[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastatic-her2-negative-breast-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastatic-her2-negative-breast-carcinoma":209},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,52,76,98,122,141,183],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":16,"targetDuration":4,"studyType":19,"phases":20,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100482618",false,"NCT05564377","Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial","Molecular Analysis for Combination Therapy Choice (ComboMATCH)","Inclusion Criteria:\n\n* Patient must have measurable disease\n* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status between 0-2 OR patient must have Lansky performance status of \\>= 50% or Karnofsky performance status of \\>= 50%\n* Patient must be deemed potentially eligible for a ComboMATCH Treatment Trial as assessed by the enrolling provider\n* All patients must have sequencing results available from a National Cancer Institute (NCI) credentialed Designated Laboratory (DL)\n* Patients must have locally advanced or advanced histologically documented solid tumors requiring therapy and meet one of the following criteria:\n\n  * Patients must have progressed on at least one line of standard systemic therapy OR\n  * Patients whose disease has no standard treatment that has been shown to prolong overall survival\n* Patient must meet one of the following requirements:\n\n  * Patients 18 years and older who have tumor amenable to minimal risk image-guided or direct vision biopsy and must be willing and able to undergo a tumor biopsy to obtain samples for research if the patient is to enroll in a ComboMATCH treatment trial OR\n  * Patients 18 years and older who do not have disease that is biopsiable at minimal risk to the patient must confirm availability of an archival tumor tissue specimen for submission for research if the patient enrolls to a ComboMATCH Treatment Trial. This tumor tissue must meet the following criteria:\n\n    * Tissue must have been collected within 12 months prior to registration to the EAY191 Registration Trial\n    * Patient must not have had a Response Evaluation Criteria in Solid Tumors (RECIST) response (complete response \\[CR\\] or partial response \\[PR\\]) to any intervening therapy after collection of the tissue\n    * Formalin-fixed paraffin-embedded tumor tissue block(s) or slides must be available OR\n  * Patients under 18 years old must confirm availability of an archival tumor tissue specimen for submission for research if patient enrolls to a ComboMATCH Treatment Trial. This tumor tissue must meet the following criteria:\n\n    * Formalin-fixed paraffin-embedded tumor tissue block(s) or slides must be available\n  * NOTE: See specific ComboMATCH Treatment Trial protocol for tissue collection and management instructions. Performance of the mandatory research biopsy or submission of pre-trial formalin-fixed paraffin-embedded (FFPE) and collection and submission of the blood specimens for the integrated studies will be performed under the consent authority of the specific treatment trial protocol to which the patient is registered. No procedures to collect specimens for research only are to be performed for patients registered to the EAY191 Registration Trial only\n* NOTE: Each ComboMATCH Treatment Trial contains specific eligibility criteria. If patient is found to not be eligible for the assigned ComboMATCH Treatment Trial, indication of ineligibility will trigger re-evaluation and potential assignment to another Treatment Trial","ALL",{"count":17,"type":18},2900,"ESTIMATED","INTERVENTIONAL",[21],"PHASE2","This ComboMATCH patient screening trial is the gateway to a coordinated set of clinical trials to study cancer treatment directed by genetic testing. Patients with solid tumors that have spread to nearby tissue or lymph nodes (locally advanced) or have spread to other places in the body (advanced) and have progressed on at least one line of standard systemic therapy or have no standard treatment that has been shown to prolong overall survival may be candidates for these trials. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with some genetic changes or abnormalities (mutations) may benefit from treatment that targets that particular genetic mutation. ComboMATCH is designed to match patients to a treatment that may work to control their tumor and may help doctors plan better treatment for patients with locally advanced or advanced solid tumors.",[24,25,26,27,28,29,30,31,32,33,34,35,36,37,38],"Advanced Malignant Solid Neoplasm","Anatomic Stage III Breast Cancer AJCC v8","Anatomic Stage IV Breast Cancer AJCC v8","Locally Advanced Malignant Solid Neoplasm","Malignant Female Reproductive System Neoplasm","Metastatic HER2-Negative Breast Carcinoma","Metastatic Malignant Solid Neoplasm","Recurrent Endometrial Carcinoma","Recurrent Fallopian Tube Carcinoma","Recurrent Malignant Female Reproductive System Neoplasm","Recurrent Malignant Solid Neoplasm","Recurrent Ovarian Carcinoma","Recurrent Primary Peritoneal Carcinoma","Unresectable HER2-Negative Breast Carcinoma","Unresectable Malignant Solid Neoplasm","RECRUITING","2026-07-01",{"date":42,"type":43},"2026-07-02","ACTUAL",{"date":45,"type":43},"2023-04-07",{"date":47,"type":18},"2030-07-01",{"name":49,"class":50},"National Cancer Institute (NCI)","NIH",481,{"id":53,"slug":4,"hasResults":10,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":10,"sex":15,"minAge":58,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":19,"phases":61,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":75},"100498459","NCT05770531","Circulating Tumor DNA to Guide Changes in Standard of Care Chemotherapy","A Randomized Clinical Trial Comparing ctDNA-Directed Therapy Change With Standard of Care in Patients With Metastatic Triple Negative Breast Cancer","Inclusion Criteria:\n\n* Clinical stage IV (metastatic) estrogen receptor (ER), PR, HER2 negative invasive mammary carcinoma, previously documented by histological analysis and that meets the following criteria:\n\n  * HER2 negativity is defined as any of the following by local laboratory assessment:\n\n    * In-situ hybridization (ISH) non-amplified (ratio of HER2 to CEP17 \\\u003C 2.0 or\n    * Single probe average HER2 gene copy number \\\u003C 4 signals\u002Fcell), or\n    * Immunohistochemistry (IHC) 0 or IHC 1+ (if more than one test result is available and not all results meet the inclusion criterion definition, all results should be discussed with the sponsor-investigator to establish eligibility of the patient)\n  * ER and PR negativity are defined as =\\\u003C 10% of cells expressing hormonal receptors via IHC analysis\n* PD-L1 negative (combined positive score \\[CPS\\] \\\u003C 10) or otherwise not appropriate for checkpoint inhibitors\n* Patients must have measurable disease according to the standard RECIST version 1.1\n\n  \\* NOTE: CT scans or MRIs used to assess the measurable disease must have been completed with 28 days prior to the study drug initiation\n* Patients must be age \\>= 18 years; both male and female are eligible\n* Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of =\\\u003C 2\n* Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on study\n* No prior chemotherapy regimens for metastatic disease\n* Absolute neutrophil count (ANC) \\>= 1000\u002Fmm\\^3 (obtained less than 28 days from initiation of study drug)\n* Platelet count \\>= 100,000\u002Fmm\\^3 (obtained less than 28 days from initiation of study drug)\n* Bilirubin, serum glutamic oxaloacetic transaminase (SGOT), serum glutatmic pyruvic transaminase (SGPT), alkaline phosphatase =\\\u003C 4x upper limits of normal if no liver metastases present\n* Serum total bilirubin must be \\\u003C 3x upper limits of normal for patients with Gilbert disease\n* Total bilirubin, SGOT, SGPT =\\\u003C 6x upper limits of normal if liver metastases present (obtained less than 28 days from initiation of study drug)\n* For patients who are not postmenopausal (women) or surgically sterile (absence of ovaries and\u002For uterus or vasectomy), agreement to remain abstinent or to use two adequate methods of contraception (e.g., condoms, diaphragm, vasectomy\u002Fvasectomized partner, tubal ligation), during the treatment period and for at least 30 days after the last dose of study treatment. Hormone based oral contraceptives are not allowed on study. Postmenopausal is defined as:\n\n  * Age \\>= 55 years\n  * Age =\\\u003C 55 years and amenorrheic for 12 months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression; or follicle stimulating hormone and estradiol in the postmenopausal range\n\nExclusion Criteria:\n\n* Leptomeningeal disease\n* Uncontrolled tumor-related pain: patients requiring narcotic pain medication must be on a stable regimen at registration. Symptomatic lesions (e.g., bone metastases or metastases causing nerve impingement) amenable to palliative radiotherapy should be treated prior to randomization. Patients should be recovered from the effects of radiation. There is no required minimum recovery period. Asymptomatic metastatic lesions whose further growth would likely cause functional deficits or intractable pain (e.g., epidural metastasis that is not presently associated with spinal cord compression) should be considered for loco-regional therapy if appropriate prior to randomization\n* Uncontrolled hypercalcemia (\\> 1.5 mmol\u002FL ionized calcium or calcium \\> 12 mg\u002FdL or corrected serum calcium \\> upper limit of normal \\[ULN\\]) or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy\n* Malignancies other than TNBC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer)\n* Concurrent anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, biological therapy) other than the ones specified in the protocol\n* Women only: pregnancy or lactation\n* Evidence of significant uncontrolled concomitant disease that in the opinion of the investigator could affect compliance with the protocol or interpretation of results, including significant liver disease (such as cirrhosis, uncontrolled major seizure disorder, or superior vena cava syndrome)\n* Significant cardiovascular disease, such as New York Heart Association (NYHA) cardiac disease (class II or greater), myocardial infarction within 3 months prior to randomization, unstable arrhythmias, or unstable angina. Patients with a known left ventricular ejection fraction (LVEF) \\\u003C 35% will be excluded. Patients with known coronary artery disease or congestive heart failure not meeting the above criteria must be on a stable medical regimen that is optimized in the opinion of the treating physician, in consultation with a cardiologist if appropriate\n* Major surgical procedure within 4 weeks prior to randomization or anticipation of the need for a major surgical procedure during the course of the study other than for diagnosis. Placement of central venous access catheter(s) (e.g., port or similar) is not considered a major surgical procedure and is therefore permitted\n* Psychiatric illness\u002Fsocial situations that would compromise patient safety or limit compliance with study requirements","18 Years",{"count":60,"type":18},160,[21],"This phase II trial tests how well evaluating circulating tumor deoxyribonucleic acid (ctDNA) works to guide therapy-change decisions in treating patients with triple-negative breast cancer (TNBC) that has spread from where it first started (primary site) to other places in the body (metastatic). This study wants to learn if small pieces of DNA associated with a tumor (called circulating tumor DNA, or ctDNA) can be detected in investigational blood tests during the course of standard chemotherapy treatment for breast cancer, and whether information from such investigational ctDNA blood testing could possibly be used as an early indication of chemotherapy treatment failure. It is hoped that additional information from investigational blood testing for ctDNA could help doctors to switch more quickly from a standard chemotherapy treatment that typically has significant side effects and which may not be working, to a different standard treatment regimen against TNBC, called sacituzumab govitecan. Sacituzumab govitecan is a monoclonal antibody, called hRS7, linked to a chemotherapy drug, called irinotecan. hRS7 is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as TROP2 receptors, and delivers irinotecan to kill them. Studying ctDNA may assist doctors to change therapy earlier if needed, and may improve health outcomes in patients with metastatic TNBC.",[29,64],"Metastatic Triple-Negative Breast Carcinoma","2026-06-19",{"date":67,"type":43},"2026-06-24",{"date":69,"type":43},"2023-10-03",{"date":71,"type":18},"2028-10-01",{"name":73,"class":74},"Vanderbilt-Ingram Cancer Center","OTHER",1,{"id":77,"slug":4,"hasResults":10,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":10,"sex":15,"minAge":58,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":19,"phases":84,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":75},"100556489","NCT06525766","Adaptive Therapy With Capecitabine for Treatment of Metastatic ER Positive, HER2 Negative Breast Cancer","Single Arm Pilot Trial of Adaptive Therapy (AT) With Capecitabine for the Treatment of Metastatic Estrogen Receptor Positive, Hormone Refractory Breast Cancer","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Histological confirmation of estrogen-receptor positive (ER+), HER2-negative overexpression or amplification negative as per American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guidelines, metastatic breast cancer\n* Measurable disease. Bone only disease allowed if associated with soft tissue component that is measurable by Response Evaluation Criteria is Solid Tumors (RECIST) 1.1 criteria\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2\n* Hemoglobin ≥ 9.0 g\u002FdL (obtained ≤ 14 days prior to registration), no transfusions allowed ≤ 14 days prior to registration\n* Absolute neutrophil count (ANC) ≥ 1500\u002Fmm\\^3 (obtained ≤ 14 days prior to registration)\n* Platelet count ≥ 100,000\u002Fmm\\^3 (obtained ≤ 14 days prior to registration)\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (obtained ≤ 14 days prior to registration)\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement) (obtained ≤ 14 days prior to registration)\n* Prothrombin time (PT)\u002Finternational normalized ratio (INR)\u002Factivated partial thromboplastin time (aPTT) ≤ 1.5 x ULN OR if patient is receiving anticoagulant therapy and INR or aPTT is within target range of therapy (obtained ≤ 14 days prior to registration)\n* Calculated creatinine clearance ≥ 45 ml\u002Fmin using the Cockcroft-Gault formula (obtained ≤ 14 days prior to registration)\n* Negative serum or urine pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only. NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Provide written informed consent\n* Ability to complete questionnaire(s) by themselves or with assistance\n* Willingness to provide mandatory blood specimens for correlative research\n* Ability to undergo re-staging CT scans as required by the protocol\n* Willing to return to enrolling institution at the specified frequency for follow-up (during the active monitoring phase of the study)\n\nExclusion Criteria:\n\n* Prior chemotherapy or use of antibody drug conjugate in the metastatic setting\n* Any of the following, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential who are unwilling to employ adequate contraception\n* Any of the following prior therapies:\n\n  * Major surgery ≤ 3 weeks prior to registration\n  * Radiation therapy ≤ 2 weeks prior to registration\n* Evidence of visceral crisis or impending cord compression\n* Evidence of uncontrolled brain metastasis requiring whole brain irradiation or intervention\n* Uncontrolled intercurrent illness including, but not limited to:\n\n  * ongoing or active infection\n  * symptomatic congestive heart failure\n  * unstable angina pectoris\n  * uncontrolled cardiac arrhythmia\n  * chronic oxygen dependence\n  * respiratory failure\n  * or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm\n* Other active malignancy ≤ 3 years prior to registration. EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix\n* If there is a history of prior malignancy, they must not be receiving other cancer specific treatment. Except for antiestrogen treatment (aromatase inhibitors or selective estrogen modulators) for their cancer are permitted if they meet other eligibility criteria. Denosumab and zoledronic acid, are permitted as established adjunct therapies per guidelines\n* History of myocardial infarction ≤ 6 months prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias\n* Patients known to have certain homozygous or compound heterozygous dihydropyrimidine dehydrogenase (DPYD) variants that result in complete absence of deoxypyridinoline (DPD) activity\n* History of severe hypersensitivity reactions to fluorouracil or capecitabine",{"count":83,"type":18},35,[21],"This phase II trial evaluates the effect of capecitabine on tumor response using imaging and tumor markers to adjust dose (adaptive therapy) in patients with estrogen receptor (ER) positive, HER2 negative breast cancer that has spread from where it first started to other areas in the body (metastatic). Capecitabine is in a class of medications called antimetabolites. It is taken up by tumor cells and breaks down into fluorouracil, a substance that kills tumor cells. Adaptive therapy with capecitabine based on tumor burden response may slow or stop the growth of tumor cells in patients with metastatic ER positive, HER2 negative breast cancer.",[26,87,29,88],"Estrogen-receptor-positive Breast Cancer","Metastatic Breast Cancer","2026-05-08",{"date":91,"type":43},"2026-05-11",{"date":93,"type":43},"2025-10-01",{"date":95,"type":18},"2030-10-15",{"name":97,"class":74},"Mayo Clinic",{"id":99,"slug":4,"hasResults":10,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":10,"sex":15,"minAge":58,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":19,"phases":106,"briefSummary":107,"conditions":108,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":121},"100529863","NCT06179303","Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer","A Phase II Trial to Evaluate Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer","Inclusion Criteria:\n\n* Men or women with metastatic or locally advanced unresectable breast cancer\n* Histologically confirmed ER+ \u002F HER2-negative, breast cancer who is a candidate for endocrine therapy with pathology from the primary tumor or metastatic\u002Frecurrent site. Based on American Society of Clinical Oncology\u002FCollege of American Pathologists (ASCO CAP) Guidelines: ER+: \\>= 1% of tumor cell nuclei to be immunoreactive. HER2-negative: HER2 of 0, 1+ by immunohistochemistry (IHC) or negative by fluorescence in situ hybridization (FISH).\n\n  * In the case of bone biopsy which could yield false negative ER or PR status in patients with historically HR+ disease, a patient may be eligible if the treating physician and the study chair both agree that the patient is a candidate for further endocrine therapy (ET) based treatment.\n  * Note that baseline PR status by IHC does not influence results of deltaFFNP-PET imaging.\n* If premenopausal, the patient has to be treated with GnRH agonist for at least 6 weeks prior to FFNP-PET.\n* Disease must be present in at least one non-liver site and measurable by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria and be 1.5 cm or greater in longest dimension OR disease can be non-measurable but must be 1.5 cm in longest dimension on functional imaging (fluorodeoxyglucose \\[FDG\\]-PET\u002Fcomputed tomography \\[CT\\] preferred).\n* No limits to prior lines of endocrine therapy in the metastatic setting including synergistic targeted therapy such as CDK4\u002F6 inhibitors (other than Abemaciclib), PI3K inhibitor, mTOR inhibitor, etc. One line of prior cytotoxic chemotherapy in the metastatic setting is allowed. Washout from prior systemic anti-cancer therapy of at least 2 weeks from chemotherapy or radiation, 2 weeks or 5 half lives (whichever is longer) from oral selective estrogen receptor degrader (SERD), 8 weeks from oral selective estrogen receptor modulator (SERM), and 16 weeks from intramuscular SERD (Fulvestrant) is required. Recovery of adverse events from the last therapy to grade 1 except alopecia. Patients may continue luteinizing hormone-releasing hormone (LHRH) agonist to remain post-menopausal without a need for washout\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2\n* At least 18 years of age\n* Absolute neutrophil count \\>= 1,500\u002FuL\n* Platelets \\>= 100,000\u002FuL\n* Hemoglobin \\>= 9g\u002FdL\n* Total bilirubin =\\\u003C 1.5 x institutional upper limit of normal (ULN).\n\n  * In case of known Gilbert's syndrome, \\\u003C 2 x ULN is allowed\n* Aspartate aminotransferase (AST) serum glutamic oxaloacetic transaminase (SGOT) \u002Falanine aminotransferase (ALT) serum glutamic pyruvic transaminase (SGPT) =\\\u003C 2.5x institutional ULN, or =\\\u003C 5 x ULN for subjects with documented metastatic disease to the liver\n* eGFR (estimated glomerular filtration rate) ≥ 30 mL\u002Fmin\n* Women of childbearing potential must agree to use adequate contraception (barrier method of birth control, abstinence) prior to study entry and for the duration of study participation\n* Ability to understand and willingness to sign an institutional review board (IRB)-approved written informed consent document (or that of legally authorizes representative, if applicable)\n* Consent to access archival tumor specimens for clinical sequencing data of tumor tissue and blood\n\nExclusion Criteria:\n\n* Prior abemaciclib in the metastatic setting or within 2 years of completion of adjuvant abemaciclib\n* Hepatic-only metastatic disease\n* A history of other malignancy with the exception of malignancies for which all treatment was completed at least 2 years before registration and the patient has no evidence of disease\n* Currently receiving any other investigational agents\n* Untreated\u002Funstable brain metastases. Patients with treated\u002Fstable brain metastases, defines as patients who have received prior therapy for their brain metastases and whose central nervous system (CNS) disease is radiographically stable at study entry, are eligible\n* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to FFNP, abemaciclib, or other agents used in the study\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia\n* Pregnant and\u002For breastfeeding women of childbearing potential must have a negative pregnancy test within 14 days of study entry. Male participants and female participants of childbearing potential must utilize adequate contraceptive methods throughout study treatment and for at least 30 days after the last dose of study medications\n* Patients with human immunodeficiency virus (HIV) are eligible unless their CD4+ T-cell counts are \\\u003C 350 cells\u002FmcL or they have a history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective antiretroviral therapy (ART) according to Department of Health and Human Services (DHHS) treatment guidelines is recommended",{"count":105,"type":18},60,[21],"This phase II trial tests the accuracy of functional imaging (FFNP)-positron emission tomography (PET)\u002Fcomputed tomography (CT) to predict response to abemaciclib plus endocrine therapy. Abemaciclib is a drug used to treat certain types of hormone receptor positive (HR+), HER2 negative breast cancer. Abemaciclib blocks certain proteins, which may help keep tumor cells from growing. Endocrine therapy adds, blocks, or removes hormones that can cause cancer to grow. FFNP PET imaging is a form of x-ray that uses FFNP as an imaging agent that may provide more precise information about the location of tumors that \"light up\" with FFNP than a PET scan alone can provide.",[25,26,109,110,29,111],"Locally Advanced Unresectable HER2-Negative Breast Carcinoma","Locally Advanced Unresectable Hormone Receptor-Positive Breast Carcinoma","Metastatic Hormone Receptor-Positive Breast Carcinoma","2026-04-14",{"date":114,"type":43},"2026-04-16",{"date":116,"type":43},"2024-07-22",{"date":118,"type":18},"2028-06-01",{"name":120,"class":74},"University of Washington",2,{"id":123,"slug":4,"hasResults":10,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":4,"eligibilityCriteria":127,"healthyVolunteers":10,"sex":15,"minAge":58,"maxAge":4,"enrollmentInfo":128,"targetDuration":4,"studyType":19,"phases":130,"briefSummary":131,"conditions":132,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":75},"100601558","NCT07112053","A Vaccine (STEMVAC) With Standard Endocrine-Based Therapy or Chemotherapy for the Treatment of Metastatic Hormone Receptor Positive, HER2 Negative Breast Cancer","A Phase II Study of STEMVAC Vaccine Therapy for Patients With Hormone Receptor Positive Metastatic Breast Cancer","Inclusion Criteria:\n\n* Patients must be at least ≥ 18 years of age\n* Histologically confirmed hormone receptor positive metastatic breast cancer: Tumors that are positive for estrogen receptor (ER) and\u002For progesterone receptor (PR)\n* HER2-negative or HER2-low will be included and defined as:\n\n  * 0-1+ HER2 expression by immunohistochemistry (IHC) OR\n  * Fluorescence in situ hybridization (FISH) negative OR\n  * HER2 2+ and FISH negative\n  * HER2 low per standard of care in breast cancer\n* Patients should be receiving the following therapies to be eligible for the study:\n\n  * Cohort 1: First or second line of endocrine therapy in the metastatic setting, in combination with a CDK4\u002F6 inhibitor. Patients must have completed at least 2 cycles of CDK4\u002F6 inhibitor. Patients who have stopped endocrine therapy for intolerance but remain on abemaciclib monotherapy will be considered for enrollment at the PI's discretion\n  * Cohort 2: Progressed on endocrine-based therapies and after completion of at least 1 cycle of capecitabine\n* Subjects with Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0 or 1\n* Willing to undergo up to two serial biopsies while on study\n* Have at least 1 site of disease confirmed by the treating oncologist that could be biopsied during treatment\n* White blood cell (WBC) ≥ 2000\u002Fmm\\^3 (within 28 days of receiving the study vaccine)\n* Lymphocyte count ≥ 500\u002Fmm\\^3 (within 28 days of receiving the study vaccine)\n* Absolute neutrophil count (ANC) ≥ 800\u002FµL (within 28 days of receiving the study vaccine)\n* Platelets ≥ 75,000\u002FµL (within 28 days of receiving the study vaccine)\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN), except patients with Gilbert's syndrome in whom total bilirubin must be ≤ 3.0 mg\u002FdL (within 28 days of receiving the study vaccine)\n* Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) ≤ 3 x institutional upper limit of normal (ULN) (within 28 days of receiving the study vaccine)\n* Creatinine ≤ 2.0 mg\u002FdL or creatinine clearance \\> 30 mL\u002Fmin (within 28 days of receiving the study vaccine)\n* 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 postmenopausal. Effective methods of contraception must be used throughout the study and until the end of treatment on study\n* Must have recovered from major infections and\u002For surgical procedures; and in the opinion of the investigator, not have any significant active concurrent medical illnesses or condition precluding protocol treatment\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 hypertension\n  * Uncontrolled cardiac arrhythmias\n* Patients with any autoimmune disease\u002Fcomorbidity that require chronic steroids or immunosuppressants\n* A non-breast malignancy requiring radiation or systemic therapy within last 5 years\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 history of human immunodeficiency virus (HIV) infection, hepatitis B (e.g., hepatitis B virus surface antigen \\[HBsAg\\] reactive), or hepatitis C (e.g., hepatitis C virus \\[HCV\\] ribonucleic acid \\[RNA\\] \\[qualitative\\] is detected)\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, and inhalational corticosteroids (with minimal systemic absorption) are allowed. Patients who have received systemic corticosteroids ≤ 30 days prior to starting study drug will be excluded\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\n  * NOTE: Biomarker or tissue collection or any other non-interventional clinical trial enrollment is allowed\n* Must be 14 days between a non-study vaccine and any STEMVAC vaccination\n\n  * NOTE: The minimum of 14 days does not apply to the tetanus and diphtheria (Td) vaccine\n* Any condition that may interfere with the patient's participation in the study per treating oncologist",{"count":129,"type":18},40,[21],"This phase II trial studies how well a vaccine, STEMVAC, works in combination with standard endocrine-based therapy (ET) with a CDK4\u002F6 targeted drug therapy, or with the chemotherapy drug capecitabine, in treating patients with hormone receptor (HR)-positive, HER2-negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic). STEMVAC is designed to target proteins that cancer cells use when they become more aggressive and start to spread, and it is believed to work by boosting the immune system to recognize and destroy the invader tumor cells that are causing the disease. Standard ET is treatment that adds, blocks, or removes hormones in order to slow or stop the growth of cancer. Standard CDK4\u002F6 inhibitors, including abemaciclib, may stop the growth of tumor cells and may kill them by blocking some of the enzymes needed for cell growth. Capecitabine is in a class of medications called antimetabolites. It is taken up by tumor cells and breaks down into fluorouracil, a substance that kills tumor cells. Giving STEMVAC in combination with standard ET or chemotherapy may be an effective treatment for metastatic HR positive, HER2 negative breast cancer.",[26,29,111],"2026-04-01",{"date":135,"type":43},"2026-04-06",{"date":137,"type":43},"2025-11-17",{"date":139,"type":18},"2028-12-31",{"name":120,"class":74},{"id":142,"slug":4,"hasResults":10,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":4,"eligibilityCriteria":146,"healthyVolunteers":10,"sex":15,"minAge":58,"maxAge":4,"enrollmentInfo":147,"targetDuration":4,"studyType":19,"phases":149,"briefSummary":151,"conditions":152,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":75},"100446805","NCT05098210","Personalized Neo-Antigen Peptide Vaccine for the Treatment of Stage IIIC-IV Melanoma, Hormone Receptor Positive HER2 Negative Metastatic Refractory Breast Cancer or Stage III-IV Non-Small Cell Lung Cancer","PNV21-001: A Phase I Study of a Personalized Multi-Peptide Neo-Antigen Vaccine in Breast Cancer, PD1\u002FPD-L1 Inhibitor-Refractory Melanoma, and Pretreated Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* Female and\u002For male patients age \\>= 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2\n* Patients must have at least 1 lesion (or aggregate lesions) to obtain tumor tissue for resection of \\>= 1 cm or \\>= 4 core biopsies acceptable. Amenable to image (CT, ultrasound \\[U\u002FS\\], or magnetic resonance imaging \\[MRI\\]) guided biopsy for tissue collection necessary for neoantigen identification. Either primary or metastatic sites are options for tissue collection\n* Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria: Participants must have measurable disease, defined as at least one target lesion that can be measured in at least one dimension (longest diameter to be recorded) as \\>= 10 mm, unless lymph node in which case short axis must be \\>= 15 mm. Baseline imaging (for example diagnostic CT chest\u002Fabdomen\u002Fpelvis, PET CT scan and imaging of the affected extremity as appropriate), brain imaging (MRI or CT scan) must be obtained within 45 days of prior to start of first planned vaccine dose infusion. MRI can be substituted for CT in patients unable to have CT contrast\n* Serum creatine \\\u003C 1.5 mg\u002FdL or estimated glomerular filtration rate (eGFR) \\> 60 mL\u002Fmin\n* Total bilirubin (tBili) \\\u003C 1.5 x upper limit of normal (ULN) and an aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) \\\u003C 2.5 x ULN and \\\u003C 5 x ULN for subjects with documented liver metastasis. Patients with suspected Gilbert syndrome may be included if tBili \\> 3 but no other evidence of hepatic dysfunction\n* =\\\u003C grade 1 dyspnea and arterial oxygen saturation (SaO2) \\>= 92% on ambient air. If pulmonary function tests (PFTs) are performed based on the clinical judgement of the treating physician, patients with forced expiratory volume in 1 second (FEVI) \\>= 70% of predicted and carbon monoxide diffusing capability (DLCO) (corrected) of \\>= 60% of predicted will be eligible\n* Patients with active interstitial lung disease (ILD)\u002Fpneumonitis or a history of ILD\u002Fpneumonitis requiring treatment with systemic steroids will be excluded\n* Patients 60 years of age or older are required to have left ventricular ejection fraction (LVEF) evaluation performed within 60 days prior to enrollment. LVEF may be established with echocardiogram or MUGA scan, and left ejection fraction must be \\>= 50%. Cardiac evaluation for other patients is at the discretion of the treating physician\n* Subjects with a history of myocarditis or congestive heart failure (as defined by New York Heart Association functional classification III or IV), as well as unstable angina, serious uncontrolled cardiac arrhythmia, uncontrolled infection, or myocardial infarction 6 months prior to study entry will be excluded\n* Absolute neutrophil count (ANC) \\> 1000 cells\u002Fmm\\^3\n* Hemoglobin \\>= 9 mg\u002FdL\n* Platelet count \\>= 50,000\u002FuL\n* Toxicity from prior therapy must be recovered to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v.)5 grade 2 or less\n* Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other procedures\n* Capable of understanding and providing a written informed consent\n* The effects of neoantigen vaccination on the developing human fetus are unknown. For this reason, patients who are having sex that can lead to pregnancy must agree to use adequate contraception (hormonal, barrier method of birth control, or abstinence) for the duration of study participation. Should a woman become pregnant while participating in the study, she should inform her study doctor immediately and will not receive any more study treatment\n* MELANOMA SPECIFIC: Tissue confirmation of melanoma: Histologically confirmed metastatic (recurrent or de novo stage IV) or unresectable locally advanced (stage IIIC or IIID) cutaneous, acral, conjunctival or mucosal melanoma, as defined by the American Joint Committee on Cancer (AJCC) v8.0. Confirmation of diagnosis must be or have been performed by internal pathology review of archival, initial or subsequent biopsy or other pathologic material at Fred Hutchinson Cancer Center (FHCC)\u002FUniversity of Washington Medical Center (UWMC)\n* MELANOMA SPECIFIC: Patients must have received stage specific standard of care therapy per National Comprehensive Cancer Network (NCCN) guidelines and have persistent\u002Frecurrent disease after at least one line of therapy prior to enrollment on the study\n* MELANOMA SPECIFIC: Known BRAF mutational status\n* MELANOMA SPECIFIC: History of detectable disease during\u002Fafter treatment with a PD-1 or PD-L1 inhibitor, as defined by the Society of Immunotherapy of Cancer's definition of primary or secondary resistance (Kluger and others \\[et al.\\], 2020):\n\n  * Drug exposure \\>= 6 weeks and best response progressive disease (PD) or stable disease (SD) \\\u003C 6 months or\n  * Drug exposure \\>= 6 months and best response complete response (CR), partial response (PR), or SD \\> 6 months\n* MELANOMA SPECIFIC: A confirmatory scan performed at least 4 weeks after disease persistence\u002Fprogression is required but this requirement can be waived if the judgement of the treating clinician is that the patient would be at risk of rapid or symptomatic progression in that interval. This confirmatory scan can occur during production of the vaccine after enrollment\n* BREAST CANCER SPECIFIC: Tissue confirmation of stage IV (recurrent or de novo metastatic) hormone receptor (HR) positive, HER2 negative breast cancer:\n\n  * Hormone receptor (HR) positive breast cancer as defined by either one, or both of the following criteria:\n\n    * Estrogen receptor (ER) positive disease defined as follows documented by a local laboratory: 1-100% positive stained cells based on de novo tumor biopsy\n    * Progesterone receptor (PR) positive disease defined as follows documented by a local laboratory: 1-100% positive stained cells based on de novo tumor biopsy\n  * Human epidermal growth factor receptor 2 (HER2) negative breast cancer (per American Society of Clinical Oncology \\[ASCO\\]\u002FCollege of American Pathologists \\[CAP\\] guideline update, 2018) as documented by a local laboratory with HER2-negativity defined as:\n\n    * Immunohistochemistry score 0\u002F1+ or 2+ and \u002F or\n    * Negative by in situ hybridization (fluorescence in situ hybridization \\[FISH\\]\u002Fchromogenic in situ hybridization \\[CISH\\]\u002Fsilver-enhanced in situ hybridization \\[SISH\\]) per ASCO\u002FCAP guideline update, 2018\n  * Confirmation of diagnosis must be or have been performed by internal pathology review of archival, initial or subsequent biopsy or other pathologic material at FHCC\u002FUWMC\n* BREAST CANCER SPECIFIC: Patients must have received at least one line of systemic therapy in the metastatic setting prior to enrollment on the study and have progressive\u002Fpersistent disease after\n* NON-SMALL CELL LUNG CANCER SPECIFIC: Tissue confirmation of stage III unresectable or stage IV (recurrent or de novo metastatic) non-small cell lung cancer (NSCLC):\n\n  * Genetic testing must have been performed for targetable driver mutations, including EGFR, ROS1, Alk, KRAS, BRAF\n  * Confirmation of diagnosis must be or have been performed by internal pathology review of archival, initial or subsequent biopsy or other pathologic material at FHCC\u002FUWMC\n* NON-SMALL CELL LUNG CANCER SPECIFIC: Patients must have received at least one line of systemic therapy in the metastatic or stage II or III setting including a PD-1 or PD-L1 inhibitor prior to enrollment on the study and have progressive or recurrent disease after\n* NON-SMALL CELL LUNG CANCER SPECIFIC: For patients who have received neoadjuvant, adjuvant, and\u002For consolidation anti-PD-1 or anti-PD-L1 for stage II or III disease, they must have experienced disease progression in less than or equal to 365 days from initiation (cycle 1 day 1) of anti-PD-1 or anti-PD-L1 therapy for this to count as the systemic therapy for advanced disease. Patients experiencing progression more than 365 days from initiation (cycle 1 day 1) of anti-PD-1 or anti-PD-L1 therapy will not be considered as having received one line of systemic therapy. These patients must have received an anti-PD-1 or anti-PD-L1 therapy for stage IV or recurrent disease\n\nExclusion Criteria:\n\n* Fertile male patients and female patients of childbearing potential who are unwilling or unable to use 2 highly effective methods of contraception as outlined in this protocol for the duration of the study and for at least 5 months after the last dose of investigational product\n* Any history of an immune-related grade 4 adverse event attributed to prior cancer immunotherapy CIT (other than endocrinopathy managed with replacement therapy or asymptomatic elevation of serum amylase or lipase)\n* Any history of an immune-related grade 3 adverse event attributed to prior CIT that required permanent discontinuation of PD-1 inhibitor therapy\n* Immune-related adverse events related to prior CIT (other than endocrinopathy managed with replacement therapy or stable vitiligo) that have not resolved to baseline. Patients treated with corticosteroids for immune-related adverse events must demonstrate absence of related symptoms or signs for \\>= 4 weeks following discontinuation of corticosteroids\n* Uncontrolled tumor-related pain. Patients requiring narcotic pain medication must be on a stable regimen at study entry. Symptomatic lesions amenable to palliative radiotherapy (e.g., bone metastases or metastases causing nerve impingement) should be treated \\> 4 weeks prior to enrollment. Patients should be recovered from the effects of radiation\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage more than once every 28 days. Indwelling drainage catheters (e.g., PleurX®) are allowed\n* Patients with known symptomatic brain metastases. Patients with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to study entry, have discontinued corticosteroid treatment for these metastases for at least 4 weeks and are neurologically stable for \\>= 1 months (confirmed by magnetic resonance imaging \\[MRI\\])\n* Patients with rapidly progressing disease, symptomatic visceral disease, or patients who are expected to have rapidly progressive disease over the course of several months despite bridging therapy approved by the protocol\n* Known primary immunodeficiencies, either cellular (e.g., DiGeorge syndrome, T-negative severe combined immunodeficiency \\[SCID\\]) or combined T- and B-cell immunodeficiencies (e.g., T- and B-negative SCID, Wiskott-Aldrich syndrome, ataxia telangiectasia, common variable immunodeficiency)\n* Prior allogeneic bone marrow transplantation or prior solid organ transplantation\n* Known positive test for HIV infection\n* Patients with active infection causing fever (temperature \\> 38.1 degrees Celsius \\[C\\]) or subjects with unexplained fever (temperature \\> 38.1 degrees C) may not receive the investigational product unless the fever is =\\\u003C 38.1 for 5 days prior to start\n* Active uncontrolled infection: individuals with a history of hepatitis C who have successfully completed antiviral therapy with an undetectable viral load, and those with hepatitis B who have, per standard practice, hepatitis well-controlled on medication (e.g., AST and ALT \\\u003C 5 x ULN) can be included\n* History of autoimmune disease that has not been controlled with treatment in the last 12 months, including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener granulomatosis, Sjogren syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis, or glomerulonephritis with the following exceptions: Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible. Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible. Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., no psoriatic arthritis) may be eligible\n* Treatment with systemic immunosuppressive medications (including, but not limited to, prednisone \\> 10 mg\u002Fday or equivalent, cyclophosphamide, azathioprine, methotrexate, thalidomide, and TNF-alpha antagonists) within 2 weeks prior screening. The use of topical, eye drops, local injections, or inhaled corticosteroids (e.g. fluticasone for chronic obstructive pulmonary disease) is allowed. The use of oral mineralocorticoids (e.g. fludrocortisone for patients with orthostatic hypotension) is allowed. Physiologic doses of corticosteroids for adrenal insufficiency are allowed. Low dose corticosteroids for a short duration \\[5 mg once daily (QD) prednisone for 2 weeks\\] as symptomatic treatment and upon with discussion with the investigator is allowed. Note: Patients with adrenal insufficiency may take 10 mg of prednisone or equivalent daily\n* Subjects should have an international normalized ratio (INR) or activated partial thromboplastin time (aPTT) =\\\u003C 1.5 X ULN unless the subject is receiving anticoagulant therapy. Subjects on anticoagulant therapy should have a prothrombin time (PT) or partial thromboplastin time (PTT) within therapeutic range of intended use and no history of severe hemorrhage. Antiplatelet agents (eg, aspirin, clopidogrel, etc.) are not considered anticoagulants for the purposes of this study (i.e., they are allowed)\n* Other medical, social, or psychiatric factor that interferes with medical appropriateness and\u002For ability to comply with study, as determined by the principal investigator (PI)\n* Participants of childbearing potential must have a negative serum pregnancy test within 14 days prior to enrollment. Childbearing potential is defined as women who have not been surgically sterilized and who are not post-menopausal (free of menses for at least 1 year)\n* Female patients who are lactating or intend to breastfeed during the duration of the study\n* Patients who have received a live vaccine within 30 days prior to enrollment\n* Patients with any underlying medical condition for which, in the investigator's opinion, participation would not be in the best interest of the participant (e.g.- compromises the health of the subject) or that could prevent, limit or confound protocol assessments\n* MELANOMA SPECIFIC: Uveal or choroidal melanoma. This entity is excluded due to the absence of abundant mutations\n* BREAST SPECIFIC: Patients with symptomatic disease including patients with symptomatic lung metastases, bone marrow replacement with associated cytopenia, or significant liver metastases with associated liver dysfunction\n* NON-SMALL CELL LUNG CANCER SPECIFIC: Activating mutations in EGFR or genetic alterations in ROS1 or Alk, as these mutations are associated with lower mutation burden and non-response to immune therapies",{"count":148,"type":18},25,[150],"PHASE1","This phase I trial studies the safety of personalized neo-antigen peptide vaccine in treating patients with stage IIIC-IV melanoma, hormone receptor positive HER2 negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or does not respond to treatment (refractory) or stage III-IV non-small cell lung cancer. Personalized neo-antigen peptide vaccine is a product that combines multiple patient specific neo-antigens. Given personalized neo-antigen peptide vaccine together with Th1 polarizing adjuvant poly ICLC may induce a polyclonal, poly-epitope, cytolytic T cell immunity against the patient's tumor.",[26,153,154,155,156,157,158,29,111,159,30,160,161,162,163,164,165,166,167,168,169,170,171,172,173],"Clinical Stage IV Cutaneous Melanoma AJCC v8","Locally Advanced Cutaneous Melanoma","Locally Advanced Mucosal Melanoma","Metastatic Acral Melanoma","Metastatic Conjunctival Melanoma","Metastatic Cutaneous Melanoma","Metastatic Lung Non-Small Cell Carcinoma","Metastatic Mucosal Melanoma","Pathologic Stage IIIC Cutaneous Melanoma AJCC v8","Pathologic Stage IIID Cutaneous Melanoma AJCC v8","Recurrent Cutaneous Melanoma","Recurrent HER2-Negative Breast Carcinoma","Recurrent Hormone Receptor-Positive Breast Carcinoma","Recurrent Lung Non-Small Cell Carcinoma","Recurrent Mucosal Melanoma","Stage III Lung Cancer AJCC v8","Stage IV Lung Cancer AJCC v8","Unresectable Acral Melanoma","Unresectable Cutaneous Melanoma","Unresectable Lung Non-Small Cell Carcinoma","Unresectable Mucosal Melanoma","2026-03-10",{"date":176,"type":43},"2026-03-12",{"date":178,"type":43},"2022-06-09",{"date":180,"type":18},"2028-11-01",{"name":182,"class":74},"Fred Hutchinson Cancer Center",{"id":184,"slug":4,"hasResults":10,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":4,"eligibilityCriteria":188,"healthyVolunteers":10,"sex":189,"minAge":58,"maxAge":190,"enrollmentInfo":191,"targetDuration":4,"studyType":19,"phases":193,"briefSummary":194,"conditions":195,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":75},"100480394","NCT05535413","UTD1 Combined With Capecitabine in Metastatic HER2-negative Breast Cancer Patients With Brain Metastases","A Single-arm, Multicenter, Open-labeled Clinical Study of UTD1 Combined With Capecitabine in Metastatic HER2-negative Breast Cancer Patients With Brain Metastases","Inclusion Criteria:\n\n* Patients aged 18 to 70 years\n* With histologically confirmed HER2 negative recurrent and metastatic breast cancer\n* have at least one measurable lesion in the central nervous system (the longest diameter ≥ 10mm)\n* ECOG score (PS) of 0-2\n* According to screening brain MRI, patients with CNS must meet the following conditions:\n\n  1. untreated brain metastases of breast cancer;\n  2. do not need immediate local treatment;\n  3. brain metastases of breast cancer which was treated in the past:\n\n     1. There are no clinical manifestations that have progressed after the previous local treatment of the central nervous system and require immediate local treatment.\n     2. All records related to the treatment of the central nervous system must be provided.\n     3. All toxicities related to the previous anti-tumor treatment of patients who have not received chemotherapy, radiotherapy, surgical treatment, targeted therapy and immunotherapy within 4 weeks before enrollment must be restored to ≤ level 1 (CTCAE v50). However, patients with hair loss of any grade are allowed to be recruited.\n* Blood routine examination was basically normal within 1 week before enrollment.\n* White blood cell count (WBC) ≥ 30 × 109 \u002FL\n* Neutrophil counts (ANC) ≥ 15 × 109\u002FL\n* Platelet count (PLT) ≥ 100 × 109 \u002FL\n* Hemoglobin ≥ 90g\u002Fdl. Patients can receive blood transfusion or erythropoietin treatment to meet this standard.\n* Within 1 week before enrollment, the liver and kidney function tests were basically normal (based on the normal value of the laboratory of each research center).\n* Total bilirubin ≤ 15 × Upper limit of normal value (ULN)\n* Alanine aminotransferase (SGPT \u002F ALT) ≤ 25 x ULN (patients with liver metastasis ≤ 5 × ULN)\n* Glutamic oxaloacetic transaminase (SGOT\u002FAST) ≤ 25 × ULN (patients with liver metastasis ≤ 5 × ULN)\n* Creatinine clearance rate (Ccr) ≥ 60ml\u002Fmin patients\n* With fertility must agree to use effective contraceptive methods during the study period and within 90 days of the last study medication. Before enrollment, the blood or urine pregnancy test must be negative and the\n* Life expectancy \\> 12 weeks.\n* The patient must be able to participate in and follow the treatment and follow-up.\n\nExclusion Criteria:\n\n* Primary or metastatic lesions were HER2 positive (HER2 IHC or FISH positive)\n* Other malignant carcinomas (including primary brain or leptomeningeal related tumors) in the past 5 years, except for the cured basal cell carcinoma of the skin and carcinoma in situ of the cervix.\n* Anti tumor treatment, including chemotherapeutic radical radiotherapy, hormone therapy, biological therapy Immunotherapy or anti-tumor traditional Chinese medicine.\n* Patients who have received surgical operation on major organs (excluding puncture biopsy) or have suffered significant trauma within 4 weeks before the first use of the study drug, or who need to undergo elective surgery during the trial.\n* Patients with symptomatic peripheral neuropathy with grade evaluation ≥ 2 (CTCAE 5.0), who have previously used anti-microtubule drugs and have serious adverse reactions related to the nervous system of grade 3 or above.\n* Use capecitabine within 6 months before enrollment; No response to capecitabine in the past (including progression during capecitabine treatment, or duration of clinical response after treatment \\\u003C 3 months) or unable to tolerate to capecitabine.\n* For any brain lesions requiring immediate local treatment, such as increased lesion size or treatment-related edema at intracranial (but not limited to) anatomical sites may pose risks to patients (e.g., brainstem lesions)\n* Known or suspected leptomeningeal disease (LMD)\n* Other non malignant systemic diseases (cardiovascular, renal, liver, etc.) that are excluded from any treatment regimen or interfere with follow-up in pregnant or lactating women.\n* Known or suspected allergy to any study drug or accessories.\n* Brain MRI can not be performed for any other reason.\n* The investigator considers it inappropriate to participate in.\n* Other situations where corticosteroids are prohibited.","FEMALE","70 Years",{"count":192,"type":18},30,[150,21],"This study is a single-arm, multicenter, open-labeled clinical study of UTD1 combined with Capecitabine in metastatic HER2-negative breast cancaner patients with brain metastases. This study aims to evaluate the efficacy and safety of UDT1 combined with capecitabine in metastatic HER2-negative breast cancer patients with brain metastases.",[196,197,198,199],"Metastatic HER2 Negative Breast Carcinoma","Brain Metastases","Capecitabine","UDT1","2025-04-23",{"date":202,"type":43},"2025-04-25",{"date":204,"type":43},"2023-01-01",{"date":206,"type":18},"2025-07",{"name":208,"class":74},"Hunan Cancer Hospital",""]