin-embedded (FFPE) slides (4-5 micron thickness) available from initial tumor biopsy for MammaPrint assessment\n\n      * NOTE: Participants must agree to have this tissue submitted to Agendia for MammaPrint Index Scoring and to have subsequent results disclosed to Southwest Oncology Group (SWOG) Cancer Research Network OR\n  * Submitting prior known MammaPrint Index Score:\n\n    * If a MammaPrint Index Score report from within the last 12 weeks is already known and is MP2 status, the participant must be registered to Step 2 immediately following Step 1 registration provided they meet all other criteria. MP2 status is defined as a MammaPrint Index score between negative 1.0 and negative 0.57 (-1.0 to -0.57, including negative 1.0 and negative 0.57) tested from initial tumor biopsy\n\n      * NOTE: Participants must agree to have their commercial MammaPrint Index Score disclosed to SWOG Cancer Research Network\n      * NOTE: Participants with prior known MammaPrint result that is not MP2 status should not be enrolled to either step of this study\n      * NOTE: Participants enrolling with known MP2 status (i.e. MP already obtained as routine care) must only sign the treatment informed consent form. Screening consent is not required when MP2 status is known prior to study enrollment\n* STEP 1: REGISTRATION (SCREENING): Participants must not have received any prior treatment for their current breast cancer, including chemotherapy, immunotherapy, biologic or hormonal therapy, and must be candidates for doxorubicin, paclitaxel, and durvalumab therapy\n* STEP 1: REGISTRATION (SCREENING): Participants must be \\>= 18 years old at the time of registration\n* STEP 1: REGISTRATION (SCREENING): Participants must have body weight \\> 30 kg\n* STEP 1: REGISTRATION (SCREENING): Participants must have Zubrod Performance Status of 0-2\n* STEP 1: REGISTRATION (SCREENING): Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* STEP 1: REGISTRATION (SCREENING): Participant must not have medical contraindications to receiving immunotherapy, including history of non-infectious pneumonitis that required steroids or active autoimmune disease that has required systemic treatment with disease modifying agents, corticosteroids or immunosuppressive drugs in the past two years. Replacement therapy (e.g. thyroxine for pre-existing hypothyroidism, insulin for type I diabetes mellitus, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Intra-articular steroid injections are allowed\n* STEP 1: REGISTRATION (SCREENING): NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system\n\n  * Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines\n  * For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations\n* STEP 2: RANDOMIZATION: Participants must have met all eligibility criteria for Step 1 Registration\n* STEP 2: RANDOMIZATION: Participants must have MammaPrint High Risk 2 result\n\n  * For participants submitting tissue for on-study MammaPrint testing:\n\n    * Participants must be registered to Step 2: Randomization within 84 calendar days (12 weeks) after receiving an MP2 status from the MammaPrint Index score. MP2 status is defined as a MammaPrint Index score between negative 1.0 and negative 0.57 (-1.0 to -0.57, including negative 1.0 and negative 0.57) from initial tumor biopsy OR\n  * Submitting commercial MammaPrint Index Score:\n\n    * If a MammaPrint Index Score report from within the last 12 weeks is already known and is MP2 status, the participant must be registered to Step 2 immediately following Step 1 registration provided they meet all other criteria. MP2 status is defined as a MammaPrint Index score between negative 1.0 and negative 0.57 (-1.0 to -0.57, including negative 1.0 and negative 0.57) tested from initial tumor biopsy\n\n      * NOTE: Participants without a MammaPrint High-Risk 2 score must not be registered to Step 2 Randomization\n* STEP 2: RANDOMIZATION: Participants must not have received live vaccines within 28 days prior to study Step 2: Randomization. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, shingles, yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid (oral) vaccine. Seasonal influenza vaccines and coronavirus disease 2019 (COVID-19) vaccines are allowed; however, intranasal influenza vaccines (e.g. Flu-Mist) are live attenuated vaccines, and are not allowed\n* STEP 2: RANDOMIZATION: Participants must not be planning to receive any concurrent non-protocol directed chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment while receiving treatment on this study\n* STEP 2: RANDOMIZATION: Participant must have Zubrod Performance Status of 0-2\n* STEP 2: RANDOMIZATION: Participants must not have a history of (non-infectious) pneumonitis that required steroids or evidence of active pneumonitis within two years prior to Step 2: Randomization\n* STEP 2: RANDOMIZATION: Participants must not have active autoimmune disease that has required systemic treatment in the past two years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs) prior to Step 2: Randomization. Replacement therapy (e.g. thyroxine for pre-existing hypothyroidism, insulin for type I diabetes mellitus, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Intra-articular steroid injections are allowed\n* STEP 2: RANDOMIZATION: Participant must have a complete medical history and physical exam within 28 days prior to Step 2: Randomization\n* STEP 2: RANDOMIZATION: Leukocytes \\>= 3 x 10\\^3\u002FuL (within 28 days prior to Step 2: Randomization)\n* STEP 2: RANDOMIZATION: Absolute neutrophil count \\>= 1.5 x 10\\^3\u002FuL (within 28 days prior to Step 2: Randomization)\n* STEP 2: RANDOMIZATION: Platelets \\>= 100 x 10\\^3\u002FuL (within 28 days prior to Step 2: Randomization)\n* STEP 2: RANDOMIZATION: Total bilirubin =\\\u003C institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin =\\\u003C 5 x institutional ULN (within 28 days prior to Step 2: Randomization)\n* STEP 2: RANDOMIZATION: Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) =\\\u003C 3 × institutional ULN (within 28 days prior to Step 2: Randomization)\n* STEP 2: RANDOMIZATION: Participants must have a calculated creatinine clearance \\>= 50 mL\u002Fmin using the Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to Step 2: Randomization\n* STEP 2: RANDOMIZATION: Participants must have adequate cardiac function. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2B or better\n* STEP 2: RANDOMIZATION: Participants must not have uncontrolled diabetes defined as hemoglobin A1c of 9.0% or greater, within 28 days prior to Step 2: Randomization\n* STEP 2: RANDOMIZATION: Participants with history of human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have an undetectable viral load on the most recent test results obtained within 6 months prior to Step 2: Randomization\n* STEP 2: RANDOMIZATION: Participants with history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load on the most recent test results obtained while on suppressive therapy within 6 months prior to Step 2: Randomization, if indicated\n* STEP 2: RANDOMIZATION: Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load on the most recent test results obtained within 6 months prior to Step 2: Randomization, if indicated\n* STEP 2: RANDOMIZATION: Participants must not be pregnant or nursing. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method during protocol therapy and for 6 months following completion of protocol therapy with details provided as a part of the consent process and must have a negative pregnancy test at screening. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of \"reproductive potential.\" In addition to routine contraceptive methods, \"effective contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation\u002Focclusion, and vasectomy with testing showing no sperm in the semen. Participants should not breastfeed during protocol therapy and for 6 months following completion of protocol therapy\n* STEP 2: RANDOMIZATION: Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the SWOG Specimen Tracking System\n* STEP 2: RANDOMIZATION: Participants who can complete questionnaires in English, or Spanish must be offered the opportunity to participate in the Quality of Life study\n* STEP 2: RANDOMIZATION: NOTE: As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system\n* STEP 2: RANDOMIZATION: Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines",{"count":51,"type":20},3680,[23],"This phase III trial compares the addition of an immunotherapy drug (durvalumab) to usual chemotherapy versus usual chemotherapy alone in treating patients with MammaPrint High 2 Risk (MP2) stage II-III hormone receptor positive, HER2 negative breast cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as paclitaxel, doxorubicin, and cyclophosphamide work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. There is some evidence from previous clinical trials that people who have a MammaPrint High 2 Risk result may be more likely to respond to chemotherapy and immunotherapy. Adding durvalumab to usual chemotherapy may be able to prevent the cancer from returning for patients with MP2 stage II-III hormone receptor positive, HER2 negative breast cancer.",[26,55,30,56],"Anatomic Stage III Breast Cancer AJCC v8","Hormone Receptor-Positive Breast Carcinoma",{"date":34,"type":35},{"date":59,"type":35},"2023-11-27",{"date":61,"type":20},"2032-05-31",{"name":41,"class":42},543,{"id":65,"slug":4,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":70,"minAge":17,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":21,"phases":73,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":90},"100053408","NCT07699991","A Navigation Program to Improve Survivorship Support Service Participation Among Non-metastatic Breast Cancer Survivors","Implementation of a Navigation Program for Breast Cancer Survivors","Inclusion Criteria:\n\n* GENERAL INCLUSION (PRIMARY OBJECTIVE): Ages 18+\n* GENERAL INCLUSION (PRIMARY OBJECTIVE): Diagnosed with non-metastatic breast cancer\n* GENERAL INCLUSION (PRIMARY OBJECTIVE): Received care at Stefanie Spielman Breast Center\n* COACHING INCLUSION (SECONDARY OBJECTIVE): Referred patients who fall under any of the following:\n\n  * Black and\u002For Hispanic\n  * Ages ≥ 70\n  * Reside in a ZIP code classified as rural by United States Department of Agriculture (USDA) Rural-Urban Commuting Area (RUCA) codes\n\nExclusion Criteria:\n\n* Metastatic breast cancer at time of referral\n* Prisoners or individuals unable to consent\n* Non-English and non-Spanish speakers","FEMALE",{"count":72,"type":20},330,[74],"NA","This clinical trial studies whether a navigation program improves survivorship support service participation among survivors of breast cancer that has not spread from where it first started (primary site) to other places in the body (non-metastatic). Advances in treatment have caused the number of breast cancer survivors to grow. As this number increases, there are reported unmet supportive care needs in this population, including psychological distress and limitations in physical functioning. To address these needs, many cancer centers offer programming on a variety of topics including psychological services, exercise counseling, and nutrition counseling. Research has shown that while interest in these survivorship programs is high, participation remains low, especially among minority women. Navigation is a healthcare service that is designed to guide a patient through the healthcare system and reduce barriers to timely screening, follow-up, diagnosis, treatment, and supportive care. The navigation program in this trial is specifically focused on helping breast cancer survivors schedule and attend survivorship consultation appointments as well as providing additional support to underserved\u002Fvulnerable patients. A navigation program may be effective in improving survivorship support service participation among non-metastatic breast cancer survivors.",[77,78,26,55,79],"Anatomic Stage 0 Breast Cancer AJCC v8","Anatomic Stage I Breast Cancer AJCC v8","Localized Breast Carcinoma","NOT_YET_RECRUITING","2026-07-07",{"date":34,"type":35},{"date":84,"type":20},"2026-09-01",{"date":86,"type":20},"2027-12-31",{"name":88,"class":89},"Ohio State University Comprehensive Cancer Center","OTHER",1,{"id":92,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":21,"phases":94,"briefSummary":24,"conditions":95,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":100,"leadSponsor":101,"locationsCount":102},"100623064",{"count":19,"type":20},[23],[26,27,28,29,30],"2026-07-01",{"date":98,"type":35},"2026-07-02",{"date":37,"type":20},{"date":39,"type":20},{"name":41,"class":42},36,{"id":104,"slug":4,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":21,"phases":111,"briefSummary":112,"conditions":113,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":115,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":122},"100583468","NCT06876714","ShortStop-HER2: 12 Months vs. 6 Months of HER2-targeted Medications for People With HER2+ Breast Cancer Who Had a Pathologic Complete Response After Chemotherapy Plus Trastuzumab","ShortStop-HER2: Shortened Duration of Adjuvant Therapy in Patients With Early-Stage HER2+ Breast Cancer Who Achieve pCR After Neoadjuvant Chemotherapy With HER2 Blockade","Inclusion Criteria:\n\n* Patients (females and males) with clinical stage T1c-T3 (or Tx) and nodal stage N0-N1 (except T3N1 tumors, which are not eligible)\n* Patients must have no residual invasive disease in the breast or lymph nodes after the completion of neoadjuvant therapy. Residual ductal carcinoma in situ (DCIS) is allowed. Patients with residual isolated tumor cells at surgery are considered node-positive and are not eligible\n* HER2+ by American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guidelines. Central pathology review is not required. In cases where there were multiple tumor sites in breast\u002Fnodes that had HER2 testing at diagnosis, at least one site must have been HER2+ AND the treating investigator must feel it is in the patient's best interest to be treated as having HER2+ breast cancer\n* Known hormone receptor status as defined by ASCO\u002FCAP guidelines. Estrogen receptor (ER) and progesterone receptor (PR) of any values are allowed. Hormone receptor positive status can be determined by either known positive ER or known positive PR status; hormone receptor negative status must be determined by both known negative ER and known negative PR\n* If invasive disease was present in both breasts, participation in the study is permitted as long as the eligibility criteria are met for both tumors\u002Fbreasts (including the requirement that at least one biopsied site on each side must have been HER2+)\n* Age ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Patients must have received neoadjuvant chemotherapy in combination with trastuzumab with or without pertuzumab for a minimum of 12 weeks. All chemotherapy must have been completed preoperatively\n\n  * Patient must complete a minimum of 12 weeks of coverage with trastuzumab and a maximum of 24 weeks in the combined neoadjuvant and adjuvant setting prior to trial registration. Trastuzumab may have been administered either weekly or once every 3 weeks (q3weeks). (For purposes of this eligibility criterion, a single dose of q3week trastuzumab would provide 3 weeks of coverage; a single dose of once a week (q1week) trastuzumab would provide 1 week of coverage. If a q3week dose of trastuzumab were administered and then the subsequent dose was delayed for any period of time, that would still count as 3 weeks of coverage.)\n  * Administration of endocrine therapy for treatment of this breast cancer is allowed prior to trial registration. If a patient received prior breast cancer endocrine therapy (eg tamoxifen or aromatase inhibitor) for DCIS or preventive indication, and endocrine therapy is indicated for treatment of their current breast cancer, then prior endocrine therapy must have been stopped \\> 12 months prior to registration on this protocol\n  * No use of investigational anti-cancer agents at time of registration\n* Patient must register within 14 weeks of final surgery\n* Adequate excision: Surgical removal of all clinically evident disease in the breast and lymph nodes as follows:\n\n  * Breast surgery: Total mastectomy with grossly negative margins (in the opinion of the surgeon there is no disease grossly at the margins) or breast-conserving surgery with histologically negative margins (no ink on tumor, including DCIS) unless those margins are anterior at the skin or posterior at the chest wall and no additional margin re-excision can be performed\n  * Lymph node surgery: Lymph node surgery must have been performed and can include sentinel lymph node biopsy, targeted axillary dissection, or axillary dissection, at the discretion of the breast surgeon\n* Adequate radiation: Patients who completed breast-conserving surgery (i.e. lumpectomy) must have received or plan to receive adjuvant radiation. If breast-conserving surgery was performed but patient will not be receiving breast radiation, the patient is not eligible. Patients for whom radiotherapy would be recommended for breast cancer treatment but for whom it is contraindicated because of medical reasons (e.g., connective tissue disorder or prior ipsilateral breast radiation) are not eligible\n\n  * Adjuvant radiation can be given on study, and in this case is encouraged to be given concurrently with adjuvant HER2-directed therapy, per investigator discretion\n  * Targeting of the regional nodal basins will be at treating investigator discretion\n* Not pregnant and not nursing, because this study involves agents with known teratogenic potential. Therefore, for women of childbearing potential only, a negative serum or urine pregnancy test should be performed prior to receiving HER2-directed therapy according to local standard practice\n* Adequate hepatic, renal and bone marrow function to receive adjuvant HER2-directed therapy in the opinion of the treating investigator. There are no specific required laboratory values for eligibility\n* No stage IV (metastatic) breast cancer\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* No history of any prior (ipsilateral \\[ipsi-\\] or contralateral) invasive breast cancer. Prior DCIS is allowed\n* No evidence of recurrent disease following preoperative therapy and surgery\n* Patients living with HIV who are healthy and deemed by their medical team to have a low risk of AIDS-related illnesses are included in this trial. Patients with Hepatitis B or Hepatitis C virus who are healthy and deemed by their medical team to meet all other enrollment criteria are included in this trial.\n* Patients with inadequate cardiac function on most recent assessment of left ventricular ejection fraction (LVEF) are not eligible for this trial. Inadequate cardiac function is defined as LVEF \\\u003C 50% on echocardiogram (echo) or multiple-gated acquisition (MUGA)\n* No history of grade 3 or 4 toxicity related to trastuzumab. If pertuzumab is planned to be given on trial, patient must also have no history of grade 3-4 toxicity related to pertuzumab\n* No contraindication to receipt of further HER2-directed therapy\n* No patients with severe, uncontrolled systemic disease that may interfere with planned trial therapy.\n\nExclusion Criteria:\n\n\\-",{"count":110,"type":20},1524,[23],"This phase III trial compares 6 months of human epidermal growth factor receptor 2 (HER2)-targeted therapy to 12 months of HER2-targeted therapy for the treatment of HER2-positive (+) breast cancer in patients that had a pathologic complete response (pCR) after preoperative (neoadjuvant) chemotherapy with trastuzumab. Trastuzumab and pertuzumab are monoclonal antibodies and forms of targeted therapy that attach to a receptor protein called HER2. HER2 is found on some cancer cells. When trastuzumab or pertuzumab attach to HER2, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Giving 6 months of HER2-targeted therapy may work better than giving 12 months for the treatment of HER2+ breast cancer in patients that had a pCR after neoadjuvant chemotherapy with trastuzumab.",[78,26,114],"Early Stage HER2+ Breast Cancer",{"date":98,"type":35},{"date":117,"type":35},"2025-09-17",{"date":119,"type":20},"2037-03-13",{"name":121,"class":89},"Alliance for Clinical Trials in Oncology",671,{"id":124,"slug":4,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":125,"targetDuration":4,"studyType":21,"phases":126,"briefSummary":53,"conditions":127,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":128,"startDateStruct":129,"completionDateStruct":130,"leadSponsor":131,"locationsCount":132},"100520577",{"count":51,"type":20},[23],[26,55,30,56],{"date":98,"type":35},{"date":59,"type":35},{"date":61,"type":20},{"name":41,"class":42},541,{"id":134,"slug":4,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":21,"phases":141,"briefSummary":142,"conditions":143,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":146,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":152},"100501711","NCT05812807","Pembrolizumab vs. Observation in People With Triple-negative Breast Cancer Who Had a Pathologic Complete Response After Chemotherapy Plus Pembrolizumab","OptimICE-PCR: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy With Checkpoint Inhibitor Therapy","Inclusion Criteria:\n\n* Age \\>= 18 years\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2\n* Triple Negative Breast Cancer:\n\n  * Patients with a history of clinical stage T1cN1-2 or T2-4N0-2 (clinical stage II or III prior to preoperative therapy) breast cancer at time of diagnosis according to the primary tumor-regional lymph node anatomic staging criteria of the American Joint Committee on Cancer (AJCC), 8th edition as determined by the investigator in radiologic assessment, clinical assessment or both\n  * Patients must have no residual invasive disease in the breast or lymph nodes after the completion of neoadjuvant therapy. Residual ductal carcinoma in situ (DCIS) is allowed. Isolated tumor cells are considered node-negative\n  * Estrogen receptor (ER) and progesterone receptor (PR) =\\\u003C 10%; HER2-negative by American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guidelines (immunohistochemistry \\[IHC\\] and fluorescence in situ hybridization \\[FISH\\])\n  * If invasive disease was present in both breasts, participation in the study is permitted as long as the eligibility criteria are met for both tumors\u002Fbreasts\n* Patients must have received neoadjuvant chemotherapy in combination with pembrolizumab for a minimum of 6 cycles. All systemic chemotherapy must have been completed preoperatively\n* An interval of no more than 12 weeks between the completion date of the final surgery and the date of randomization\n\n  \\* Note: Adjuvant radiation can be given on study, however, it is recommended to complete adjuvant radiation prior to registration. If radiation is given on study, it is encouraged to be given concurrently with pembrolizumab if the patient is on the pembrolizumab arm, per investigator discretion. Treatment with adjuvant pembrolizumab is strongly discouraged prior to participation in this trial, but if administered (e.g., if patients are awaiting pathology results), pembrolizumab may be administered for up to 6 weeks (i.e., up to 2 q3week doses or up to one q6week dose) post-surgery and must be completed prior to registration post-surgery and must be completed prior to registration\n* Use of investigational anti-cancer agents must be discontinued at time of registration\n* Adequate excision: Surgical removal of all clinically evident disease in the breast and lymph nodes as follows:\n\n  * Breast surgery: Total mastectomy or breast-conserving surgery with histologically negative margins, including no ink on tumor for DCIS, at the time of excision\n\n    \\*\\* For patients who undergo breast-conserving surgery, the margins of the resected specimen must be histologically free of ductal carcinoma in-situ (DCIS) as determined by the local pathologist. If pathologic examination demonstrates DCIS at the line of resection, additional operative procedures may be performed to obtain clear margins. If DCIS is still present at the resected margin after re-excision(s), the patient must undergo total mastectomy to be eligible. Patients with margins positive for classic lobular carcinoma in situ (LCIS) are eligible without additional resection\n  * Lymph node surgery:\n\n    * For a patient with clinically N0 disease, a sentinel lymph node biopsy should have been performed at time of surgical evaluation, and if pathologically node positive, the patient is no longer eligible. Isolated tumor cells are considered node-negative\n    * For a patient with clinically N1 disease at diagnosis (with positive results from a fine-needle aspiration, core biopsy, or sentinel node biopsy performed prior to preoperative therapy) additional surgical evaluation of the axilla following preoperative therapy is required\n\n      \\*\\*\\* If they become cN0 (no palpable adenopathy), then a sentinel lymph node biopsy could have been performed at time of surgery (axillary dissection would also be permitted); if the sentinel lymph node biopsy is positive, the patient is no longer eligible\n    * If sentinel node biopsy performed before preoperative therapy was negative, no additional surgical evaluation of the axilla is required after preoperative therapy. If sentinel node biopsy performed before preoperative therapy was positive, an ALND is required after preoperative therapy\n    * If the only sentinel node identified by isotope scan is in the internal mammary chain, surgical evaluation of the axilla is still required\n    * If sentinel node evaluation after preoperative therapy is negative, no further additional surgical evaluation of the axilla is required\n    * Axillary dissection without sentinel node evaluation is permitted as the initial or sole axillary evaluation after preoperative therapy\n* If breast-conserving surgery was performed but patient will not be receiving breast radiation, the patient is not eligible\n* Not pregnant and not nursing, because this study involves an agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown. Therefore, for women of childbearing potential only, a negative serum or urine pregnancy test done =\\\u003C 7 days prior to randomization is required\n* Absolute neutrophil count (ANC) \\>= 1,000\u002Fmm\\^3\n* Platelet Count \\>= 100,000\u002Fmm\\^3\n* Estimated glomerular filtration rate (eGFR) \\>= 15 mL\u002Fmin\u002F1.73m\\^2\n* Total Bilirubin =\\\u003C1.5 x upper limit of normal (ULN)\n\n  \\* Patients with Gilbert's disease with a total bilirubin =\\\u003C 2.5 x ULN and direct bilirubin within normal limits are permitted\n* Aspartate aminotransferase (AST) serum aspartate aminotransferase \\[SGOT\\] \u002F alanine aminotransferase (ALT) serum glutamic pyruvic transaminase \\[SGPT\\] =\\\u003C 3 x institutional ULN\n* Patients must be willing to provide tumor tissue from the diagnostic core biopsy. If inadequate tumor tissue is available, patients are still eligible to participate in the trial\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better\n* Patients with known HIV infection who are on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial\n\nExclusion Criteria:\n\n* No stage IV (metastatic) breast cancer\n* No history of any prior (ipsi- or contralateral) invasive breast cancer. Prior DCIS is allowed\n* No evidence of recurrent disease following preoperative therapy and surgery\n* No known active liver disease, e.g. due to hepatitis B virus (HBV), hepatitis C virus (HCV), autoimmune hepatic disorders, or sclerosing cholangitis\n* No history of intolerance, including Grade 3 or 4 infusion reaction or hypersensitivity to pembrolizumab or murine proteins or any components of the product\n\n  \\* Note: Prior immune-related adverse events (irAEs) are allowed if they resolved to ≤ grade 1 and the patient tolerated subsequent therapy without requiring chronic steroids for the irAE. The following are exceptions to this criterion: Grade 2 or lower immune mediated endocrinopathies due to neoadjuvant checkpoint inhibition but patients are stable on endocrine therapy and were able to continue checkpoint inhibition.\n* No medical conditions that require chronic systemic steroids (\\>10 mg prednisone daily or equivalent) or any other form of immunosuppressive medications and has required such therapy in the last two years. Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic therapy\n* Patients who are unable or unwilling to comply with the requirements of the protocol per investigator assessment are not eligible",{"count":140,"type":20},1295,[23],"This phase III trial compares the effect of continuation of treatment with pembrolizumab (usual approach) to observation only at preventing cancer from coming back in patients with early-stage triple-negative breast cancer (TNBC) who achieved a pathologic complete response after preoperative chemotherapy in combination with pembrolizumab. The usual approach for patients with early-stage TNBC who receive preoperative chemotherapy plus pembrolizumab is to continue to receive pembrolizumab for up to 27 weeks after surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial may help researchers determine if observation is as good as receiving pembrolizumab for 27 weeks after surgery in triple-negative breast cancer patients who achieved a pathologic complete response after preoperative treatment with chemotherapy and pembrolizumab.",[26,144,27,145],"Early Stage Triple-Negative Breast Carcinoma","Anatomic Stage IIIB Breast Cancer AJCC v8",{"date":98,"type":35},{"date":148,"type":35},"2023-06-14",{"date":150,"type":20},"2033-05-31",{"name":121,"class":89},842,{"id":154,"slug":4,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":4,"eligibilityCriteria":158,"healthyVolunteers":11,"sex":70,"minAge":17,"maxAge":4,"enrollmentInfo":159,"targetDuration":4,"studyType":21,"phases":161,"briefSummary":162,"conditions":163,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":174},"100491336","NCT05677802","Feasibility Study of Biobehavioral Stress Reduction Intervention in Patients With Triple Negative Breast Cancer","Examining the Feasibility of Implementing a Biobehavioral Stress Reduction Program in Triple Negative Breast Cancer Patients","Inclusion Criteria:\n\n* Age \\>=18 years\n* Untreated newly diagnosed triple negative breast cancer\n* Stages I-III\n\nExclusion Criteria:\n\n* Prisoners\n* Male\n* Identifying as American Indian, Alaska Native, Asian, Native Hawaiian or Other Pacific Islander\n* Individuals not able to speak and understand English\n* Known personal history of ductal carcinoma in situ (DCIS) or invasive breast cancer\n* Stage IV breast cancer",{"count":160,"type":20},40,[74],"This clinical trial aims to see if patients with triple negative breast cancer can complete a biobehavioral stress reduction program that also addresses health related social needs (e.g., utilities, transportation, etc.). The stress reduction program is over ten weeks and includes stress reduction (e.g., progressive muscle relaxation), coping, problem solving, communication, and social support. Health related social needs will be evaluated at the beginning of the study, and referrals will be made to social work to help address those needs. The study will examine stress as reported by the patients and also use biological markers.",[78,26,55,30,164,165],"Hormone Receptor-Negative Breast Carcinoma","Triple-Negative Breast Carcinoma","2026-06-24",{"date":168,"type":35},"2026-06-29",{"date":170,"type":35},"2022-12-14",{"date":172,"type":20},"2027-06-30",{"name":88,"class":89},2,{"id":176,"slug":4,"hasResults":11,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":4,"eligibilityCriteria":180,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":181,"targetDuration":4,"studyType":21,"phases":183,"briefSummary":185,"conditions":186,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":90},"100624306","NCT07407920","Ph2 Study for Optimization of Adjunct Systemic Therapy in HER2+ Patients, MolecularPCR Trial","Optimization of Adjuvant Systemic Therapy in Patients With Early HER2-Positive (HER2+) Breast Cancer or Triple Negative Breast Cancer (TNBC) That Achieved a Pathological Complete Response (pCR) After Neoadjuvant Systemic Therapy and Do Not Have Molecular Residual Disease (MRD-Negative): A Phase II Clinical Trial (The MolecularPCR Trial)","Inclusion Criteria:\n\n* EARLY HER2 POSITIVE (+) BREAST CANCER COHORT: Female or male with a diagnosis of biopsy proven invasive breast cancer HER2+, hormone (estrogen and progesterone)-receptor positive or negative. The HER2 status (following American Society of Clinical Oncology \\[ASCO\\]\u002FCollege of American Pathologists \\[CAP\\] guidelines) and hormone-receptor status will be determined according to institutional (local) guidelines\n* EARLY TNBC COHORT: Female or male with a diagnosis of biopsy proven invasive TNBC (estrogen and progesterone receptor \\\u003C 10%). The HER2 status (following ASCO\u002FCAP guidelines) and hormone-receptor status will be determined according to institutional (local) guidelines\n* FOR BOTH HER2+ AND TNBC COHORTS: Invasive breast cancer of any tumor histologic grade and\u002For nuclear grade, and any tumor histological subtype including but not limited to infiltrating ductal carcinoma, infiltrating lobular carcinoma, mucinous carcinoma, papillary carcinoma, tubular carcinoma, metaplastic carcinoma, and mixed histology\n* FOR BOTH HER2+ AND TNBC COHORTS: Clinical tumor stage (per American Joint Committee on Cancer \\[AJCC\\] 8th edition): T1-4, N0-2a, M0. Patients who have a diagnosis of inflammatory breast cancer are eligible. Patients should not have clinical evidence of locoregional or distant metastatic breast cancer\n* EARLY HER2+ BREAST CANCER COHORT: Have completed NST with a trastuzumab plus pertuzumab and chemotherapy-based regimen (for example, docetaxel plus minus carboplatin plus trastuzumab plus pertuzumab known as the docetaxel\u002Fpertuzumab\u002Ftrastuzumab \\[THP\\]\u002Fcarboplatin\u002Fpaclitaxel\u002Fpertuzumab\u002Ftrastuzumab \\[TCHP\\] regimens) followed by definitive breast surgery where the surgical pathology reports a pCR (ypT0-Tis, ypN0) and are willing to discontinue adjuvant trastuzumab plus pertuzumab\n* EARLY TNBC COHORT: Have completed NST with a pembrolizumab plus chemotherapy-based regimen (for example, the KEYNOTE-522 regimen which is paclitaxel plus carboplatin plus pembrolizumab followed by doxorubicin plus cyclophosphamide plus pembrolizumab) followed by definitive breast surgery where the surgical pathology reports a pCR (ypT0-Tis, ypN0) and are willing to discontinue adjuvant pembrolizumab\n* The surgical pathology report needs to show a pCR (ypT0-Tis, ypN0) for a patient to be able to participate in this study and all enrolled patients should be willing to discontinue standard adjuvant systemic therapy\n* FOR BOTH HER2+ AND TNBC COHORTS: Adequate archival tumor tissue from the core diagnostic biopsy (per Personalis)\n* FOR BOTH HER2+ AND TNBC COHORTS: Age ≥ 18 years\n* FOR BOTH HER2+ AND TNBC COHORTS: Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)\n* FOR BOTH HER2+ AND TNBC COHORTS: Absolute neutrophil count ≥ 1,000\u002FmcL\n* FOR BOTH HER2+ AND TNBC COHORTS: Hemoglobin ≥ 9.0 g\u002FdL\n* FOR BOTH HER2+ AND TNBC COHORTS: Platelets ≥ 100,000\u002FmcL\n* FOR BOTH HER2+ AND TNBC COHORTS: Total bilirubin ≤ 1.5 institutional upper limit of normal (ULN); patients with Gilbert's syndrome (if direct bilirubin \\\u003C1.5 x institutional ULN)\n* FOR BOTH HER2+ AND TNBC COHORTS: Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002F alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3 × institutional ULN\n* FOR BOTH HER2+ AND TNBC COHORTS: Creatinine ≤ 1.5 mg\u002FdL\n* FOR BOTH HER2+ AND TNBC COHORTS: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* FOR BOTH HER2+ AND TNBC COHORTS: Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* FOR BOTH HER2+ AND TNBC COHORTS: Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible\n* FOR BOTH HER2+ AND TNBC COHORTS: Pre- and postmenopausal women are eligible\n* FOR BOTH HER2+ AND TNBC COHORTS: Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Patients with tumor stage of cN2b or cN3 are not eligible\n* History of other malignancies besides breast cancer within the past 5 years, except cervical cancer in situ, melanoma in situ, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin\n* Patients who are receiving any other anti-cancer investigational agents\n* Patients with known cancer metastases from any site\n* Patients with uncontrolled intercurrent illness including but not limited to active infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic cardiac arrythmias\n* Patients with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Blood transfusion within 2 weeks before collection of blood for ctDNA testing\n* Patients who have received 4 or more cycles of SOC adjuvant trastuzumab\u002Fpertuzumab (HER2+) or 4 or more cycles of SOC adjuvant pembrolizumab (TNBC)\n* Pregnant women are not eligible to participate in this study",{"count":182,"type":20},120,[184],"PHASE2","This phase II trial tests reduced post surgery (adjuvant) therapy for patients with early breast cancer who have confirmed that the disease has responded completely (pathologic complete response) after pre surgical treatment (neoadjuvant) therapy and do not have any tumor genetic material (molecular residual disease) circulating in their blood. Standard of care treatment after surgery consists of 1 year of pembrolizumab for patients with triple negative breast cancer or trastuzumab with or without pertuzumab to complete 1 year of treatment. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Pertuzumab and trastuzumab are monoclonal antibodies and forms of targeted therapy that attach to a receptor protein called HER2. HER2 is found on some cancer cells. When pertuzumab or trastuzumab attach to HER2, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Lowering the total amount of cancer therapy after breast surgery, may continue to keep the great tumor response to treatment, and may help lower the amount of side effects patients have.",[78,26,187,144],"Early Stage HER2-Positive Breast Carcinoma","2026-06-23",{"date":166,"type":35},{"date":191,"type":35},"2025-10-09",{"date":193,"type":20},"2027-09-30",{"name":195,"class":89},"M.D. Anderson Cancer Center",{"id":197,"slug":4,"hasResults":11,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":4,"eligibilityCriteria":201,"healthyVolunteers":11,"sex":70,"minAge":17,"maxAge":4,"enrollmentInfo":202,"targetDuration":4,"studyType":21,"phases":204,"briefSummary":205,"conditions":206,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":90},"100605092","NCT07158021","Leuprolide and Goserelin for Ovarian Function Suppression in Pre- or Peri-menopausal Women With Breast Cancer, OFS Trial","Phase 2 Interventional Trial of Ovarian Function Suppression for Breast Cancer (OFS)","Inclusion Criteria:\n\n* Female subject aged ≥ 18 years\n* Pre- or peri-menopausal patient, who had (1) menses either within the 12 months prior to or since breast cancer diagnosis or (2) estradiol concentration above the postmenopausal range per institutional laboratory guidance either within the 12 months prior to or since breast cancer diagnosis.\n* Planning to take GnRHa therapy in combination with oral endocrine therapy (tamoxifen, anastrozole, exemestane, or letrozole) for adjuvant treatment of stage 1-3 breast cancer or for treatment of metastatic breast cancer. Prior treatment with GnRHa therapy for treatment of non-oncologic conditions or during chemotherapy is permitted.\n* Not planning bilateral salpingo-oophorectomy during the 6-month study duration\n* Completion of chemotherapy, if given. Concurrent use of trastuzumab, pertuzumab, bisphosphonate therapy, poly adenosine diphosphate-ribose polymerase (PARP) inhibitor therapy, cyclin D kinase 4\u002F6 (CDK4\u002F6) inhibitor, and\u002For phosphoinositide 3-kinase (PI3K) inhibitor therapy is permitted\n* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines\n\nExclusion Criteria:\n\n* Prior bilateral salpingo-oophorectomy\n* Known to be pregnant or breastfeeding (negative pregnancy test will be confirmed prior to study treatment initiation)\n* Concomitant use of systemic or transdermal estrogen products\n* Known allergy or hypersensitivity to goserelin or leuprolide, or any of the excipients in the medications\n* Unable to take oral medications\n* Any medical condition that would interfere with the absorption of endocrine therapy. Prior gastric bypass is permitted\n* Patients with a prior or concurrent malignancy whose natural history or treatment, in the opinion of the treating investigator, has the potential to interfere with the safety or efficacy assessment of the investigational regimen",{"count":203,"type":20},75,[184],"This phase II trial compares leuprolide to goserelin for reducing estrogen production by the ovaries in pre- or peri-menopausal women with breast cancer. Estrogen can cause the growth of breast cancer cells. Both leuprolide and goserelin lower the amount of estrogen made by the body. This may help stop the growth of tumor cells that need estrogen to grow. This study compares lower dose leuprolide, higher dose leuprolide, and goserelin for their ability to suppress the function of the ovaries to produce estrogen. Both doses of leuprolide may be as safe, tolerable and\u002For effective as goserelin in suppressing ovarian function in pre- or peri-menopausal women with breast cancer.",[78,26,55,207,208],"Anatomic Stage IV Breast Cancer AJCC v8","Metastatic Breast Carcinoma","2026-06-18",{"date":188,"type":35},{"date":212,"type":35},"2026-01-22",{"date":214,"type":20},"2028-01-01",{"name":216,"class":89},"University of Michigan Rogel Cancer Center",{"id":218,"slug":4,"hasResults":11,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":4,"eligibilityCriteria":222,"healthyVolunteers":11,"sex":70,"minAge":17,"maxAge":4,"enrollmentInfo":223,"targetDuration":4,"studyType":21,"phases":225,"briefSummary":226,"conditions":227,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":90},"100510749","NCT05930483","Remotely Delivered, Community-Aligned Weight Loss Interventions Among Breast Cancer Survivors, ¡Vida! Trial","Using a SMART Design to Evaluate Remotely Delivered, Community-aligned Weight Loss Interventions Among Breast Cancer Survivors: The ¡Vida! Study","Inclusion Criteria:\n\n* Biologically female\n* Age \\>= 18 years\n* Self-identifies Hispanic\u002FLatina\n* Able to read and write in Spanish and\u002For English\n* Previous diagnosis of stage I-III BC within the past 5 years\n* No evidence of current, recurrent, or metastatic disease\n* 60 days post treatment, including chemotherapy, radiation therapy, and cancer-related surgery (NOTE: current allowed therapies include endocrine therapy, CDK4\u002F6 inhibitors (e.g. palbociclib,ribociclib, abemaciclib), HER2-directed therapies (e.g., trastuzumab, neratinib), and monoclonal antibodies (e.g., pertuzumab, pembrolizumab); surgery for breast reconstruction is allowed during the trial)\n* Body mass index (BMI) \\>= 27 kg\u002Fm\\^2 initially assessed via self-reported height and weight and confirmed prior to randomization via a tape measure and Bluetooth-enabled scale\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1\n* Willingness to participate in all study activities\n* Access to phone for study contacts\n* Access to internet to participate in the online program and to be able to sync study devices\n* Successful completion of at-home baseline assessments prior to randomization\n\nExclusion Criteria:\n\n* Body mass index (BMI) \\\u003C 27 kg\u002Fm\\^2 at time of baseline data collection\n* Diabetic with current use of insulin or sulfonylurea medications (note: current use of metformin is allowed)\n* Use of glucagon-like peptide-1 (GLP1) receptor agonist medications reported at baseline\n* Current use of cytotoxic chemotherapy medications (e.g., capecitabine) or drug-antibody conjugates (e.g., trastuzumab emtansine \\[T-DM1\\], trastuzumab deruxtecan \\[T-DXd\\])\n* Major comorbidities or physical limitations that would preclude from healthy weight loss, reducing energy intake or engaging in PA\n* Pregnant, breastfeeding, or planning to become pregnant during the study period\n* Use of exogenous hormones for gender affirmation\n* For stool sample collection only: Self-reported use of oral or intravenous antibiotics, antifungals, or anti-parasitics during the past 6 months\n* For stool sample collection only: Presence of self-reported ileostomy or colostomy\n* For stool sample collection only: Presence of self-reported inflammatory bowel diseases (e.g., Crohn's disease, ulcerative colitis)\n* Anticipated major surgical procedure (e.g., hysterectomy) within 3 months after study registration. Breast reconstruction is allowed during study participation.\n* Concurrent enrollment in another weight loss or physical activity trial",{"count":224,"type":20},640,[74],"This clinical trial evaluates remotely delivered, community-aligned weight loss interventions in Latina breast cancer survivors. Breast cancer is the second leading cause of cancer death among women in the US. There are population differences in breast cancer mortality, based on specific risk factors, including obesity. Cancer is the leading cause of death among Latinos, and among Latinas, breast cancer is the leading cause of cancer death. An estimated 80% of Latinas in the United States have overweight\u002Fobesity, which is associated with poorer breast cancer outcomes. However, few, if any, effective interventions exist to promote and maintain weight loss in Latina breast cancer survivors. The development of an adaptive program that provides survivors with the support they need, as opposed to what is typically available, to improve breast cancer survivorship.",[78,26,55],"2026-06-16",{"date":209,"type":35},{"date":231,"type":35},"2025-04-08",{"date":233,"type":20},"2028-03-01",{"name":235,"class":89},"Fred Hutchinson Cancer Center",{"id":237,"slug":4,"hasResults":11,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":4,"eligibilityCriteria":241,"healthyVolunteers":11,"sex":70,"minAge":242,"maxAge":4,"enrollmentInfo":243,"targetDuration":4,"studyType":21,"phases":245,"briefSummary":246,"conditions":247,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":90},"100618396","NCT07331077","A Physical Activity Program Compared to Health Education for Improving Memory and Attention in Hispanic Women With Newly-Diagnosed Stage I-IIIa Breast Cancer, MAMA Trial","Movement and Memory After Breast Cancer: The MAMA Trial","Inclusion Criteria:\n\n* PRE-REGISTRATION: Age \\>= 50 years at time of pre-registration visit according to participant report and\u002For clinical determination\n* PRE-REGISTRATION: Self-identifies as Hispanic (any race)\n* PRE-REGISTRATION: First time, primary diagnosis of Stage I-IIIa breast cancer according to participant report and\u002For clinical determination\n* PRE-REGISTRATION: Post-surgery and completed primary adjuvant treatment (i.e., surgery, chemotherapy, and\u002For radiation therapy) 3-36 months prior to preregistration according to participant report and\u002For clinical determination\n* PRE-REGISTRATION: Sedentary except for casual lifestyle recreation, self-reporting no more than 90 minutes per week of moderate-intensity aerobic exercise within the last 6 months\n* PRE-REGISTRATION: Self-reported ability to complete assessments by themselves or with assistance\n* REGISTRATION: Age \\>= 50 years or older as confirmed via clinical determination\n* REGISTRATION: Self-identifies as Hispanic (any race)\n* REGISTRATION: Able to provide medical record release to confirm eligibility\n* REGISTRATION: First time, primary diagnosis of Stage I-IIIa breast cancer as confirmed via clinical determination\n* REGISTRATION: Post-surgery and completed primary treatment (i.e., surgery, chemotherapy, and\u002For radiation therapy) 3-36 months prior to pre-registration as confirmed via clinical determination\n* REGISTRATION: No evidence of possible cognitive impairment as assessed using the Telephone Interview of Cognitive status (13-item modified version) (TICS-M; score \\>= 21)\n* REGISTRATION: Receive physician's clearance to participate in an exercise program\n\n  * NOTE: Individuals with conditions\u002Fdiagnoses deemed important by the primary investigator will be required to provide clearance for exercise from their cardiologist. Example conditions include:\n\n    * History of major multiple myocardial infarctions (MI)\n    * Recent electrocardiogram (ECG) changes or recent MI\n    * Resting or unstable angina\n    * Significant multivessel coronary occlusion (\\>= 70%) on angiography\n    * Uncontrolled and\u002For serious arrhythmias\n    * 3rd degree heart block\n    * Acute congestive heart failure or ejection fraction \\\u003C 30%\n* REGISTRATION: Ability to complete assessments by themselves or with assistance\n* REGISTRATION: Agree to be randomized\n\nExclusion Criteria:\n\n* PRE-REGISTRATION: Stage 0 breast cancer diagnosis OR metastatic disease\n* PRE-REGISTRATION: Currently receiving or \\\u003C 3 months since receiving chemotherapy or radiation therapy for cancer, or greater than 36 months post primary treatment\n* PRE-REGISTRATION: Planned surgery during the intervention period\n* PRE-REGISTRATION: Secondary cancer diagnosis (excluding non-invasive skin cancers, carcinoma-in-situ for any cancer)\n* PRE-REGISTRATION: Unable to regularly attend the study locations for intervention sessions and data collection\n* PRE-REGISTRATION: Unwilling to return to enrolling institution for follow-up\n* PRE-REGISTRATION: Self-reported inability to walk without assistance or devices\n* PRE-REGISTRATION: Self-reported pregnancy\n* REGISTRATION: History of stroke, transient ischemic attack, other neurological disorders, or brain surgery involving tissue removal as confirmed via clinical determination\n* REGISTRATION: Clinically significant TICS-M score (\\\u003C 21) during baseline procedures\n* REGISTRATION: Not able to provide physician re-clearance for exercise if required based upon clinically significant baseline exercise test (as determined by ECG and blood pressure monitoring)\n* REGISTRATION: Contraindications to functional magnetic resonance imaging (fMRI) in accordance with the Mayo Clinic Department of Radiology safety protocols\n* REGISTRATION: Clinically significant magnetic resonance imaging (MRI) scan as determined by physician review in which the following is advised via radiologist overread: remarkable\u002Fabnormal limited diagnostic brain image with recommended medical follow-up\n* REGISTRATION: Enrolled in another physical activity program\n* REGISTRATION: Unable to walk without assistance or devices\n* REGISTRATION: Unwilling to complete study requirements\n* REGISTRATION: Unwilling to be randomized to the exercise group or health education group\n* REGISTRATION: Unable to regularly attend study locations for intervention sessions and data collection\n* REGISTRATION: Unwilling to return to enrolling institution for follow-up\n* REGISTRATION: Unable to complete the study in English or Spanish\n* REGISTRATION: Self-reported pregnancy","50 Years",{"count":244,"type":20},10,[74],"This clinical trial compares a physical activity program to a health education program for improving memory and attention in Hispanic women who are 50 years of age or older and are newly-diagnosed with stage I-IIIa breast cancer. Compared to non-Hispanic White breast cancer survivors (BCS), Hispanic BCS report greater depressive symptoms, emotional distress, anxiety, fear of recurrence, pain, fatigue, and financial toxicity, in addition to more cancer-related psychosocial needs and lower quality of life and social well-being. Cancer-associated cognitive decline (CACD) is a related symptom that has gained increasing attention in clinical research. Based on disparities in other outcomes, it is likely that Hispanic BCS also experience greater CACD than non-Hispanic White BCS, but interventions targeting CACD in Hispanic BCS are non-existent and critically needed. The benefits of aerobic exercise among BCS are well documented and include improvement in health outcomes that are associated with cognitive function including fatigue, anxiety, depression, and sleep. A physical activity program that includes aerobic exercise may be more effective than simple health education for improving cognitive functions like memory and attention in Hispanic women who are 50 years of age or older and are newly-diagnosed with stage I-IIIa breast cancer.",[78,26,27,248],"Cancer-related Cognitive Dysfunction","2026-06-15",{"date":228,"type":35},{"date":252,"type":20},"2026-10-01",{"date":254,"type":20},"2027-11-30",{"name":256,"class":89},"Mayo Clinic",{"id":258,"slug":4,"hasResults":11,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":262,"eligibilityCriteria":263,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":264,"enrollmentInfo":265,"targetDuration":4,"studyType":21,"phases":266,"briefSummary":267,"conditions":268,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":273,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":174},"100629393","NCT07474090","Personalized Exercise Program for Survivors of Breast Cancer, STEPS-BC Trial","Supportive Tailored Exercise Program for Survivors of Breast Cancer (STEPS-BC)","STEPS-BC","Inclusion Criteria:\n\n* Stage I-III breast cancer (including inflammatory and newly diagnosed, or locally recurrent \\[if prior treatment received ≥ 2 years prior\\] but not metastatic breast cancer being treated with curative intent). All molecular subtypes (estrogen receptor \\[ER\\], progesterone receptor \\[PR\\], human epidermal growth factor receptor 2 \\[HER2\\], etc.) are acceptable\n* Scheduled to receive neoadjuvant or adjuvant cytotoxic chemotherapy. Patient must be enrolled ≤ 3 weeks from start of cytotoxic chemotherapy\n* Age 18 to 85 years at enrollment. The upper age cut-off is due to the increased risk of injury in the older population during the CPET, which uses stationary bicycle exercise testing, outweighing the benefit of including this age group\n* Must be able to complete a stationary bicycle exercise test where you pedal against some resistance on a stationary bike with supervisors at your side per patient self-report\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n* Able to walk at least 2 blocks without chest pain, dyspnea, shortness of breath or fainting per patient self-report\n* Able to hold breath for 8 seconds\n* Must be able to read and understand English language\n* Must have access to a device that allows teleconferencing (e.g., Zoom calls) or be willing to participate in the Tablet Lending Program\n* Must be willing to download and use the Trainerize application to their personal device or be willing to participate in the Tablet Lending Program\n* Must have a working email address to participate in teleconferencing (e.g., Zoom calls). Local National Cancer Institute Community Oncology Research Program (NCORP) site staff may assist in setting up a new email address, if needed\n\nExclusion Criteria:\n\n* At enrollment, the following diagnosis and\u002For conditions may not be present (i.e., documented in the medical record or by patient self-report):\n\n  * Symptomatic claustrophobia\n  * Pregnancy or breast-feeding\n  * Ferromagnetic cerebral aneurysm clips or other intraorbital\u002Fintracranial metal; pacemakers, defibrillators, functioning neurostimulator devices or other implanted non-compatible MRI devices, such as tissue expanders\n  * Uncontrolled hypertension (systolic blood pressure \\> 190 mm Hg or diastolic blood pressure \\> 100 mm Hg)\n  * Inflammatory conditions such as lupus or inflammatory bowel disease, or another medical condition that might compromise safety or successful completion, as determined by the treating physician\n  * Significant ventricular arrhythmias (\\> 20 premature ventricular contractions \\[PVCs\\]\u002Fmin)\n  * Atrial fibrillation with uncontrolled ventricular response (\\> 130 beats per minute \\[bpm\\])\n  * Unstable or stable angina (cardiac chest pain)\n  * Severe pulmonary hypertension\n  * Left main coronary artery disease\n  * Symptomatic heart failure\n  * Severe valvular heart disease\n  * Aortic aneurysm (\\> 45 mm diameter) or aortic dissection\n  * Uncontrolled slow or fast heart rhythm causing symptoms or hemodynamic compromise\n  * Hypertrophic obstructive cardiomyopathy\n* Acute myocardial infarction within 28 days of enrollment\n* Acute pulmonary embolus and\u002For deep vein thrombosis within 24 weeks prior to enrollment\n* Plans to relocate within 6 months of enrollment and unable to participate in study procedures\n* May not be on a simultaneous interventional supportive care (non-therapeutic) clinical trial\n* May not be undergoing simultaneous treatment for a concurrent second primary cancer (patients with historical cancer will not be excluded if chemotherapy was received ≥ 2 years prior)\n* May not be currently engaged in ≥ 300 minutes of moderate to vigorous intensity physical activity per week as determined by self-report on the International Physical Activity Questionnaire -Short Form (IPAQ-SF). Site should use the IPAQ-SF screener in the REDCap WF-2401 STEPS-BC screening project to assist in this determination","85 Years",{"count":182,"type":20},[74],"This clinical trial studies whether a healthy living intervention (HLI), with or without a physical activity intervention (PAI), helps maintain the ability to exercise, heart health, and quality of life in breast cancer patients who are scheduled to receive chemotherapy treatment. Early detection and enhanced therapies for breast cancer have improved 5-year cancer-related survival rates. Unfortunately, many breast cancer survivors are at high risk for long-term exercise intolerance, decreased heart health, and lower quality of life following chemotherapy. Currently, there are no effective therapies to help patients maintain these areas throughout chemotherapy. The HLI in this study includes virtual health education classes, which provide useful information on topics like proper nutrition, managing stress, and sleep practices. This may help patients understand the importance of living a healthy lifestyle during chemotherapy. The PAI in this study consists of virtual exercise sessions personalized to the needs of the patient, which may make it easier for patients to stay active during chemotherapy. HLI with PAI may be a more effective way to help maintain ability to exercise, heart health, and quality of life in breast cancer patients who are scheduled to receive chemotherapy treatment.",[78,26,55,269,270,271],"Breast Carcinoma","Breast Inflammatory Carcinoma","Locally Recurrent Breast Carcinoma","2026-06-12",{"date":249,"type":35},{"date":275,"type":35},"2026-05-27",{"date":277,"type":20},"2030-04-30",{"name":279,"class":89},"Wake Forest University Health Sciences",{"id":281,"slug":4,"hasResults":11,"nctId":282,"briefTitle":283,"officialTitle":284,"acronym":4,"eligibilityCriteria":285,"healthyVolunteers":11,"sex":70,"minAge":17,"maxAge":4,"enrollmentInfo":286,"targetDuration":4,"studyType":288,"phases":4,"briefSummary":289,"conditions":290,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":293,"startDateStruct":294,"completionDateStruct":296,"leadSponsor":298,"locationsCount":90},"100402252","NCT04517838","Immune Response to Anti-HER2 Therapies in Patients With HER2-Positive Stage I-IV Breast Cancer","Immune Response to Anti-HER2 Therapies","Inclusion Criteria:\n\n* Age \\>= 18 years\n* Histological confirmed adenocarcinoma of the breast stage I-IV from the American Joint Committee on Cancer staging 8th edition\n* Any estrogen receptor (ER) or progesterone receptor (PR) but HER2 positive defined as per the most current American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guideline\n* Provide written informed consent\n* Willingness to provide blood samples for correlative research purposes\n* BLOOD AND TISSUE COHORT: Scheduled to start new anti-HER2 therapy\u002Ftherapies\n* TISSUE-ONLY COHORT: Received or previously completed anti-HER2 therapy\u002Ftherapies\n\nExclusion Criteria:\n\n* Immunocompromised patients including patients known to be human immunodeficiency virus (HIV) positive\n* Receiving systemic steroid therapy or any other immunosuppressive therapy =\\\u003C 30 days prior to registration. NOTE: Inhaled steroids, low-dose corticosteroids (e.g. equivalent to or less than oral prednisone 10 mg daily), and steroid use for primary prevention of nausea per institutional guidelines are allowed.",{"count":287,"type":20},230,"OBSERVATIONAL","This study gathers information from the blood cells and tumor tissue during treatment with anti-HER2 therapies, such as trastuzumab, pertuzumab, lapatinib, or neratinib, in patients with HER2 positive stage I-IV breast cancer who are scheduled to start anti-HER2 therapy. The information gained from this study may help researchers better understand the relation between cell response and anti-HER2 therapies.",[291,292,78,26,55,207],"Breast Adenocarcinoma","HER2-Positive Breast Carcinoma",{"date":228,"type":35},{"date":295,"type":35},"2020-07-31",{"date":297,"type":20},"2028-07-27",{"name":256,"class":89},{"id":300,"slug":4,"hasResults":11,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":304,"eligibilityCriteria":305,"healthyVolunteers":11,"sex":70,"minAge":242,"maxAge":4,"enrollmentInfo":306,"targetDuration":4,"studyType":21,"phases":308,"briefSummary":309,"conditions":310,"keywords":313,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":325,"locationsCount":90},"100425138","NCT04816006","Breast Cancer, Reasoning, and Activity Intervention","Enhancing Cognitive Function in Breast Cancer Survivors Through Community-based Exercise Training","BRAIN","Inclusion Criteria\n\n* PRE-REGISTRATION: Age ≥50 years at time of pre-registration visit according to participant report and\u002For clinical determination\n* PRE-REGISTRATION: First, primary diagnosis of stage I-IIIa breast cancer according to participant report and\u002For clinical determination\n* PRE-REGISTRATION: Post-surgery and completed primary treatment (i.e., surgery, chemotherapy, and\u002For radiation therapy) 3-36 months prior to registration according to participant report and\u002For clinical determination\n* PRE-REGISTRATION: Sedentary except for casual lifestyle recreation defined as self-reporting no more than 90 minutes per week of moderate-intensity aerobic exercise within the last 6 months\n* PRE-REGISTRATION: Self-reported ability to complete assessments by themselves or with assistance\n* REGISTRATION: Age ≥50 years as confirmed via clinical determination\n* REGISTRATION: Able to provide medical record release to confirm eligibility\n* REGISTRATION: First, primary diagnosis of stage I-IIIa breast cancer as confirmed via clinical determination\n* REGISTRATION: Post-surgery and completed primary treatment (i.e., surgery, chemotherapy, and\u002For radiation therapy) 3-36 months prior to pre-registration as confirmed via clinical determination\n* REGISTRATION: No evidence of possible cognitive impairment as assessed using the Telephone Interview of Cognitive status (13-item modified version) (TICS-M; score \\> 21) NOTE: Only individuals who pass the TICS-M during pre-registration will be invited to participate in the urine substudy\n* REGISTRATION: Receive physician's clearance to participate in an exercise program\n\nNOTE: Individuals with conditions\u002Fdiagnoses deemed important by the primary investigator will be required to provide clearance for exercise from their cardiologist. Example conditions include:\n\n* History of major multiple myocardial infarctions (MI)\n* Recent electrocardiogram (ECG) changes or recent MI\n* Resting or unstable angina\n* Significant multivessel coronary occlusion (≥ 70%) on angiography\n* Uncontrolled and\u002For serious arrhythmias\n* 3rd degree heart block\n* Acute congestive heart failure or ejection fraction \\\u003C 30%\n\n  * REGISTRATION: Ability to complete assessments by themselves or with assistance\n\nExclusion Criteria:\n\n* PRE-REGISTRATION: Stage 0 breast cancer diagnosis OR metastatic disease\n* PRE-REGISTRATION: Currently receiving or \\\u003C 3 months since receiving chemotherapy or radiation therapy for cancer, or greater than 36 months post primary treatment\n* PRE-REGISTRATION: Planned surgery during the intervention period\n* PRE-REGISTRATION: Second cancer diagnosis (excluding non-invasive skin cancers or carcinoma-in-situ for any cancer)\n* PRE-REGISTRATION: Unable to travel regularly to the study locations for intervention sessions and data collection\n* PRE-REGISTRATION: Unwilling to return to enrolling institution for follow-up\n* PRE-REGISTRATION: Self-reported inability to walk without assistance or devices\n* REGISTRATION: History of stroke, transient ischemic attack, other neurological disorders, or brain surgery involving tissue removal as confirmed via clinical determination\n* REGISTRATION: Clinically significant TICS-M score (\\\u003C 21) during baseline procedures\n* REGISTRATION: Not able to provide physician re-clearance for exercise if required based upon clinically significant baseline exercise test (as determined by ECG and blood pressure monitoring)\n* REGISTRATION: Contraindications to functional magnetic resonance imaging (fMRI) in accordance with the Mayo Clinic Department of Radiology safety protocols\n* REGISTRATION: Clinically significant MRI scan as determined by physician review in which the following is advised via radiologist overread: remarkable\u002Fabnormal limited diagnostic brain image with recommended medical follow-up\n* REGISTRATION: Enrolled in another physical activity program\n* REGISTRATION: Unable to walk without assistance or devices\n* REGISTRATION: Unwilling to complete study requirements\n* REGISTRATION: Unwilling to be randomized to the exercise group or health education group\n* REGISTRATION: Unable or unwilling to continuously wear and regularly sync\u002Fcharge an activity tracker during the study period\n* REGISTRATION: Unable to travel regularly to the study locations for intervention sessions and data collection\n* REGISTRATION: Unwilling to return to enrolling institution for follow-up",{"count":307,"type":20},160,[74],"This phase II trial tests whether an exercise intervention works to improve cognitive function in breast cancer survivors. Many breast cancer survivors report cancer-related cognitive impairment, which this has recently become a priority in clinical research due to its dramatic impact on daily functioning, quality of life, and long-term health. Aerobic exercise has the potential to improve cognitive function and brain health in older adults and is recommended as a safe, tolerable, and accessible complementary therapy for breast cancer survivors. This study aims to understand the effects of physical activity compared with health education on memory, attention, and brain health in women with breast cancer. Study findings may help researchers design more programs that can improve memory, attention, and brain health in other women with breast cancer.",[311,312,78,26,27,248],"Breast Cancer","Breast Neoplasms",[314,315,316,317,318],"physical activity","exercise","cognition","brain health","breast cancer","2026-06-11",{"date":272,"type":35},{"date":322,"type":35},"2024-02-22",{"date":324,"type":20},"2028-07-31",{"name":256,"class":89},{"id":327,"slug":4,"hasResults":11,"nctId":328,"briefTitle":329,"officialTitle":330,"acronym":4,"eligibilityCriteria":331,"healthyVolunteers":11,"sex":70,"minAge":17,"maxAge":4,"enrollmentInfo":332,"targetDuration":4,"studyType":21,"phases":334,"briefSummary":335,"conditions":336,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":338,"lastUpdatePostDateStruct":339,"startDateStruct":340,"completionDateStruct":342,"leadSponsor":344,"locationsCount":346},"100574749","NCT06763328","Metformin for the Treatment of Insulin Resistance in Women With Stage I-III Breast Cancer Completing Chemotherapy","Metformin (Dimethylbiguanide) and Insulin Resistance in Women Completing Neoadjuvant and\u002For Adjuvant Cytotoxic Treatment of Stage I-III Breast Cancer","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n* Agreement to allow lab draw of approximately 26 mL of blood (less than 2 tablespoons)\n\n  * To check blood counts, organ function and disease at baseline and 12 months\n  * Review of clinical charts at pre-registration\\* (refer to Study Calendar), baseline, 3 months, 6 months,12 months, and 24 months\n  * Research labs at baseline, 6 months,12 months, and 24 months\n* Age: ≥ 18 years\n* Female sex assigned at birth\n* Ability to read and understand English or Spanish for questionnaires\n* Diagnosis of invasive breast cancer stages I-III\n* Completed adjuvant treatment for Stage 1-3 breast cancer within 5 years and are disease free.\n* Women who receive drugs for weight loss - e.g. semaglutide - prior to diagnosis are eligible for this protocol and can continue the drug during the intervention.\n\nExclusion Criteria:\n\n* Currently taking metformin or any other oral antidiabetic medications. Weight loss medications are permitted - e.g. semaglutide\n* Taking tamoxifen or aromatase inhibitor\n* Contraindication to metformin prevention such as acute hypersensitivity or allergic reaction to metformin\n* Participants with acute or chronic renal insufficiency (a glomerular filtration rate \\[GFR\\] \\\u003C 60 mL\u002Fmin\u002F1.73m\\^2) or those with acute renal insufficiency of any severity due to hepato-renal syndrome or in the peri-operative liver transplantation period\n* Bilirubin of \\>2.5 mg\u002FdL (normal range 0.1-1.2 mg\u002FdL).\n* Previously diagnosed type 1 or type 2 diabetes\n* Patients pregnant or within 1 year of pregnancy and completion of lactation (to be determined at randomization).\n* Other active malignancy. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* An employee who is under the direct\u002Findirect supervision of the principal investigator (PI)\u002Fa co-investigator\u002Fthe study manager and\u002For a direct study team member\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)",{"count":333,"type":20},80,[23],"This phase III trial evaluates how often women develop insulin resistance and type-2 diabetes and compares metformin with usual care to usual care alone in treating insulin resistance in women with stage I-III breast cancer after chemotherapy. Insulin resistance occurs when cells stop responding to insulin and is a risk factor for developing diabetes and heart disease. Higher levels of insulin have been shown to be associated with aggressive breast cancer. Metformin hydrochloride decreases the amount of glucose (a type of sugar) released into the bloodstream from the liver and increases the body's use of the glucose. Metformin as well as standard of care diet and exercise education is known to lower blood sugar. However, chemotherapy may accelerate metabolic disorders, such as high blood sugar, and the impact of metformin in these breast cancer survivors is not known. Giving metformin with usual care may be more effective than usual care alone in preventing or reversing insulin resistance in women with stage I-III breast cancer after chemotherapy.",[78,26,55,337],"Invasive Breast Carcinoma","2026-06-10",{"date":272,"type":35},{"date":341,"type":35},"2024-12-16",{"date":343,"type":20},"2029-06-16",{"name":345,"class":89},"City of Hope Medical Center",3,{"id":348,"slug":4,"hasResults":11,"nctId":349,"briefTitle":350,"officialTitle":351,"acronym":352,"eligibilityCriteria":353,"healthyVolunteers":11,"sex":70,"minAge":17,"maxAge":4,"enrollmentInfo":354,"targetDuration":4,"studyType":21,"phases":356,"briefSummary":357,"conditions":358,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":360,"startDateStruct":362,"completionDateStruct":363,"leadSponsor":365,"locationsCount":90},"100506431","NCT05874297","Online Nutrition Education to Decrease the Side Effects of Chemotherapy in Patients With Breast Cancer","Feasibility and Pilot Study Testing an Online Digital Intervention to Improve Symptom Management During Breast Cancer Chemotherapy","ONE","Inclusion Criteria:\n\n* 18 years of age or older.\n* Stage I-III breast cancer.\n* Current breast cancer patients scheduled to receive ddAC-T(+\u002F-C), TCHP, or TCPembro-AC chemotherapy at Fred Hutch South Lake Union (can enroll prior to receipt of 2nd cycle).\n* Not pregnant and no plan to become pregnant during chemotherapy treatment.\n* Ability to speak and read English.\n* Access to smartphone, tablet, or computer and Internet.\n* Willing and able to complete all study activities through the end of chemotherapy, including completing online questionnaires and telephone assessments.\n* Women must not be pregnant at time of enrollment based on self-report.\n* Able to understand and willing to sign written informed electronic (e) consent in English.",{"count":355,"type":20},50,[74],"This trial tests an online nutrition education program focused on decreasing nutrition-related side effects of chemotherapy in patients with breast cancer. Patients undergoing chemotherapy are at risk for complications such as diarrhea or constipation which can lead to poor nutritional intake and malabsorption of nutrients. This study is testing the effects of information delivered via the Cook for Your Life website in conjunction with standard clinical care to improve symptom management during chemotherapy treatment for breast cancer, which could serve as a new model for supportive oncology care.",[78,26,55],"2026-06-04",{"date":361,"type":35},"2026-06-05",{"date":84,"type":20},{"date":364,"type":20},"2026-11-01",{"name":235,"class":89},{"id":367,"slug":4,"hasResults":11,"nctId":368,"briefTitle":369,"officialTitle":369,"acronym":4,"eligibilityCriteria":370,"healthyVolunteers":11,"sex":70,"minAge":17,"maxAge":4,"enrollmentInfo":371,"targetDuration":4,"studyType":288,"phases":4,"briefSummary":373,"conditions":374,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":380,"lastUpdatePostDateStruct":381,"startDateStruct":383,"completionDateStruct":385,"leadSponsor":387,"locationsCount":90},"100545914","NCT06388122","DiviTum®TKa: A Biomarker Assay for Efficacy in HR+ Breast Cancer Patients","Inclusion Criteria:\n\n* Pre- or post-menopausal HR+ metastatic breast cancer patients who are:\n\n  * Group 1: scheduled to initiate 1st line combination therapy with an FDA-approved CDK4\u002F6 inhibitor (palbociclib, ribociclib, or abemaciclib) and an FDA-approved endocrine therapy for pre- or post-menopausal HR+ metastatic breast cancer (mBC).\n  * Group 2: scheduled to initiate second or later lines of therapy with an FDA-approved CDK4\u002F6 inhibitor (palbociclib, ribociclib, or abemaciclib) with or without an FDA-approved endocrine therapy for pre- or post-menopausal HR+ mBC.\n  * Group 3: currently receiving 1st line therapy with an FDA-approved CDK4\u002F6 inhibitor (palbociclib, ribociclib, or abemaciclib) and an FDA-approved endocrine therapy for pre- or post-menopausal HR+ mBC.\n  * Group 4: scheduled to initiate, or are currently receiving, 1st or 2nd line therapy of an FDA approved endocrine therapy (single agent) for pre- or post-menopausal HR+ mBC.\n  * Group 5: scheduled to initiate or are currently receiving 1st line therapy of an FDA-approved CDK4\u002F6 inhibitor (ribociclib or abemaciclib) with an FDA approved endocrine therapy for stage 2 or stage 3 adjuvant HR+ BC\n\nNOTE: Patients that meet eligibility criteria for any of the above groups that are already enrolled in an ongoing clinical trial are eligible for co-enrollment to this observational study.\n\nExclusion Criteria:\n\n* Treatment including investigational agent or therapies\n* Early breast cancer diagnosis\n* Male breast cancer\n* Currently receiving treatment for other active malignancy at time of registration\n\n  * EXCEPTIONS: Nonmelanoma skin cancer or carcinoma-in-situ (e.g. of cervix, prostate)\n* Inability to give written informed consent",{"count":372,"type":20},100,"This study is being done to determine if there is a pattern associated with response to endocrine therapy alone and in combination with CDK4\u002F6 inhibitor used for hormone receptor positive HER2 negative breast cancer.",[375,376,377,26,55,207,378,379,208],"HER2-negative Breast Cancer","Hormone-receptor-positive Breast Cancer","Metastatic Breast Cancer","HER2 Negative Breast Carcinoma","Hormone Receptor Positive Breast Carcinoma","2026-05-28",{"date":382,"type":35},"2026-06-01",{"date":384,"type":35},"2024-04-30",{"date":386,"type":20},"2031-06-15",{"name":256,"class":89},{"id":389,"slug":4,"hasResults":11,"nctId":390,"briefTitle":391,"officialTitle":392,"acronym":4,"eligibilityCriteria":393,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":394,"enrollmentInfo":395,"targetDuration":4,"studyType":288,"phases":4,"briefSummary":397,"conditions":398,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":493,"lastUpdatePostDateStruct":494,"startDateStruct":495,"completionDateStruct":497,"leadSponsor":498,"locationsCount":174},"100612878","NCT07259304","Social Health, Activity Behaviors, and Quality of Life Among Young Adult Cancer Survivors","Social Health, Activity Behaviors, and Quality of Life Among Young Adult Cancer Survivors: A Longitudinal Study","Inclusion Criteria:\n\n* Diagnosed and\u002For treated with cancer between ages 18-39 at USC hospitals.\n* Cancer types prototypical for adolescents and young adults (AYAs) and cancer stages I-III; select patients with stage IV disease may be eligible, with approval by the principal investigator (PI) and in consultation with the treating clinician.\n* Must be within three months of a de novo cancer diagnosis at recruitment and on\u002Findicated for curative therapy (any modality). Patients may continue on adjuvant therapy throughout duration of the study.\n* Patients must have anticipated survival of \\>1-year at time of diagnosis.\n\nExclusion Criteria:\n\n* Diagnosis of blood malignancies such as leukemias (these cancers have divergent treatment patterns of longer duration than other cancers and are more commonly pediatric cancers). Some early stage lymphomas with favorable prognoses may be eligible, with approval by the PI and in consultation with the treating clinician.\n* Primary language other than English or Spanish.\n* Inability to complete a survey and\u002For wear an accelerometer either per the patient or in consultation with the clinician's judgment.","39 Years",{"count":396,"type":20},250,"This study assesses how personal relationships (such as friendships, family relationships, or romantic partners) influence the physical activity (exercise) and well-being of young adult cancer survivors. Researchers also hope to learn how social relationships change after a cancer diagnosis, and how these changes might impact important health behaviors. The information provided may help researchers learn more about better ways to support young cancer patients in the future through interventions that help maintain good social relationships and health levels of physical activity.",[78,399,400,26,401,402,55,27,145,28,403,404,405,406,407,408,409,410,411,412,413,414,415,416,417,418,419,420,421,422,423,424,425,426,427,428,429,430,431,432,433,434,435,436,437,438,439,440,441,442,443,444,445,446,447,448,449,450,451,452,453,454,455,456,457,458,459,460,461,462,463,464,465,466,467,468,469,470,471,472,473,474,475,476,477,478,479,480,481,482,483,484,485,486,487,488,489,490,491,492],"Anatomic Stage IA Breast Cancer AJCC v8","Anatomic Stage IB Breast Cancer AJCC v8","Anatomic Stage IIA Breast Cancer AJCC v8","Anatomic Stage IIB Breast Cancer AJCC v8","Central Nervous System Neoplasm","Clinical Stage I Cutaneous Melanoma AJCC v8","Clinical Stage IA Cutaneous Melanoma AJCC v8","Clinical Stage IB Cutaneous Melanoma AJCC v8","Clinical Stage II Cutaneous Melanoma AJCC v8","Clinical Stage IIA Cutaneous Melanoma AJCC v8","Clinical Stage IIB Cutaneous Melanoma AJCC v8","Clinical Stage IIC Cutaneous Melanoma AJCC v8","Clinical Stage III Cutaneous Melanoma AJCC v8","Hodgkin Lymphoma","Malignant Bone Neoplasm","Malignant Brain Neoplasm","Malignant Solid Neoplasm","Malignant Testicular Neoplasm","Non-Hodgkin Lymphoma","Pathologic Stage I Cutaneous Melanoma AJCC v8","Pathologic Stage IA Cutaneous Melanoma AJCC v8","Pathologic Stage IB Cutaneous Melanoma AJCC v8","Pathologic Stage II Cutaneous Melanoma AJCC v8","Pathologic Stage IIA Cutaneous Melanoma AJCC v8","Pathologic Stage IIB Cutaneous Melanoma AJCC v8","Pathologic Stage IIC Cutaneous Melanoma AJCC v8","Pathologic Stage III Cutaneous Melanoma AJCC v8","Pathologic Stage IIIA Cutaneous Melanoma AJCC v8","Pathologic Stage IIIB Cutaneous Melanoma AJCC v8","Pathologic Stage IIIC Cutaneous Melanoma AJCC v8","Pathologic Stage IIID Cutaneous Melanoma AJCC v8","Prognostic Stage I Breast Cancer AJCC v8","Prognostic Stage IA Breast Cancer AJCC v8","Prognostic Stage IB Breast Cancer AJCC v8","Prognostic Stage II Breast Cancer AJCC v8","Prognostic Stage IIA Breast Cancer AJCC v8","Prognostic Stage IIB Breast Cancer AJCC v8","Prognostic Stage III Breast Cancer AJCC v8","Prognostic Stage IIIA Breast Cancer AJCC v8","Prognostic Stage IIIB Breast Cancer AJCC v8","Prognostic Stage IIIC Breast Cancer AJCC v8","Stage I Cervical Cancer AJCC v8","Stage I Colorectal Cancer AJCC v8","Stage I Differentiated Thyroid Gland Carcinoma AJCC v8","Stage I Ovarian Cancer AJCC v8","Stage I Thyroid Gland Medullary Carcinoma AJCC v8","Stage I Uterine Corpus Cancer AJCC v8","Stage IA Cervical Cancer AJCC v8","Stage IA Ovarian Cancer AJCC v8","Stage IA Uterine Corpus Cancer AJCC v8","Stage IA1 Cervical Cancer AJCC v8","Stage IA2 Cervical Cancer AJCC v8","Stage IB Cervical Cancer AJCC v8","Stage IB Ovarian Cancer AJCC v8","Stage IB Uterine Corpus Cancer AJCC v8","Stage IB1 Cervical Cancer AJCC v8","Stage IB2 Cervical Cancer AJCC v8","Stage IC Ovarian Cancer AJCC v8","Stage II Cervical Cancer AJCC v8","Stage II Colorectal Cancer AJCC v8","Stage II Differentiated Thyroid Gland Carcinoma AJCC v8","Stage II Ovarian Cancer AJCC v8","Stage II Thyroid Gland Medullary Carcinoma AJCC v8","Stage II Uterine Corpus Cancer AJCC v8","Stage IIA Cervical Cancer AJCC v8","Stage IIA Colorectal Cancer AJCC v8","Stage IIA Ovarian Cancer AJCC v8","Stage IIA1 Cervical Cancer AJCC v8","Stage IIA2 Cervical Cancer AJCC v8","Stage IIB Cervical Cancer AJCC v8","Stage IIB Colorectal Cancer AJCC v8","Stage IIB Ovarian Cancer AJCC v8","Stage IIC Colorectal Cancer AJCC v8","Stage III Cervical Cancer AJCC v8","Stage III Colorectal Cancer AJCC v8","Stage III Differentiated Thyroid Gland Carcinoma AJCC v8","Stage III Ovarian Cancer AJCC v8","Stage III Thyroid Gland Medullary Carcinoma AJCC v8","Stage III Uterine Corpus Cancer AJCC v8","Stage IIIA Cervical Cancer AJCC v8","Stage IIIA Colorectal Cancer AJCC v8","Stage IIIA Ovarian Cancer AJCC v8","Stage IIIA Uterine Corpus Cancer AJCC v8","Stage IIIA1 Ovarian Cancer AJCC v8","Stage IIIA2 Ovarian Cancer AJCC v8","Stage IIIB Cervical Cancer AJCC v8","Stage IIIB Colorectal Cancer AJCC v8","Stage IIIB Ovarian Cancer AJCC v8","Stage IIIB Uterine Corpus Cancer AJCC v8","Stage IIIC Colorectal Cancer AJCC v8","Stage IIIC Ovarian Cancer AJCC v8","Stage IIIC Uterine Corpus Cancer AJCC v8","Stage IIIC1 Uterine Corpus Cancer AJCC v8","Stage IIIC2 Uterine Corpus Cancer AJCC v8","2026-05-26",{"date":380,"type":35},{"date":496,"type":35},"2021-11-24",{"date":86,"type":20},{"name":499,"class":89},"University of Southern California",{"id":501,"slug":4,"hasResults":11,"nctId":502,"briefTitle":503,"officialTitle":504,"acronym":4,"eligibilityCriteria":505,"healthyVolunteers":11,"sex":70,"minAge":17,"maxAge":4,"enrollmentInfo":506,"targetDuration":4,"studyType":288,"phases":4,"briefSummary":508,"conditions":509,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":493,"lastUpdatePostDateStruct":510,"startDateStruct":511,"completionDateStruct":513,"leadSponsor":515,"locationsCount":90},"100499700","NCT05786664","Breast Cancer Survivorship Biorepository","A Comprehensive Breast Cancer Survivorship Biorepository","Inclusion Criteria:\n\n* Women of all racial and ethnic groups 18 years of age or older\n* Women with a diagnosis of invasive breast cancer (stages I-III) within the past 7 years\n* Women who have completed active treatment for breast cancer (surgery, chemotherapy, HER2-directed therapy and radiation)\n* Prior participation on clinical trials is allowed\n\nExclusion Criteria:\n\n* Current receipt of interventional clinical trial participation\n* Stage IV (metastatic) cancer\n* Prior history of recurrence (except recurrence following ductal carcinoma in situ)\n* Inability to give informed consent\n* Unable to speak English, Spanish, Chinese, or Korean",{"count":507,"type":20},1300,"This study collects blood samples as well as clinical and self-report data from stage I-III breast cancer survivors to create a biorepository for future use. The creation of this biorepository will allow for future research into links between individual, molecular, and genomic signatures and cancer outcomes.",[78,26,55,337],{"date":380,"type":35},{"date":512,"type":35},"2022-04-11",{"date":514,"type":20},"2028-04-11",{"name":499,"class":89},{"id":517,"slug":4,"hasResults":11,"nctId":518,"briefTitle":519,"officialTitle":519,"acronym":4,"eligibilityCriteria":520,"healthyVolunteers":11,"sex":70,"minAge":17,"maxAge":4,"enrollmentInfo":521,"targetDuration":4,"studyType":288,"phases":4,"briefSummary":523,"conditions":524,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":526,"lastUpdatePostDateStruct":527,"startDateStruct":529,"completionDateStruct":531,"leadSponsor":533,"locationsCount":90},"100546970","NCT06401889","Enhancing Skin Appearance and Quality of Life in Breast Cancer Survivors on Aromatase Inhibitor Therapy","Inclusion Criteria:\n\n* \\* Female ≥ 18 years\n\n  * Postmenopausal women suitable to receive aromatase inhibitor as per physician's discretion\n  * Histologically confirmed adenocarcinoma of the breast stage 0-III with estrogen receptor (ER) and\u002For progesterone receptor (PR) positive per American Society of Clinical Oncology (ASCO)\u002F College of American Pathologists (CAP) guideline and any human epidermal growth factor receptor 2 (HER2)\n  * Patients must not have received any prior chemotherapy or endocrine therapy for their current breast cancer. Patients who received tamoxifen or raloxifene or another agent for prevention of breast cancer may be included\n  * Patients willing to avoid any facial procedures including facials, neurotoxin injections, fillers, or lasers during study period\n  * Willing and able to provide consent\n\nExclusion Criteria:\n\n* \\* Patients who have previously taken AIs\n\n  * Patients using prescription tretinoin, neurotoxin injections, fillers, facial lasers, microneedling, or facials within 6 months of study consent",{"count":522,"type":20},35,"This study evaluates changes in skin quality and self-esteem among breast cancer patients who are initiating aromatase inhibitor therapy.",[77,78,26,55,291,29,525],"Progesterone Receptor-Positive Breast Carcinoma","2026-05-18",{"date":528,"type":35},"2026-05-19",{"date":530,"type":35},"2024-07-19",{"date":532,"type":20},"2027-07-19",{"name":256,"class":89},{"id":535,"slug":4,"hasResults":11,"nctId":536,"briefTitle":537,"officialTitle":538,"acronym":4,"eligibilityCriteria":539,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":540,"targetDuration":4,"studyType":21,"phases":541,"briefSummary":542,"conditions":543,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":545,"lastUpdatePostDateStruct":546,"startDateStruct":547,"completionDateStruct":548,"leadSponsor":549,"locationsCount":90},"100640107","NCT07594678","Minoxidil With or Without Low-Level Red-Light Therapy for Improving Chemotherapy-Induced Alopecia in Breast Cancer Patients","A Pilot Study of Low-Level Red-Light Therapy Combined With Topical Minoxidil Compared With Topical Minoxidil Alone in Breast Cancer Patients With Chemotherapy-Induced Alopecia","Inclusion Criteria:\n\n* Patients will be Ohio State University patients \\> 18 years old\n* Patients will have a diagnosis of breast cancer, stages I-IV\n* Patients will have been treated with a chemotherapy regimen containing either an anthracycline or taxane\n* Patients will have a loss of at least 50% of the hair on the scalp by the final chemotherapy infusion\n* Patients will NOT be pregnant or nursing women\n* Patients will NOT have a history of scarring\u002Fcicatricial alopecia or alopecia areata\n* Patients will NOT have a known sensitivity to minoxidil\n* Patients will NOT have ongoing treatment with an antibody-drug conjugate or immunotherapy\n* NOTE: There is no exclusion criteria for utilization of scalp cooling",{"count":355,"type":20},[184],"This phase II trial compares the safety and effectiveness of topical minoxidil alone to topical minoxidil in combination with low-level red-light therapy for improving chemotherapy-induced hair loss or thinning (alopecia). Minoxidil has been approved by the Food and Drug Administration as a treatment for hair loss. It increases blood flow in the skin and may have a direct stimulatory effect on hair follicle cells, forcing them from their resting phase into their active growth phase. Low-level light therapy is regarded as a safe and medically accepted treatment for a variety of skin conditions, including acne, scars, and psoriasis. Red light wavelengths are readily absorbed into the skin and do not contain harmful ultraviolet light. When absorbed into the skin, these wavelengths stimulate fibroblasts, which are connective tissue cells that make and secrete collagen proteins. Low-level red-light therapy may improve hair loss by stimulating hair follicles. Combining minoxidil with low-level red-light therapy may be safe and more effective at improving chemotherapy-induced alopecia than minoxidil alone.",[78,26,55,207,544],"Chemotherapy-Induced Alopecia","2026-05-15",{"date":528,"type":35},{"date":98,"type":20},{"date":86,"type":20},{"name":88,"class":89},{"id":551,"slug":4,"hasResults":11,"nctId":552,"briefTitle":553,"officialTitle":554,"acronym":4,"eligibilityCriteria":555,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":556,"targetDuration":4,"studyType":21,"phases":557,"briefSummary":558,"conditions":559,"keywords":560,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":545,"lastUpdatePostDateStruct":562,"startDateStruct":563,"completionDateStruct":565,"leadSponsor":566,"locationsCount":90},"100387771","NCT04329065","Concurrent WOKVAC Vaccination, Chemotherapy, and HER2-Targeted Monoclonal Antibody Therapy Before Surgery for the Treatment of Patients With Breast Cancer","A Phase II Study of Concurrent WOKVAC Vaccination With Neoadjuvant Chemotherapy and HER2-Targeted Monoclonal Antibody Therapy","Inclusion Criteria:\n\n* Patients must be at least \\>= 18 years of age\n* Clinical stage I-III breast cancer, HER2+ (per American Society of Clinical Oncology \\[ASCO\\]\u002FCollege of American Pathologists \\[CAP\\] guideline update, 2018), regardless of estrogen receptor (ER)\u002F progesterone receptor (PR) status and planning to undergo neoadjuvant therapy with either paclitaxel, trastuzumab, and pertuzumab (THP) or docetaxel, carboplatin, trastuzumab, and pertuzumab (TCHP)\n* Patients who have received prior neoadjuvant chemotherapy are allowed but may only receive paclitaxel, trastuzumab, and pertuzumab for the duration the study\n* Subjects with Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1\n* White blood cell (WBC) \\>= 3000\u002Fmm\\^3 (within 4 weeks of initiating study treatment)\n* Lymphocyte count \\>= 500\u002Fmm\\^3 (within 4 weeks of initiating study treatment)\n* Absolute neutrophil count (ANC) \\>= 1,500\u002F uL (within 4 weeks of initiating study treatment)\n* Platelets \\>= 75,000\u002F uL (within 4 weeks of initiating study treatment)\n* Total bilirubin =\\\u003C 1.5 x institutional upper limit of normal (ULN), except patients with Gilbert's syndrome in whom total bilirubin must be \\\u003C 3.0 mg\u002FdL (within 4 weeks of initiating study treatment)\n* Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) =\\\u003C 3 x institutional upper limit of normal (ULN) (within 4 weeks of initiating study treatment)\n* Creatinine =\\\u003C 2.0 mg\u002FdL or creatinine clearance \\> 30 ml\u002Fmin (within 4 weeks of initiating study treatment)\n* Left ventricular ejection fraction (LVEF) \\>= lower limit of normal for institution performing the multi-gated acquisition (MUGA) or echocardiogram (ECHO) done within 3 months of initiating study treatment\n* Female patients of child-bearing potential must agree to use dual methods of contraception and have a negative urine pregnancy test at screening, and male patients must use an effective barrier method of contraception if sexually active with a female of child-bearing potential. Acceptable methods of contraception are condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or post-menopausal. For both male and female patients, effective methods of contraception must be used throughout the study and for three months following the last vaccine\n* Ability to understand and willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Patients with any of the following cardiac conditions:\n\n  * Symptomatic restrictive cardiomyopathy\n  * Dilated cardiomyopathy\n  * Unstable angina within 4 months prior to enrollment\n  * New York Heart Association functional class III-IV heart failure on active treatment\n  * Symptomatic pericardial effusion\n* Uncontrolled autoimmune disease requiring active systemic treatment\n* Known hypersensitivity reaction to the granulocyte-macrophage colony stimulating factor (GM-CSF) adjuvant; any known contra-indication to GM-CSF\n* Pregnant or breast feeding\n* Known human immunodeficiency virus (HIV)-positive\n* History of uncontrolled diabetes\n* Known current or a history of hepatitis B or C virus, including chronic and dormant states, unless disease has been treated and confirmed cleared\n* Major surgery within the 4 weeks prior to initiation of study vaccine\n* Current use of immunosuppressive agents or systemic corticosteroids. Topical, ocular, intra-articular, intranasal, inhalational corticosteroids (with minimal systemic absorption) are allowed. Patients who have received systemic corticosteroids =\\\u003C 30 days prior to starting study drug will be excluded\n\n  \\* NOTE: Steroids given as supportive care for the neoadjuvant chemotherapy regimens is allowable per standard of care\n* Patient is currently enrolled in any other clinical protocol or investigational trial that involves administration of experimental therapy and\u002For therapeutic devices, or investigational drug\n* Patients may not be receiving any other investigational agents",{"count":7,"type":20},[184],"This phase II trial studies the immunologic response and side effects of using the WOKVAC vaccine in combination with chemotherapy and HER2-targeted monoclonal antibody therapy before surgery in treating patients with breast cancer. Vaccines like WOKVAC are made from tumor-associated antigens which may help the body build an effective immune response to kill tumor cells. Chemotherapy drugs, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Trastuzumab and pertuzumab are forms of targeted therapy because they work by attaching themselves to specific molecules (receptors) on the surface of tumor cells, known as HER2 receptors. When trastuzumab and pertuzumab attach to HER2 receptors, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Giving the WOKVAC vaccine at the same time (concurrently) with paclitaxel, trastuzumab, and pertuzumab before surgery may kill more tumor cells.",[78,26,55],[561],"Breast",{"date":528,"type":35},{"date":564,"type":35},"2022-04-20",{"date":86,"type":20},{"name":567,"class":89},"University of Washington",{"id":569,"slug":4,"hasResults":11,"nctId":570,"briefTitle":571,"officialTitle":572,"acronym":4,"eligibilityCriteria":573,"healthyVolunteers":11,"sex":70,"minAge":574,"maxAge":4,"enrollmentInfo":575,"targetDuration":4,"studyType":21,"phases":576,"briefSummary":577,"conditions":578,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":580,"lastUpdatePostDateStruct":581,"startDateStruct":583,"completionDateStruct":585,"leadSponsor":587,"locationsCount":174},"100468390","NCT05379153","Testing Laser Therapy for Treatment of Vaginal Dryness in Survivors of Breast Cancer, The Revitalize Trial","The Revitalize Trial: Reducing Vaginal Atrophy With Fractional CO2 Laser for Breast Cancer Survivors","Inclusion Criteria:\n\n* Women with a history of breast cancer treated with curative intent who have completed primary therapy (consisting of surgery with or without chemotherapy, targeted therapy, immunotherapy and\u002For radiation) \\>= 12 months prior to registration. Concurrent trastuzumab \u002Fpertuzumab is permissible\n* May be receiving ongoing adjuvant endocrine therapy (with an AI or tamoxifen +\u002F- ovarian function suppression). Patients are not required to receive these treatments to be eligible. Participants receiving adjuvant endocrine therapy prior to registration must intend to continue the same endocrine therapy for the 4 months while they are receiving protocol treatment, unless a clinically necessary change is indicated at the discretion of the patient's medical oncologist. Patients on aromatase inhibitor (AI) therapy, tamoxifen with or without ovarian function suppression therapy must have been on their current endocrine therapy regimen for at least 6 months prior to registration\n* Patient-reported vaginal dryness with or without dyspareunia of at least moderate severity on average, defined as \\>= 4 on a 0-10-point scale that has been bothersome for \\>= 3 months and for which the patient wants to undergo the study procedure\n* No evidence of metastatic breast cancer. Scans to assess for metastatic disease are not required for eligibility\n* No prior gynecologic cancer, vaginal intra-epithelial neoplasia, pelvic radiation or pelvic reconstructive surgery utilizing mesh. Patients with cervical intraepithelial neoplasia are eligible\n* No history of scleroderma, lupus, systemic sclerosis, mixed connective tissue disorder, undifferentiated connective tissue disorder or collagen vascular disease, dermatomyositis, polymyositis, lichen sclerosis or vulvar vestibulitis\n* No pelvic surgery that involved a vaginal incision within 6 months of registration. Patients who received laparoscopic BSO (Bilateral salpingooophorectomy) are eligible\n* No systemic estrogen or progesterone, vaginal estrogen, vaginal prasterone, ospemifene, and\u002For androgen therapy within 6 weeks prior to registration\n* No other suspected contraindications for undergoing laser therapy\n* No prior vaginal laser therapy at any time. Patients who would have completed any type of vaginal laser resurfacing procedure at any time prior to the start of study treatment are not eligible\n* No known concurrent invasive carcinoma\u002Fmalignancy. Patients with carcinoma in situ are eligible. Patients with a prior malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible if not currently receiving treatment\n* Postmenopausal based on at least one of the following criteria at the time of registration:\n\n  * Women 50 or older with no spontaneous regular menses \\> 12 months\n  * On ovarian suppression (i.e., gonadotrophin releasing hormone \\[GNRH\\] agonist\u002Fantagonist) for at least 6 months or greater, with plans to continue such treatment for at least 18 weeks\n  * Bilateral oophorectomy\n  * Women on AI therapy (i.e., clinically judged to be postmenopausal)\n* In order to complete the mandatory patient-completed measures, participants must be able to speak, read and understand English or Spanish\n* Age \\>= 22 years\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* No medical history of: keloid formation, genital fistula, thin recto-vaginal septum (defined as a distance of \\\u003C 2 cm between the vaginal opening and the anal opening)","22 Years",{"count":396,"type":20},[23],"This phase III trial tests whether vaginal fractional CO2 laser therapy works in treating vaginal dryness in breast cancer survivors. Vaginal dryness can be commonly experienced with normal aging, with menopause, or come about from medications used to treat breast cancer such as chemotherapy or endocrine therapies like tamoxifen or aromatase inhibitors. Vaginal fractional CO2 laser therapy may help reduce vaginal dryness.",[77,78,399,400,26,401,402,55,27,145,28,579],"Vaginal Atrophy","2026-05-07",{"date":582,"type":35},"2026-05-11",{"date":584,"type":35},"2026-04-21",{"date":586,"type":20},"2027-05",{"name":121,"class":89},{"id":589,"slug":4,"hasResults":11,"nctId":590,"briefTitle":591,"officialTitle":592,"acronym":4,"eligibilityCriteria":593,"healthyVolunteers":11,"sex":70,"minAge":17,"maxAge":4,"enrollmentInfo":594,"targetDuration":4,"studyType":21,"phases":595,"briefSummary":596,"conditions":597,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":599,"lastUpdatePostDateStruct":600,"startDateStruct":602,"completionDateStruct":604,"leadSponsor":606,"locationsCount":90},"100557459","NCT06538389","High Cannabidiol Plant Extract (BRC-001) to Improve Aromatase Inhibitor-Induced Arthralgia in Women With Breast Cancer","High Cannabidiol (CBD) Standardized Extract for Aromatase Inhibitor-Induced Arthralgia - A Randomized Controlled Double Blind Clinical Trial","Inclusion Criteria:\n\n* Documented informed consent of the participant\n* Age: ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) ≤ 2\n* Postmenopausal by last menses \\> 12 months or medically induced menopause in premenopausal women for AI therapy use\n* At least 5 years since other malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or adequately treated stage I or II cancer from which the patient is currently in complete remission\n* Ability to read and understand English, Spanish, or translations by interpreters for questionnaires\n* Histologically confirmed primary invasive adenocarcinoma of the breast or ductal carcinoma in situ of the breast\n\n  * Stage 0, I, II, or IIIA disease\n  * No metastatic disease\n* Must have undergone definitive breast cancer surgery and recovered\n* Must have completed adjuvant chemotherapy as applicable, including systemic chemotherapy, anti-HER2 therapy, and\u002For radiation therapy\n* Estrogen-receptor positive (ER+) and\u002For progesterone-receptor positive (PR+)\n* Currently taking a third-generation aromatase inhibitor (AI) (e.g., anastrozole \\[Arimidex (registered trademark)\\], letrozole \\[Femara (registered trademark)\\], or exemestane \\[Aromasin (registered trademark)\\]) for ≥ 90 days prior to registration with plans to continue for ≥ 180 days after registration\n* Must have a worst pain\u002Fstiffness of ≥ 4 on the Brief Pain Inventory (BPI) (item #2) that has started or increased with AI therapy\n\nExclusion Criteria:\n\n* \\\u003C 3 months since prior cannabinoid containing cannabis or hemp products including CBD, tetrahydrocannabinol (THC), Marinol, and Epidiolex and must agree to refrain from use from sources outside of this study\n* \\\u003C 28 days since prior investigational agents\n* Medical therapy, alternative therapy, or physical therapy for joint pain\u002Fstiffness within the past 30 days\n* Narcotic use within 14 days of registration\n* Patients may have received corticosteroid treatment; however, the following criteria apply:\n\n  * Patients must not have received oral or intramuscular corticosteroids within 28 days prior to registration\n  * Patients must not have received intra-articular steroids to the study, or any other, joint within 28 days prior to registration\n* Patients must not have received topical analgesics (e.g., capsaicin preparations) to the study joint or any other analgesics (e.g., opiates, tramadol; with exception of nonsteroidal anti-inflammatory drugs \\[NSAIDs\\] and acetaminophen) within 14 days prior to registration\n* History of bone fracture or surgery of the afflicted hands, knees, and\u002For other joints within 6 months prior to registration\n* Any uncontrolled illness including ongoing or active infection\n* Known allergies or contraindications to cannabis\n* Significantly impaired hepatic function (alanine aminotransferase \\[ALT\\] \\> 5 x upper limit of normal \\[ULN\\] or total bilirubin \\[TBL\\] \\> 2 x ULN) OR the ALT or aspartate aminotransferase (AST) \\> 3 x ULN and TBL \\> 2 x ULN (or international normalized ratio \\[INR\\] \\> 1.5\n* Grade 3+ renal impairment\n* Clinically significant lab abnormalities in ALT, AST, total bilirubin, hemoglobin, hematocrit, or creatinine or any other laboratory tests that in the opinion of the investigator would prevent the patient from safely participating in the study\n* Having current thoughts of suicide or self-harm or history of suicidal ideation or attempted suicide\n* Meeting Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V) criteria for current major psychiatric illness, such as bipolar disorder, major depression, or psychosis (including schizophrenia and affective psychosis)\n* History of seizure disorder\n* Concomitant administration with drugs that may interact adversely with CBD including warfarin, theophylline, amiodarone, anti-epileptic (e.g., clobazam, stiripentol, valproate, topiramate), anticonvulsant (e.g., diazepam, lamotrigine, phenytoin, ethosuximide, oxcarbazepine, pregabalin, tigabine, gabapentin); 3) barbiturate (e.g., phenobarbital, hexobarbital), benzodiazepine (e.g, chlordiazepoxide, clonazepam), opioid\u002Fnarcotic (e.g, codeine, morphine)\n* Concomitant administration of cyclin-dependent kinase 4\u002F6 inhibitors, such as abemaciclib, with AI therapy\n* Following a physical examination, the patient has any abnormalities that, in the opinion of the investigator would prevent the patient from safely participating in the study\n* Other active malignancy\n* Any other condition or medication use that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Participants unwilling to abstain from donation of blood during the study\n* Participants who plan to travel outside of the United States during the study period\n* Women with childbearing potential are not eligible to participate. The study is for postmenopausal women taking aromatase inhibitors for adjuvant endocrine therapy\n* Participants with cognitive impairment are excluded due to dose titration instructions and completion of questionnaires\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)",{"count":102,"type":20},[184],"This phase II trial tests the effectiveness of cannabidiol (CBD) plant extract (BRC-001) in improving joint stiffness and pain (arthralgia) in women with breast cancer taking aromatase inhibitors (AIs). AIs lower blood levels of estrogen in postmenopausal women to reduce breast cancer recurrence. Women on AI therapy may experience joint stiffness, pain and arthritis symptoms as a side effect of the medication. Some women stop AI therapy due to these side effects and do not receive the maximum benefit from the medication. CBD is derived from the same plant family as marijuana but is not associated with a \"high\" or mind-altering effect and is not habit-forming. Research in animals and humans indicates that CBD might decrease inflammation in joint tissues and may help reduce chronic pain in ailments such as arthritis. BRC-001 may reduce joint pain in women with breast cancer taking AIs.",[77,78,26,27,291,598,29,525],"Breast Ductal Carcinoma In Situ","2026-04-27",{"date":601,"type":35},"2026-04-30",{"date":603,"type":35},"2024-08-26",{"date":605,"type":20},"2027-01-24",{"name":345,"class":89},""]