[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"early-stage-triple-negative-breast-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:early-stage-triple-negative-breast-carcinoma":289},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,42,66,92,118,148,195,238,260],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100501711",false,"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","ALL","18 Years",{"count":18,"type":19},1295,"ESTIMATED","INTERVENTIONAL",[22],"PHASE3","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.",[25,26,27,28],"Anatomic Stage II Breast Cancer AJCC v8","Early Stage Triple-Negative Breast Carcinoma","Anatomic Stage IIIA Breast Cancer AJCC v8","Anatomic Stage IIIB Breast Cancer AJCC v8","RECRUITING","2026-07-01",{"date":32,"type":33},"2026-07-02","ACTUAL",{"date":35,"type":33},"2023-06-14",{"date":37,"type":19},"2033-05-31",{"name":39,"class":40},"Alliance for Clinical Trials in Oncology","OTHER",842,{"id":43,"slug":4,"hasResults":10,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":20,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":65},"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":49,"type":19},120,[51],"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.",[54,25,55,26],"Anatomic Stage I Breast Cancer AJCC v8","Early Stage HER2-Positive Breast Carcinoma","2026-06-23",{"date":58,"type":33},"2026-06-24",{"date":60,"type":33},"2025-10-09",{"date":62,"type":19},"2027-09-30",{"name":64,"class":40},"M.D. Anderson Cancer Center",1,{"id":67,"slug":4,"hasResults":10,"nctId":68,"briefTitle":69,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":20,"phases":73,"briefSummary":74,"conditions":75,"keywords":78,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":91},"100635399","NCT07552181","Phase II Trial of Pembrolizumab\u002FChemotherapy With Live Biotherapeutic Product MO-03 in Patients With Early Stage Triple Negative Breast Cancer","Inclusion Criteria:\n\n* Female or male age ≥ 18 years of age.\n* Patients with high-risk early stage triple negative breast cancer. Triple negative status will be defined as ER≤10%, PR≤10%, HER2 negative (by FISH) per ASCO-CAP guidelines.\n* Clinically staging T1c any N M0 or any T N1-3 M0.\n* Willing to provide FFPE from baseline standard of care biopsy and post-treatment residual tumor at the time of surgery.\n* ECOG 0-1\n* Patients must have adequate organ function as defined in the following. Specimens must be collected within 28 days prior to the start of study treatment.\n* For patients who will receive regimen 1 only: Participants must have adequate cardiac function. Participants must have left ventricular ejection fraction ≥ 50% as assessed by either ECHO or MUGA within 28 days prior to the start of treatment. 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 and must be class 2B or better.\n* Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test within 28 days of the start of treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n* Male participants: A male participant must agree to use a contraception as detailed in Appendix B of this protocol during the treatment period and for at least 120 days after the last dose of MO-03 and refrain from donating sperm during this period.\n* Female participants: A female participant is eligible to participate if she is not pregnant (see Appendix B), not breastfeeding, and at least one of the following conditions applies:\n\n  i. Not a woman of childbearing potential (WOCBP) as defined in Appendix B OR ii. Females of child-bearing potential must be willing to use effective contraception during study and for 120 days after the last dose of MO-03.\n* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.\n\nExclusion Criteria:\n\n* Participants with known human immunodeficiency virus (HIV) infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to registration.\n* Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to registration, if indicated.\n\nNote: No testing for Hepatitis B is required unless mandated by local health authority.\n\n* Participant must not have uncontrolled diabetes or hypertension in the opinion of treating investigator.\n* Participant must not have had a major surgery within 14 days prior to screening.\n* Participant must not have severe infection within 14 days prior to enrollment.\n* Prohibited Treatments and\u002For Therapies:\n\n  * Any prior chemotherapy, biological therapy, immunotherapy for the current breast cancer diagnosis prior to start of study intervention\n  * Prior use of immune checkpoint inhibitor is prohibited\n  * Prior breast surgery or radiation therapy for current invasive breast cancer\n  * Participants must not have a diagnosis of immunodeficiency and be receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to enrollment.\n  * Participants must not have active autoimmune disease that has required systemic treatment in 2 years prior to enrollment (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroidreplacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.\n  * Participants must not have a history of (non-infectious) pneumonitis that required steroids or has current (non-infectious) pneumonitis.\n  * Any live vaccine within 30 days prior to the first dose of study drug and for 3 months after chemo-immunotherapy. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.\n  * Participants on any dose of warfarin. Use of low molecular weight heparin, antithrombin agents, anti-platelet agents or factor Xa inhibitors is allowed\n  * Participants may not use any other live biotherapeutic products (LBP) or supplementary use of probiotics in pill form during their participation in the study (e.g., Ferring's Rebyota, Vowst)\n* Participants may not be currently participating in or participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.\n* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.\n* Known allergy to any of the components within the study agents and\u002For their excipients (i.e., corn starch, lactose, microcrystalline cellulose, croscarmellose sodium or magnesium stearate).\n* Medical history and concurrent diseases:\n\n  * Any prior malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for at least five years\n  * Known active CNS metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (Note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention\n  * History of (non-infectious) pneumonitis that required steroids or has current pneumonitis\n  * Known history of active TB (Mycobacterium tuberculosis)\n* Intercurrent or historic medical condition that increases subject risk in the opinion of the Investigator. Eligibility may be revisited for intercurrent medical conditions once resolution\u002Frecovery is deemed adequate by the investigator (e.g., recovery from major surgery, completion of treatment for severe infection).\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n* Has had an allogenic tissue\u002Fsolid organ transplant.",{"count":72,"type":19},50,[51],"This is a single-arm and single site phase II trial combination of chemotherapy and pembrolizumab with LBP MO-03 in 50 trial participants with early triple negative breast cancer. MO-03 will be given at a dose of 4 x 10e9 CFU per capsule, 1 capsule taken orally twice daily. Patients will receive standard of care pembrolizumab 200 mg every 3 weeks in concurrent with a regimen of chemotherapy. Please refer to Table 2 for a summary of the chemo-immunotherapy with pembrolizumab containing regimens. Patients will continue to take MO-03 up until the day prior to surgery (lumpectomy or mastectomy). Post-surgery, patients will come in for a 2-week follow-up and then enter survival follow-up annually for 5 years.",[76,77,26],"TNBC - Triple-Negative Breast Cancer","TNBC",[79,80,77,81],"Pembrolizumab","Neoadjuvant Chemo-Immunotherapy","High-risk early stage TNBC","NOT_YET_RECRUITING","2026-06-19",{"date":58,"type":33},{"date":86,"type":19},"2026-09",{"date":88,"type":19},"2035-09",{"name":90,"class":40},"Yuan Yuan",3,{"id":93,"slug":4,"hasResults":10,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":98,"targetDuration":4,"studyType":20,"phases":100,"briefSummary":101,"conditions":102,"keywords":103,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":117},"100594302","NCT07017673","Phase II Trial of Ivonescimab in Combination With Carboplatin + Docetaxel in Patients With Early-Stage Triple Negative Breast Cancer","Phase II Trial of Ivonescimab in Combination With Carboplatin + Docetaxel in Patients With Early Stage Triple Negative Breast Cancer","Inclusion Criteria\n\n* Age ≥ 18 years of age\n* ECOG ≤ 1\n* High-risk early stage triple negative breast cancer (TNBC), defined by ER≤10%, PR≤10% and HER2 negative (by IHC or FISH), per ASCO\u002FCAP guidelines\n* Clinically ≥T1cN0, or any T, N1-2\n* Plan to receive neoadjuvant chemotherapy and immune checkpoint inhibitor before surgery as standard-of-care treatment\n* Adequate organ function as defined in the following. Specimens must be collected within 14 days prior to the start of study treatment.\n\n  * ANC ≥ 1,500\u002Fmm3\n  * Platelets ≥ 100,000\u002Fmm3\n  * Hemoglobin ≥ 9.0 g\u002FdL.\n  * Total serum bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels \\>1.5 x ULN\n  * AST \\\u003C 3 x ULN\n  * ALT \\\u003C 3 x ULN\n  * Creatinine clearance ≥ 30 mL\u002Fmin\n  * INR or PT, aPTT \\\u003C 1.5 x ULN\n* Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test within 14 days of start of study treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Note: If egg harvesting was completed prior to enrollment, the pregnancy test may be falsely positive and the PI will assess and determine eligibility for these cases.\n* Female participants: A female participant is eligible to participate if she is not pregnant (see Appendix B), not breastfeeding, and at least one of the following conditions applies:\n\n  \\-- Not a woman of childbearing potential (WOCBP) as defined in Appendix B OR Females of child-bearing potential must be willing to use effective contraception during study and for 120 days after the last dose.\n* Male participants: A male participant must agree to use a contraception as detailed in Appendix B of this protocol during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period.\n* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.\n\nExclusion Criteria\n\n* Evidence of metastatic disease.\n* Is currently participating in or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.\n* History of bleeding tendencies or coagulopathy and\u002For clinically significant bleeding symptoms or risk within 4 weeks prior to start of study treatment, including but not limited to:\n\n  * Hemoptysis (defined as coughing up ≥ 0.5 teaspoon of fresh blood or small blood clots) Note: transient hemoptysis associated with diagnostic bronchoscopy is allowed.\n  * Nasal bleeding\u002Fepistaxis (bloody nasal discharge is allowed)\n  * Current use of prophylactic or full-dose anticoagulants or anti-platelet agents for therapeutic purposes that is not stable, in the opinion of the treating investigator, prior to start of study treatment is not allowed. The use of full-dose anticoagulants is permitted as long as the INR or activated partial thromboplastin time (aPTT) is within therapeutic limits according to the medical standard of the enrolling institution.\n* Poorly controlled hypertension with repeated systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg after oral antihypertensive therapy\n* Women who are or are planning to become pregnant or breastfeed\n* Known allergy to any of the components within the study agents and\u002For their excipients\n* Medical history and concurrent diseases\n\n  * Autoimmune diseases\n  * Any prior malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for at least three years\n  * History of (non-infectious) pneumonitis that required steroids or has current pneumonitis\n  * Active infection requiring systemic therapy\n  * Known history of Human Immunodeficiency Virus (HIV) infection\n  * Known history of active Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority\n  * Known history of active TB (Mycobacterium tuberculosis)\n  * History of unstable angina, myocardial infarction, congestive heart failure (New York Heart Association \\[NYHA\\] classification ≥ grade 2) or unstable vascular disease (eg, aortic aneurysm at risk of rupture, Moyamoya disease) that required hospitalization within 12 months prior to randomization, or other cardiac impairment that may affect the safety evaluation of the study drug (eg, poorly controlled arrhythmias, myocardial ischemia)\n  * Prolongation of QTc interval \\>480 msec\n  * Prior allogeneic bone marrow transplantation or prior solid organ transplantation\n  * History of esophageal gastric varices, severe ulcers, wounds that do not heal, abdominal fistula, intra-abdominal abscesses, or acute gastrointestinal bleeding within 6 months prior to start of study treatment\n  * History of any grade arterial thromboembolic event, Grade 3 and above venous thromboembolic event, as specified in National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 12 months prior to start of study treatment\n  * Acute exacerbation of chronic obstructive pulmonary disease within 4 weeks before start of study treatment\n  * History of perforation of the gastrointestinal tract and\u002For fistula, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection) within 6 months prior to start of study treatment\n* Prohibited Treatments and\u002For Therapies\n\n  * Other non-protocol specified anti-cancer therapy: systemic radiotherapy, immunotherapy, biologic, or hormonal therapy. tretinoin therapy, nitrosourea, mitomycin C, small molecule tyrosine kinase inhibitor therapy\n\n    \\--- Concomitant use of hormones for non-tumor-related conditions (e.g., insulin and hormone replacement therapy for diabetes mellitus) is acceptable\n  * Any live vaccine within 30 days prior to the first dose of study drug and up to 120 days after the last dose. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed\n  * Prior systemic therapy or radiation therapy with curative intent for the current breast cancer\n  * A previous definitive ipsilateral breast surgery for the current breast cancer\n  * Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. CTLA-4, OX-40, CD137).\n  * Immunosuppressive drugs, including, but not limited to, prednisone or equivalent, methotrexate, azathioprine, and TNF-α antagonists at doses exceeding 10 mg per day. The following exceptions are allowed:\n\n    * The use of immunosuppressive drugs for the treatment of study drug-associated AEs or the use of immunosuppressive drugs in subjects with contrast allergy is acceptable.\n    * The use of inhaled, topical, and intranasal glucocorticoids is permitted.\n    * Corticosteroids are allowed as a prophylactic drug for hypersensitivity reactions (eg, before CT or MRI).\n    * Corticosteroids are allowed as antiphylactic and therapeutic agents for chemotherapy-induced vomiting.\n    * Short-term use of glucocorticoids for underlying or intercurrent conditions may be permitted after discussion with the PI.\n* Major surgery within 28 days prior to start of study treatment and within 4 weeks after first dose. Participants must have fully recovered from the effects of prior major surgery in the opinion of the treating investigator.\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.",{"count":99,"type":19},34,[51],"This is a single arm phase II trial combination of ivonescimab and carbo-docetaxel every 3 weeks for 6 cycles in patients with early-stage triple negative breast cancer. The trial is designed to test the safety and efficacy of adding ivonescimab in patients with early TNBC undergoing neoadjuvant chemotherapy with carboplatin and docetaxel. Patients will receive ivonescimab 20 mg\u002Fkg IV on Day 1 of each cycle, and carboplatin AUC6 and docetaxel 75 mg\u002Fm2 on Day 1 of each cycle for 6 cycles. Cycles will be 21 days for a total of 6 cycles. Curative intent surgery will be performed within 6 weeks (maximum 12 weeks) time frame upon completion of last dose of chemoimmunotherapy. The surgical pathology information will be used for assessment of pathological response, which serve as the primary endpoint of this study. Patients will undergo assessment at baseline, C1D1 of each cycle and end of treatment visit for collection of treatment-emergent adverse events, evaluated by CTCAE v5.0. Patient reported outcomes will be collected at cycles 1, 4, and 6, and at EOT. All study patients will be followed for at least 5 years for EFS and OS follow up. Research biopsies, peripheral blood and stool samples will be collected at the following time points: baseline, C4D1 (+\u002F-14 days), and surgery (+\u002F-14 days). Baseline and EOT breast MRI will be performed as standard of care for assessment of clinical response. Mid treatment breast ultrasound (C4D1 +\u002F-14 days) will be repeated as standard of care to assess clinical response to treatment. Mid-treatment C4D1 tumor biopsy may be omitted if the primary tumor is no longer visible or the tumor deemed too small for biopsy by radiologist.",[77,76,26],[104,105,106,107,77,81],"Ivonescimab","Carboplatin","Docetaxel","Neoadjuvant chemotherapy","2026-04-01",{"date":110,"type":33},"2026-04-02",{"date":112,"type":33},"2025-07-25",{"date":114,"type":19},"2032-11",{"name":116,"class":40},"Cedars-Sinai Medical Center",4,{"id":119,"slug":4,"hasResults":10,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":125,"targetDuration":4,"studyType":20,"phases":127,"briefSummary":128,"conditions":129,"keywords":134,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":4},"100630362","NCT07486687","Pembrolizumab Adjuvant in Patients With Early-stage Triple Negative Breast Cancer With Residual Disease After Neoadjuvant Pembrolizumab Plus Chemotherapy","PembroLizumab Adjuvant in Patients With Early-stage Triple NEgaTive Breast Cancer With Residual Disease After Neoadjuvant Pembrolizumab Plus Chemotherapy - the Multicenter, Randomized Phase III, Pragmatic PLANET Trial","PLANET","Inclusion Criteria:\n\n1. Male or female, ≥18 years of age on day of signing informed consent\n2. Stage II or III TNBC prior to the start of neoadjuvant treatment\n\n   1. Locally assessed stage II or III TNBC according to the primary tumor (T) and regional lymph node (N) staging as per the American Joint Committee on Cancer (AJCC) for breast cancer staging criteria version 8\n   2. Locally assessed estrogen receptor (ER) and\u002For progesterone receptor (PR) expression \\\u003C10% and HER2-negative according to the ASCO-CAP guideline1\n3. The patient has received neoadjuvant treatment with chemotherapy (containing at least anthracyclines and taxanes) and pembrolizumab, with a minimum of two 6-weekly (or four 3-weekly) cycles of pembrolizumab\n4. The patient underwent breast surgery ≤12 weeks prior to inclusion in the study\n5. The patient is scheduled to start standard of care adjuvant treatment with capecitabine or olaparib (pending reimbursement), based on non-pCR after neoadjuvant treatment, defined as RCB score \\>02\n6. World Health Organization (WHO) performance status 0-2\n7. Adequate organ function, as assessed ≤30 days prior to the screening:\n\n   1. Absolute neutrophil count (ANC) ≥1,000\u002Fmm3 (1.0 x 10e9 \u002FL)\n   2. Platelets ≥50,000\u002Fmm3 (50 x 10e9 \u002FL);\n   3. Estimated creatinine clearance ≥ 30 mL\u002Fmin as calculated using the method standard for the institution;\n   4. Total serum bilirubin ≤1.5 x upper limit of normal (ULN) (≤3.0 x ULN if Gilbert's disease);\n   5. Aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤3 x ULN\n8. Participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 6 months after the last dose of study medication\n9. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures\n10. Willingness to provide written informed consent, according to the Good Clinical Practice (GCP) and national\u002Flocal regulations\n\nExclusion Criteria:\n\n1. Contra-indications for any of the study drugs\n2. Other invasive malignancies, except when treated with curative intent without chemotherapy AND more than 5 years ago\n3. The presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule\n4. Any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study",{"count":126,"type":19},1000,[22],"The phase III, multicenter, pragmatic PLANET trial aims to evaluate the benefit and safety of pembrolizumab as an addition to standard of care adjuvant treatment (capecitabine or olaparib) in triple negative breast cancer (TNBC) patients with residual disease (non-pCR) after neoadjuvant chemotherapy and pembrolizumab. All study procedures resemble routine clinical practice as much as possible (i.e., pragmatic clinical trial). In addition to the randomized trial, a registry will be set up, in which patients who reach pCR (and therefore, do not receive adjuvant treatment) will be registered and followed.",[130,26,131,132,133],"Triple Negative Breast Cancer (TNBC), Early Setting","Triple -Negative Breast Cancer","Breast Cancer Stage II","Breast Cancer Stage III",[135,79,136,137,77,138],"Immunotherapy","Triple negative breast cancer","Breast cancer","Adjuvant","2026-03-17",{"date":141,"type":33},"2026-03-20",{"date":143,"type":19},"2026-04",{"date":145,"type":19},"2036-04",{"name":147,"class":40},"The Netherlands Cancer Institute",{"id":149,"slug":4,"hasResults":10,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":153,"eligibilityCriteria":154,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":155,"targetDuration":4,"studyType":157,"phases":4,"briefSummary":158,"conditions":159,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":91},"100542959","NCT06349642","Immune Checkpoint Inhibitor Response in Solid Tumors Using a Live Tumor Diagnostic Platform","Observational Basket Trial to Collect Tissue to Develop and Train a Live Tumor Diagnostic Platform","ELEPHAS-04","Inclusion Criteria:\n\nSubjects must meet one of the following criteria:\n\n* Subjects suspected of or diagnosed with the following Stage IV\u002Fmetastatic or recurrent malignancies:\n\n  * Lung: Non-small Cell Lung Cancer (NSCLC)\n  * Skin: Cutaneous Malignancy, excluding Uveal Melanoma\n  * Esophageal Cancer\n  * Cervical Cancer\n  * Endometrial Cancer\n  * Colon Cancer: Mismatch repair deficient (dMMR) CRC only\n  * All solid tumors with high tumor mutation burden (TMB)\n  * All solid tumors that are microsatellite instability high (MSI-H)\n  * All mismatch repair deficient (dMMR) solid tumors\n  * Liver Cancer\n  * Any solid tumor with measurable disease that is eligible for pure ICI therapy or that the clinician plans to treat with immune checkpoint inhibitor (ICI) therapy. NOTE: This can be in the setting of a trial, compassionate use, or the use of appropriate laboratory developed tests (LDTs) that, per clinician, render the patient eligible for ICI therapy, either frontline or a later line.\n\nOR\n\n* Subjects suspected of or diagnosed with the following Stage III per provider discretion or IV\u002Fmetastatic malignancies:\n\n  * Kidney: Clear Cell Renal Cell Carcinoma (ccRCC)\n  * Bladder: Urothelial Carcinoma (UC)\n  * Any solid tumor with measurable disease that is eligible for pure ICI therapy or that the clinician plans to treat with ICI therapy. NOTE: This can be in the setting of a trial, compassionate use, or the use of appropriate LDT tests that per clinician, render the patient eligible for ICI therapy, either frontline or a later line\n\nOR\n\n* Patients who will be receiving neoadjuvant CPI for the following resectable early-stage malignancies:\n\n  * Breast Cancer: Triple negative breast cancer (TNBC)\n  * Lung: Non-small cell lung cancer (NSCLC)\n\n    * NOTE: Patients with suspected NSCLC who would be eligible for neoadjuvant checkpoint inhibitor (CPI) are eligible to enroll per provider discretion\n  * Any solid tumor that is eligible for pure ICI therapy or that the clinician plans to treat with ICI therapy. NOTE: This can be in the setting of a trial, compassionate use, or the use of appropriate LDT tests that per clinician, render the patient eligible for ICI therapy, either frontline or a later line\n* LOCALLY ADVANCED\u002FMETASTATIC PATIENTS: Measurable disease as defined per protocol NOTE: Tumor lesions in a previously irradiated area are not considered measurable disease; Disease that is measurable by physical examination only is not eligible.\n* NEOADJUVANT PATIENTS: Subjects must be eligible based on investigator discretion to receive approved CPI therapy.\n* Subjects who are newly diagnosed or have suspected cancer must be treatment-naïve at the time of biopsy.\n* Subjects who are Stage I, II, or III and have progressed to metastatic cannot have received any anti-cancer treatment for at least 2 - 4 weeks (depending upon the washout period of prior anti-cancer treatment) prior to biopsy as per the agents used.\n* ECOG Performance Status (PS) 0, 1 or 2.\n* Negative pregnancy test done ≤7 days prior to enrollment, for persons of childbearing potential only\n* Female subjects must not be pregnant or breastfeeding and must use appropriate methods of contraception when applicable.\n* Subjects must be clinically able, at investigator discretion, and willing to undergo either:\n\n  * additional biopsy passes during their standard of care biopsy, OR\n  * a biopsy for research only, if applicable.\n  * NOTE: These additional biopsies may either be collected from the primary tumor or a metastatic site amenable to biopsies per the clinician.\n* Subjects with a known secondary cancer diagnosis are eligible to participate if participation does not interfere with systemic anti-cancer standard of care treatment for suspected primary diagnosis.\n* Provide written informed consent\n\nExclusion Criteria:\n\n* Pregnant women because this study involves a greater than minimal risk procedure (biopsy)\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety for the biopsy\n* Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy\n\n  * NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial\n* Uncontrolled intercurrent illness including, but not limited to:\n\n  * ongoing or active infection\n  * psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Subjects who are enrolled or plan to be enrolled in a blinded cancer therapeutic treatment trial",{"count":156,"type":19},324,"OBSERVATIONAL","This study is being done to collect tissue samples to test how accurately a tumor response platform, Elephas, can predict clinical response across multiple types of immunotherapies, chemoimmunotherapy and tumor types.",[26,160,161,162,163,164,165,166,167,168,169,170,171,172,173,174,175,176,177,178,179,180,181,182,183,184,185],"Metastatic Bladder Urothelial Carcinoma","Metastatic Cervical Carcinoma","Metastatic Clear Cell Renal Cell Carcinoma","Metastatic Colorectal Carcinoma","Metastatic Endometrial Carcinoma","Metastatic Esophageal Carcinoma","Metastatic Liver Carcinoma","Metastatic Lung Non-Small Cell Carcinoma","Metastatic Malignant Skin Neoplasm","Metastatic Malignant Solid Neoplasm","Resectable Lung Non-Small Cell Carcinoma","Early Stage Lung Non-Small Cell Carcinoma","Resectable Malignant Solid Neoplasm","Resectable Triple-Negative Breast Carcinoma","Stage III Renal Cell Cancer AJCC v8","Stage IV Cervical Cancer AJCC v8","Stage IV Renal Cell Cancer AJCC v8","Stage IV Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8","Recurrent Cervical Carcinoma","Recurrent Colorectal Carcinoma","Recurrent Endometrial Carcinoma","Recurrent Esophageal Carcinoma","Recurrent Liver Carcinoma","Recurrent Lung Non-Small Cell Carcinoma","Recurrent Malignant Skin Neoplasm","Recurrent Malignant Solid Neoplasm","2026-03-11",{"date":188,"type":33},"2026-03-12",{"date":190,"type":33},"2024-04-24",{"date":192,"type":19},"2027-05",{"name":194,"class":40},"Mayo Clinic",{"id":196,"slug":4,"hasResults":10,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":4,"eligibilityCriteria":200,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":201,"targetDuration":4,"studyType":20,"phases":203,"briefSummary":205,"conditions":206,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":117},"100541006","NCT06324240","Personalized Vaccine Immunotherapy in Combination With Checkpoint Inhibitor for Treatment of Triple Negative Breast Cancer","Clinical Evaluation of a Personalized Vaccine Immunotherapy in Combination With Checkpoint Inhibitor for Triple Negative Breast Cancer (TNBC)","Inclusion Criteria:\n\n* Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information\n* Must be age \\>= 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 14 days prior to tissue consent\n* Absolute neutrophil count \\> 1500\u002FmcL (obtained within 14 days prior to vaccine administration)\n* Absolute lymphocyte count \\>= 600 cells\u002Fµl (obtained within 14 days prior to vaccine administration)\n* Platelets \\> 100,000 mm (obtained within 14 days prior to vaccine administration)\n* Hemoglobin \\> 9.0 g\u002FdL (obtained within 14 days prior to vaccine administration) (NOTE: The use of transfusion or other intervention to achieve hemoglobin \\[Hgb\\] \\> 9.0g\u002Fdl is acceptable)\n* Serum creatinine =\\\u003C 1.5 x upper limit of normal (ULN) or calculated creatinine clearance \\>= 60 mL\u002Fmin using Cockcroft-Gault equation for patients with creatinine levels \\> 1.5 x institutional ULN (obtained within 14 days prior to vaccine administration)\n* Total bilirubin =\\\u003C 1.5 x ULN OR direct bilirubin =\\\u003C 1 x ULN (obtained within 14 days prior to vaccine administration)\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\\\u003C 2.5 x ULN unless liver metastases are present, in which case they must be =\\\u003C 5 x ULN (obtained within 14 days prior to vaccine administration)\n* Bilirubin =\\\u003C 1.5 X ULN (except in participants with documented Gilbert's disease, who must have a total bilirubin =\\\u003C 3.0 mg\u002FdL) (obtained within 14 days prior to vaccine administration)\n* International normalized ratio (INR) or prothrombin time (PT) =\\\u003C 1.5 x ULN unless patient is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants (obtained within 14 days prior to vaccine administration)\n* Activated partial thromboplastin time (aPTT) =\\\u003C 1.5 x ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants (obtained within 14 days prior to vaccine administration)\n* TNBC as defined by estrogen receptor (ER)\u002Fprogesterone receptor (PR) =\\\u003C 10% if Allred =\\\u003C 3; Her2\u002Fneu negative as defined by scores of 0 or 1+ by immunohistochemistry (IHC) or 2+ by IHC associated with a fluorescence in situ hybridization (FISH) ratio of \\\u003C 2.0 or \\\u003C 6 Her2 copies per cell\n* Patients with metastatic or inoperable locally advanced disease: Metastatic or inoperable locally advanced disease is defined as either histologically confirmed metastatic breast cancer by biopsy; or locally advanced breast cancer that, in the opinion of the treating physician, is not amenable to curative intent surgical resection; or, radiological or clinical evidence suggestive and supportive of metastatic disease\n\n  * Documented metastatic biopsy is not required provided the patient has a prior diagnosis of TNBC that otherwise meets the eligibility criteria\n  * Eligible patients must have =\\\u003C 3 lines of chemotherapy in the metastatic\u002Fadvanced disease setting. For patients who have relapsed within 6 months of systemic therapy given within curative intent, that therapy will count as a line of metastatic therapy. Last cycle of cytotoxic therapy must be \\>= 21 days prior to cycle (C)1 day (D)1 of vaccine. Last cycle of checkpoint inhibitor therapy be \\>= 28 days prior to C1D1 of vaccine. Last dose of radiotherapy must be \\>= 14 days prior to C1D1 of vaccine\n  * Prior checkpoint inhibitor is permitted. Patients who are known to have PD-L1 positive with combined positive score (CPS) \\>= 10 will be required to have had pembrolizumab therapy prior to enrollment\n  * Patients who are metastatic or inoperable, locally advanced will only be eligible for the Phase 1b combination cohort. They will not be eligible for the Phase 1a dose escalation cohort. Patients who have received prior anti-CTLA-4 antibody will preferentially be enrolled to cohort B (combination of TMV vaccine with pembrolizumab). Patients who have received prior PD-L1 or PD-1 antibody therapy will preferentially be enrolled to cohort C (combination of TMV vaccine with ipilimumab). Patients with metastatic disease who have received no prior immune checkpoint inhibitor therapy will be assigned to a treatment arm based on available slots and discretion of treating physician\n* Patients with early stage TNBC: Early stage TNBC is defined as clinical or pathologic Stage I-III TNBC\n\n  * After resection of disease in the breast and axilla, early stage patients are eligible for either the Phase 1a dose escalation of TMV vaccine monotherapy Cohort A or the Phase 1b combination arm of the vaccine with immune checkpoint inhibitor (ICI)\n  * Patients will be required to have completed adjuvant radiotherapy (if indicated) \\>= 14 days prior to initiation of vaccine on trial\n  * Patients who have residual disease after completion neoadjuvant therapy that proceed with adjuvant capecitabine can enroll \\>= 28 days after completion of final dose of capecitabine. Patients electing to enroll onto the Phase 1a Cohort A monotherapy arm can enroll prior to initiation of capecitabine, however must not initiate capecitabine prior to the Week 12 blood draw (measurement of immune biomarkers) on study\n  * Patients who have a germline BRCA 1\u002F2 mutation that meet the Food and Drug Administration (FDA) indication for use of adjuvant Olaparib can enroll \\>= 28 days after completion of final dose of olaparib. Patients electing to enroll onto the Phase 1a Cohort A monotherapy arm can enroll prior to initiation of olaparib, however must not initiate olaparib prior to the Week 12 blood draw (measurement of immune biomarkers) on study\n  * Patients who undergo upfront surgery: Patients may initiate injection of vaccine \\>= 28 days after completion of final cycle of adjuvant chemotherapy\n  * Patients who have early stage breast cancer that have residual disease after completing neoadjuvant chemotherapy with the KEYNOTE 522 regimen (pembrolizumab at a dose of 200 mg every 3 weeks plus weekly paclitaxel and carboplatin for 4 cycles followed by pembrolizumab-doxorubicin-cyclophosphamide or of pembrolizumab-epirubicin-cyclophosphamide every 3 weeks for 4 cycles):\n\n    * Patient enrolling onto Phase 1a Cohort A will initiate injection of vaccine \\>= 28 days after completion of final cycle of standard of care adjuvant pembrolizumab\n    * Patient enrolling onto Phase 1b Cohort B or C will initiate injection of vaccine \\>= 28 days surgical resection. Patients who have received pembrolizumab as part of the preoperative KEYNOTE 522 regimen will preferentially be enrolled to cohort B (combination of TMV vaccine with pembrolizumab) and will receive up to 9 cycles of adjuvant pembrolizumab every 3 weeks as per standard of care. Vaccine will be administered every 2 weeks for 3 doses prior to the first three ICI cycles\n  * Patients who have early stage breast cancer that have that have residual disease after completing neoadjuvant chemotherapy with either dose-dense doxorubicin-cyclophosphamide followed by paclitaxel or docetaxel-cyclophosphamide:\n\n    * Patient enrolling onto Phase 1a Cohort A will initiate injection of vaccine \\>= 28 days surgical resection\n    * Patient enrolling onto Phase 1b Cohort B or C will initiate injection of vaccine \\>= 28 days surgical resection. Patients will be assigned to receive either pembrolizumab (Cohort B) every 3 weeks for 6 cycles or ipilimumab (Cohort C) every 3 weeks for 4 cycles in combination with TMV vaccine based on available slots in each arm and discretion of treating physician. Vaccine will be administered every 2 weeks for 3 doses; the TMV vaccine will be administered prior to the ICI cycle if ICI is due.\n* Weight of tumor tissue for production of vaccine must be at least 1 gram. In metastatic patients, preferentially, invasive tumor in breast or lymph node tissue will be retrieved by excisional biopsy to ensure sufficient yield. In metastatic patients who undergo initiation of first-line standard of care systemic therapy off study (i.e. pembrolizumab and chemotherapy in a PD-L1 positive patient), then ideally collection of tumor tissue will occur prior to treatment initiation of standard of care therapy to maximize cellularity. Metastatic patients who have undergone mastectomy during curative treatment initially or have no invasive disease in the breast, chest wall, or accessible regional lymph nodes, will be evaluated for image-guided core biopsies of liver metastasis or video-assisted thorascopic wedge resection of lung metastasis\n\n  * In patients with early stage TNBC undergoing upfront surgery, the tumor tissue will be retrieved during lumpectomy\u002Fmastectomy. In early stage patients who are identified as high risk of having residual disease after neoadjuvant chemotherapy or undergo upfront resection, tissue will be retrieved during planned lumpectomy or mastectomy\n* Measurable disease is not required in metastatic patients but patients must have sufficient tumor to yield 1g on biopsy to enable production of personalized TMV vaccine product\n* Patients will undergo germline testing to assess for a BRCA1\u002FBRCA2 deleterious mutation. Knowledge of germline status is not required to enroll on the study\n* Able and willing to complete the entire study according to the study schedule\n* Patients must give written informed consent. A copy of the signed informed consent form will be retained in the patient's chart\n\nExclusion Criteria:\n\n* Weight of the tumor tissue is less 1 gram\n* Clinically significant comorbid conditions such as cardiovascular disease or significant peripheral vascular (e.g., uncontrolled hypertension, myocardial infarction, unstable angina) within 6 months of study entry, serious cardiac arrhythmia requiring medication, and uncontrolled infection\n* No second malignancy except prior breast cancer or except non-melanomatous skin cancer within the past 5 years\n* Ongoing or planned systemic anti-cancer therapy or radiation therapy. Last cycle of cytotoxic therapy must be \\>= 21 days prior to C1D1 of vaccine. Last cycle of checkpoint inhibitor therapy be \\>= 28 days prior to C1D1 of vaccine. Last dose of radiotherapy must be \\>= 14 days prior to C1D1 of vaccine\n* Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the pre-screening or screening visit through 120 days after the last dose of study treatment\n* Has a known history of active tuberculosis (Bacillus Tuberculosis)\n* History of allogeneic organ transplant\n* Known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least 4 weeks prior to the first dose of study treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for management of brain metastases for at least 7 days prior to study treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability\n* Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg\u002Fday of prednisone, or an equivalent corticosteroid\n* Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment\n* Known history of non-infectious pneumonitis that required steroids or any evidence of active pneumonitis\n* Failure to recover from grade 3 or 4 toxicity from previous treatment\n* For the combination cohort: prior grade 4 immune-related adverse events due to previous ICI. Patients who experienced grade 2 or 3 toxicity with prior ICI therapy may enroll if toxicity reverted to =\\\u003C grade 1",{"count":202,"type":19},18,[204],"PHASE1","This phase I trial tests the safety, side effects, and best dose of a personalized vaccine (tumor membrane vesicle or TMV vaccine) by itself and in combination with checkpoint inhibitor (pembrolizumab or ipilimumab) in treating patients with triple negative breast cancer. This vaccine is made by taking a piece of patient's triple negative breast cancer to design a vaccine to stimulate the immune system's memory. Patients are treated with the personalized vaccine immunotherapy with or without monoclonal antibodies, such as pembrolizumab and ipilimumab. This approach may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving personalized TMV vaccine with pembrolizumab or ipilimumab may help the immune system attack cancer better and reduce the risk of this breast cancer coming back or growing.",[54,207,208,25,209,210,211,27,28,212,213,26,214,215,216,217,218,219,220,221,222,223,224,225,226,227,228],"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","Anatomic Stage III Breast Cancer AJCC v8","Anatomic Stage IIIC Breast Cancer AJCC v8","Anatomic Stage IV Breast Cancer AJCC v8","Locally Advanced Triple-Negative Breast Carcinoma","Metastatic Triple-Negative Breast Carcinoma","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","Prognostic Stage IV Breast Cancer AJCC v8","Recurrent Breast Carcinoma","Unresectable Triple-Negative Breast Carcinoma","2026-01-23",{"date":231,"type":33},"2026-01-26",{"date":233,"type":33},"2025-12-02",{"date":235,"type":19},"2026-12-31",{"name":237,"class":40},"Emory University",{"id":239,"slug":4,"hasResults":10,"nctId":240,"briefTitle":241,"officialTitle":242,"acronym":4,"eligibilityCriteria":243,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":244,"targetDuration":4,"studyType":20,"phases":246,"briefSummary":247,"conditions":248,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":259},"100510694","NCT05929768","Shorter Chemo-Immunotherapy Without Anthracycline Drugs for Early-Stage Triple Negative Breast Cancer","Shorter Anthracycline-Free Chemo Immunotherapy Adapted to Pathological Response in Early Triple Negative Breast Cancer (SCARLET), A Randomized Phase III Study","Inclusion Criteria:\n\n* Participants must have histologically confirmed estrogen receptor (ER)-negative, progesterone receptor (PR)-negative, and HER2-negative breast cancer (TNBC) defined as ER \\\u003C 5%, PR \\\u003C 5%, and HER2 negative (per 2020 American Society of Clinical Oncology \\[ASCO\\] College of American Pathologists \\[CAP\\] guidelines)\n\n  * NOTE: Participants with weakly ER or PR positive disease, defined as ER and\u002For PR between 1-4% by immunohistochemistry, are eligible if adjuvant endocrine therapy is not recommended\u002Fplanned by the treating physician\n* Participants must have American Joint Committee on Cancer (AJCC) 8 anatomic tumor clinical stage either\n\n  * T2-T4, N0, M0 or\n  * T1-T3, N1-2, M0\n  * Note: All participants with clinically suspicious nodes must undergo core needle biopsy or fine needle biopsy per standard clinical practice to pathologically confirm nodal status\n* Participants must have breast and axillary imaging with mammogram and\u002For ultrasound and\u002For magnetic resonance imaging (MRI) within 49 days prior to randomization\n\n  * Note: Participants with bilateral invasive breast cancer are eligible if both breast cancers are ER-negative, PR-negative, and HER2-negative provided they meet the other eligibility criteria\n* Participants must not have T4\u002FN+, any N3, or inflammatory breast cancer\n* Participants must not have metastatic disease (M1)\n* Participants must not have received prior systemic therapy or radiation therapy with curative intent for the current breast cancer\n* Participants must not have had previous definitive ipsilateral breast surgery for the current breast cancer\n* Participants must not have current or anticipated use of other investigational agents while participating in this study\n* Participants must not have history of allergic reactions attributed to compounds of similar chemical or biologic composition as study agents\n* Participants must not have severe hypersensitivity (\\>= grade 3) to pembrolizumab or any of its excipients\n* Participants must not have received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. CTLA-4, OX-40, CD137)\n* Participants must not be currently participating in or have participated in a study of an investigational agent or used an investigational device within 28 days prior to randomization\n* Participants must be \\>= 18 years old\n* Participants must have Zubrod performance status of 0-2\n* Participants with evidence of peripheral neuropathy must have it at =\\\u003C grade 1, by Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 5.0, within 28 days prior to randomization\n* Participants must have a complete medical history and physical exam within 28 days prior to randomization\n* Hemoglobin \\>= 9.0 g\u002FdL or \\>= 5.6 mol\u002FL (within 28 days prior to randomization)\n\n  * (Criteria must be met without erythropoietin dependency and without packed red blood cell transfusion within last 2 weeks)\n* Leukocytes \\>= 3 x 10\\^3\u002FuL (within 28 days prior to randomization)\n* Absolute neutrophil count \\>= 1.5 x 10\\^3\u002FuL (within 28 days prior to randomization)\n* Platelets \\>= 100 x 10\\^3\u002FuL (within 28 days prior to randomization)\n* Total bilirubin =\\\u003C 1.5 x institutional upper limit of normal (IULN), OR direct bilirubin =\\\u003C IULN for participants with total bilirubin \\> 1.5 x IULN (unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin =\\\u003C 5 x institutional IULN) (within 28 days prior to randomization)\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\\\u003C 3 x institutional upper limit of normal (ULN) (within 28 days prior to randomization)\n* Participants must have a serum creatinine =\\\u003C the IULN OR calculated creatinine clearance \\>= 50 mL\u002Fmin\u002F1.73m\\^2 using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to registration\n* Participants must have adequate cardiac function. Participants must have left ventricular ejection fraction \\>= 50% as assessed by either echocardiography (ECHO) or multigated acquisition scan (MUGA) assessed within 28 days prior to registration. 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 and must be class 2B or better\n* Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at randomization and have undetectable viral load test on the most recent test results obtained within 6 months prior to randomization\n* Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to randomization, if indicated\n\n  * Note: No testing for Hepatitis B is required unless mandated by local health authority\n* 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 test on the most recent test results obtained within 6 months prior to randomization, if indicated\n\n  * Note: No testing for hepatitis C is required unless mandated by local health authority\n* Participants with history of diabetes must not have uncontrolled diabetes in the opinion of the treating investigator\n* Participants must not have uncontrolled hypertension in the opinion of the treating investigator\n* Participants must not have had a major surgery within 14 days prior to randomization. Participants must have fully recovered from the effects of prior major surgery in the opinion of the treating investigator\n* Participants must not have severe or active infections within 14 days prior to Randomization, including but not limited to hospitalization for infection, bacteremia, or severe pneumonia\n* Participants must not have a diagnosis of immunodeficiency and be receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to randomization\n* Participants must not have active autoimmune disease that has required systemic treatment in 2 years prior to randomization (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment\n* Participants must not have a history of (non-infectious) pneumonitis that required steroids, or has current (non-infectious) pneumonitis\n* Participants must not have received a live vaccine within 30 days prior to randomization. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist \\[registered trademark\\]) are live attenuated vaccines and are not allowed\n* Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the treatment regimen\n* Participants must not be pregnant or nursing. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. 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\n* Participants must have one (1) physical 4-5-micron single hematoxylin and eosin (H\\&E) slide from the archival pretreatment diagnostic biopsy available for submission\n* Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System\n* Participants who can complete questionnaires in English, Spanish, or French must be offered the opportunity to participate in the Patient-Reported Outcome study\n* 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* As part of the 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",{"count":245,"type":19},2400,[22],"This phase III trial compares the effects of shorter chemotherapy (chemo)-immunotherapy without anthracyclines to usual chemo-immunotherapy for the treatment of early-stage triple negative breast cancer. Paclitaxel is in a class of medications called anti-microtubule agents. It stops cancer cells from growing and dividing and may kill them. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It may also lower the body's immune response. Docetaxel is in a class of medications called taxanes. It stops cancer cells from growing and dividing and may kill them. Doxorubicin is an anthracycline chemotherapy drug that damages DNA and may kill cancer cells. Pembrolizumab may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Shorter treatment without anthracycline chemotherapy may work the same as the usual anthracycline chemotherapy treatment for early-stage triple negative breast cancer.",[54,25,27,28,26],"2025-11-04",{"date":251,"type":33},"2025-11-05",{"date":253,"type":33},"2023-09-15",{"date":255,"type":19},"2033-04",{"name":257,"class":258},"SWOG Cancer Research Network","NETWORK",963,{"id":261,"slug":4,"hasResults":10,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":4,"eligibilityCriteria":265,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":266,"enrollmentInfo":267,"targetDuration":4,"studyType":20,"phases":269,"briefSummary":271,"conditions":272,"keywords":275,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":287,"locationsCount":65},"100562971","NCT06610097","TNBC Gut Microbiota During Neoadjuvant Treatment","Impacts of Diet, Activity, and Mood on a Dynamic Gut Microbiota During Treatment for Triple-negative Breast Cancer","Inclusion Criteria:\n\n* Diagnosis of early-stage triple-negative breast cancer, not on neoadjuvant systemic therapy at the time of enrollment.\n* Age greater than or equal to 18 years and less than 100 years\n* English proficiency at or above 8th grade level\n* Expected survival greater than or equal to 12 months\n\nExclusion Criteria:\n\n* Prebiotic and\u002For probiotic use prior to and during the study","100 Years",{"count":268,"type":19},30,[270],"NA","The gut microbiome is made up of the microbes (such as bacteria, viruses, and other organisms too small to see with the naked eye) that live in the digestive tract and has been shown to be important in metabolizing food, extracting vitamins and nutrients from food, and maintaining a healthy gut lining. The gut microbiome plays an important role in overall health and has been shown to dynamically change in response to early-stage triple-negative breast cancer-directed therapies, which in turn has been associated with worse outcomes. As the gut microbiome can be further modulated with dietary changes during cancer treatment, it is an ideal potential modifiable risk factor in cancer patients. However, due to multiple confounding factors such as dietary intake, mood, and activity, its utility as part of the oncologic clinical assessment remains unclear.\n\nIn this prospective randomized controlled study, the investigators propose to recruit up to 30 early-stage TNBC patients to randomize to a personalized nutritional intervention of a high-fiber diet coached by a registered dietician versus educational handout alone during neoadjuvant treatment. The investigators propose to study the gut microbiota through stool sample analysis among early-stage triple-negative breast cancer patients undergoing neoadjuvant (i.e. before surgery) chemotherapy +\u002F- immunotherapy. The investigators will also study how the gut microbiota can be further modulated with a high-fiber diet, and the investigators hypothesize that a high-fiber diet may play a protective role in preserving gut microbial diversity. As part of the nutritional intervention, the investigators propose to administer nutritional counseling with a registered dietitian (RD) to increase fiber intake and tracking performance status, activity, and mood during neoadjuvant treatment. Finally, the investigators propose to survey participants after study completion through one-on-one interviews to determine whether participants experienced improved overall patient satisfaction in supportive care during their treatment.",[273,274,26],"Breast Cancer","Triple Negative Breast Cancer",[276,277,278,279],"gut microbiome","triple-negative breast cancer","high fiber diet","immunotherapy","2025-04-21",{"date":282,"type":33},"2025-04-23",{"date":284,"type":33},"2025-03-07",{"date":286,"type":19},"2026-06-30",{"name":288,"class":40},"Scripps Health",""]