[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"triple-negative-breast-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:triple-negative-breast-carcinoma":108},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,142,168,203,225,249,276,309,337,356,377],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":141},"100459958","phase-1-personalized-neoantigen-peptide-based-vaccine-in-combination-with-pembrolizumab-for-treatment-of-advanced-solid-tumors-100459958",false,"NCT05269381","Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab for Treatment of Advanced Solid Tumors","A Phase I\u002FII Study of Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab in Advanced Solid Tumors (PNeoVCA)","PNeoVCA","Inclusion Criteria COHORT 1 and COHORT 2 are no longer enrolling.\n\nPHASE I PRE-REGISTRATION, ALL:\n\n* Willing to provide tissue specimens per protocol, or have clinically collected formalin-fixed paraffin-embedded (FFPE) tissue blocks, or available sequencing data available from commercial or research tests\n\n  * NOTE 1: Includes fresh tissue specimen at pre-registration, or with or clinically collected FFPE tissue blocks for complete exome and transcriptome sequencing. Patients who had tumor sequencing under certain Mayo IRB protocols and neoantigen has been identified or REAL Neo vaccine produced are allowed to proceed to pre-registration and\u002For registration.\n  * NOTE 2: This criteria will not apply to patients who had sequencing and neoantigen prediction previously completed.\n* Measurable disease as defined by RECIST (v 1.1) criteria or non-measurable disease\n\n  * NOTE: Tumor lesions in previously irradiated area are not considered measurable disease\n* Patients with actionable genomic abnormality including, but not limited to EGFR, ALK, MET, ROS-1, RET, NTRK, KRAS or BRAF must have received and progressed on at least one line of prior FDA-approved targeted therapy\n* Provide written informed consent. For pediatric patients (age 16-17 years):\n\n  * Written informed consent from legal guardian(s) and\u002For child obtained in accordance with local regulations.\n* Willing to return to enrolling institution for follow-up\n* Willing to provide blood specimens for research\n* Negative pregnancy test 7 days prior to pre-registration for persons of childbearing potential.\n* Willing to employ highly effective method of contraception from pre-registration through 6 months after final vaccine cycle\n* Willing to receive tetanus vaccination if subject has not had one ≤ 1 year prior to pre-registration\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1\n* Anticipated life expectancy \\> 6 months\n* Recovered from all toxicities associated with prior treatment to acceptable baseline status (see specified inclusion limits for laboratory toxicity) or National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5 Grade 0 or 1, except for toxicities not considered safety risk per treating investigator (e.g., alopecia or vitiligo).\n* The following lab values obtained ≤ 28 days prior to pre-registration:\n\n  * Hemoglobin ≥ 9.0 g\u002FdL (Must be ≥ 7 days after most recent transfusion)\n  * Absolute neutrophil count (ANC) ≥ 1500\u002Fmm\\^3 or ≥ 1.5 X 10\\^9\u002FL\n  * Platelet count ≥ 100,000\u002Fmm\\^3 or ≥ 100 X 10\\^9\u002FL (Must be ≥7 days after most recent transfusion)\n  * Total bilirubin ≤ 1.5 x upper limit of normal (ULN)\n  * Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 x ULN or ≤ 5 x ULN with liver metastases\n  * Creatinine ≤ 1.5 x ULN OR calculated creatinine clearance must be ≥ 50 ml\u002Fmin using Cockcroft-Gault formula\n  * International normalized ratio (INR) or prothrombin time (PT) and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN unless patient is receiving anticoagulant therapy in which case PT or PTT must be within target range of therapy\n\nPHASE I REGISTRATION, ALL:\n\n* Successful sequencing and production of REAL-Neo vaccine\n* Measurable disease as defined by RECIST (v 1.1) criteria or non-measurable disease\n\n  * NOTE: Tumor lesions in previously irradiated area are not considered measurable disease\n* ECOG PS 0 or 1\n* Anticipated life expectancy \\> 6 months\n* The following lab values obtained ≤ 14 days prior to registration:\n\n  * Hemoglobin ≥ 9.0 g\u002Fdl\n  * ANC ≥ 1500\u002Fmm\\^3\n  * Platelet count ≥ 100,000\u002Fmm\\^3\n  * Total bilirubin ≤ 1.5 x ULN\n  * ALT and AST ≤ 3 x ULN (≤ 5 x ULN with liver involvement)\n  * PT\u002FINR and aPTT ≤ 1.5 x ULN unless patient is receiving anticoagulant therapy in which case INR or aPTT must be within target range of therapy\n  * Calculated creatinine clearance ≥ 50 ml\u002Fmin using Cockcroft-Gault formula\n* Provide written informed consent\n* Willing to provide blood and tissue specimens for research\n* Willing to return to enrolling institution for follow-up\n* Patients with actionable genomic abnormality including, but not limited to EGFR, ALK, MET, ROS-1, RET, NTRK, KRAS or BRAF must have also received and progressed on at least one line of prior FDA-approved targeted therapy\n* Negative pregnancy test ≤ 14 days prior to registration for persons of childbearing potential only\n\n  * NOTE: If urine test cannot be confirmed negative, serum pregnancy test will be required\n* Willing to employ highly effective method of contraception from pre-registration through 6 months after final vaccine cycle\n* Willing to receive tetanus vaccination if subject has not had one ≤ 1 year prior to pre-registration\n* Recovered from all toxicities associated with prior treatment to acceptable baseline status or NCI CTCAE v5 Grade of 0 or 1, except for toxicities not considered safety risk per treating investigator (e.g., alopecia or vitiligo)\n\nPHASE II PRE-SCREENING COHORT 3 ONLY:\n\n* ECOG PS 0 or 1\n* Histological confirmation of adenocarcinoma of the breast with estrogen receptor (ER) \\\u003C 10%, progesterone receptor (PR) \\\u003C 10%, and HER2 negative based on current American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guideline\n* Stage I-III based on 7th edition of TNM staging system from American Joint Committee on Cancer (AJCC)\n* Evidence of residual disease ≥ 1 cm after neoadjuvant pembrolizumab-based chemotherapy on imaging for patients who have not had surgery\n* Willing to proceed with surgery and provide tissue and blood specimens for patients who have not had surgery, willing to provide clinically collected FFPE tissue blocks, or willing to provide available sequencing data available from commercial or research test\n* Provide written informed consent\n* Willing to return to enrolling institution for follow-up\n\nPHASE II PRE-SCREENING COHORT 4 ONLY:\n\n* ECOG PS 0 or 1\n* Histological confirmation of lung NSCLC\n* No actionable EGFR mutations and ALK fusions\n* Stage II or stage III based on AJCC 8th\n* Tumor ≥ 2 cm on pre-surgery evaluation imaging (residual disease ≥ 2 cm after neoadjuvant therapy on pre-surgery evaluation imaging in patient who receives neoadjuvant therapy) for patients who have not had surgery. Patients with or without neoadjuvant chemotherapy or immunotherapy are allowed\n* Provide written informed consent\n* Willing to proceed with surgery and provide tissue and blood specimens for patients who have not had surgery\n* Willing to return to enrolling institution for follow-up\n\nPHASE II PRE-REGISTRATION COHORT 3 (TNBC) ONLY:\n\n* Histologically confirmed residual cancer burden 2 and 3 in surgical specimens\n\nPHASE II PRE-REGISTRATION COHORT 4 (NSCLC) ONLY:\n\n* Tumor without complete pathologic response is confirmed in pathology\n* Willing to employ highly effective method of contraception from pre-registration through 6 months after final vaccine cycle\n* ECOG PS of 0 or 1\n* Anticipated life expectancy \\> 6 months\n\nPHASE II PRE-REGISTRATION PILOT AND COHORT 5:\n\n* Provide written informed consent. For pediatric patients (age 16-17 years):\n\n  * Written informed consent from legal guardian(s) and\u002For child obtained in accordance with local regulations\n* Willing to proceed with surgery and provide mandatory tissue specimens or previously collected FFPE tissues for complete exome and transcriptome sequencing or available sequencing data available from commercial or research test\n\n  * NOTE: Patients who had sequencing under Mayo IRB protocol #13-000942, #14-004094, or #21-007742 and neoantigens have been identified or REAL Neo vaccine produced are allowed to proceed to pre-registration and\u002For registration\n* Negative pregnancy test done ≤ 7 days prior to pre-registration for persons of childbearing potential only\n\n  * NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Willing to employ a highly effective method of contraception from the time of preregistration through 6 months after the final vaccine cycle\n* ECOG performance status of 0 or 1\n* Anticipated life expectancy of \\> 6 months\n* Willing to return to enrolling institution for follow-up\n\nPHASE II PRE-REGISTRATION COHORT 5 (ILC) ONLY:\n\n* Histologically confirmed invasive lobular carcinoma or other histology with lobular features\n\n  * Histological confirmation of adenocarcinoma of the breast with invasive lobular histology or other histology with lobular features with any estrogen receptor (ER), progesterone receptor (PR), and HER2 status\n  * Stage II-IV based on the 7th edition of TNM staging system from AJCC\n  * Tumor mutational burden ≥ 10 muts\u002FMb either in tissue or blood\n\nPHASE II AND PILOT COHORT 5 REGISTRATION:\n\n* Successful sequencing and production of REAL-Neo vaccine\n* Patients will receive ≥ 2 additional cycles of maintenance pembrolizumab\n* ECOG PS 0 or 1\n* Anticipated life expectancy \\> 6 months\n* Lab values as per Phase I registration criteria obtained ≤ 14 days prior to registration:\n* Provide written informed consent\n* Willing to provide blood specimens for research\n* Willing to return to enrolling institution for follow-up\n* Negative pregnancy test ≤ 14 days prior to registration for persons of childbearing potential only. If urine test cannot be confirmed negative, serum pregnancy test will be required.\n* Willing to employ highly effective method of contraception from pre-registration through 6 months after final vaccine cycle\n* Willing to receive tetanus vaccination if subject has not had one ≤ 1 year prior registration\n* Recovered from all toxicities associated with prior treatment to acceptable baseline status NCI CTCAE v5 grade of 0 or 1, except for toxicities not considered safety risk per treating investigator (e.g., alopecia or vitiligo)\n\nExclusion Criteria\n\nALL PHASES:\n\n* Any of the following because study involves investigational agent whose genotoxic, mutagenic and teratogenic effects on developing fetus and newborn are unknown:\n\n  * Pregnant person\n  * Nursing person unwilling to stop breast feeding\n  * Person of childbearing potential unwilling to employ adequate contraception from registration through 6 months after final vaccine cycle\n* Co-morbid systemic illnesses or other severe concurrent disease which, in judgment of investigator, would make patient inappropriate for entry into this study or interfere significantly with proper assessment of safety and toxicity of prescribed regimens\n* History of myocardial infarction ≤ 6 months prior to pre-registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias.\n* Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy\n\nPHASE I PRE-REGISTRATION:\n\n* Acute, reversible effect(s) of prior therapy not recovered to baseline regardless of interval since last treatment\n* Uncontrolled illness including, but not limited to:\n\n  * Ongoing or active infection\n  * Psychiatric illness\u002Fsocial situations\n  * Congestive heart failure with New York Heart Association (NYHA) class III or IV moderate to severe objective evidence of cardiovascular disease\n  * Stroke ≤ 3 months prior to pre-registration\n  * Significant cardiac arrhythmia or unstable angina\n  * Any other conditions that would limit compliance with study requirements\n* Receiving any other investigational agent which would be considered treatment for primary neoplasm, except pembrolizumab\n* Any prior hypersensitivity or adverse reaction to GM-CSF\n* Other active malignancy ≤ 3 years prior to pre-registration\n\n  * EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix\n  * NOTE: If there is history of prior malignancy, they must not be receiving other specific treatment for their cancer\n* History of active autoimmune disease (AD) that required systemic treatment in ≤ 30 days (i.e., use of disease modifying agents, corticosteroids \\> 10 mg daily prednisone equivalent, or other immunosuppressive drugs) prior to pre-registration\n\n  * NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered systemic treatment. Patients with vitiligo, Graves disease, or psoriasis not requiring systemic treatment within the past 30 days are not excluded. Patients with celiac disease controlled with diet modification are not excluded PHASE I REGISTRATION\n* Any of the following prior therapies:\n\n  * Chemotherapy, experimental drugs (except pembrolizumab), or small molecules inhibitors (except for endocrine therapies) ≤ 3 weeks prior to cycle 1 day 1 (C1D1) neoantigen vaccinations\n  * Radiation ≤ 2 weeks prior to C1D1 neoantigen vaccinations\n  * Major Surgery ≤ 4 weeks prior to C1D1 neoantigen vaccinations\n  * Received live vaccine ≤ 30 days prior to C1D1 neoantigen vaccinations\n  * NOTE: Palliative radiation therapy for symptoms control including, but not limited to, bone metastatic lesion radiation therapy is allowed, but last dose of radiation therapy should be \\> 14 days from first dose of vaccination on study\n* CTCAE ≥ Grade 3 treatment-emergent adverse event (TEAE) to prior checkpoint inhibitor, TEAE requiring systemic corticosteroids (\\> 10 mg daily prednisone equivalent), or permanent treatment discontinuation due to toxicity\n* Neuromuscular disorders (e.g. inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis and spinal muscular atrophy) or history of rhabdomyolysis\n* Active ADs that require chronic systemic steroids (\\> 10 mg daily prednisone equivalent) or immunosuppressive agents\n* Systemic corticosteroids (\\> 10 mg daily prednisone equivalent) or other immunosuppressive medications ≤ 14 days prior to registration\n\n  * NOTE: Inhaled or topical steroids and adrenal replacement steroid doses \\> 10 mg daily prednisone equivalent permitted in absence of active AD\n* Patients will also be excluded based on tissue\u002FRNA\u002FDNA quality and quantity. If any of the following quality and quantity thresholds are not met, the patient will be excluded:\n\n  * Tumor tissue cellularity ≥ 30%\n  * Sufficient tissue (fresh frozen or FFPE) for both DNA and RNA sequencing with passing cellularity.\n  * ≥ 30% of tumor RNA with fragment sizes are ≥ 200 base pairs (DV200 ≥ 30)\n  * \\\u003C 10% of DNA fragments are smaller than 1 kb\n  * Sufficient amount of both DNA (blood and tumor) and RNA (tumor) for exome sequencing and RNAseq according to the Mayo sequencing core (note: kits and technologies change over time, so these are not fixed numbers)\n* Evidence of leptomeningeal disease or central nervous system metastases that are untreated, symptomatic, or require steroids \\>10 mg daily prednisone equivalent\n\n  * NOTE: Patients with history of stable treated brain metastases are eligible. Stable treated metastases defined as no evidence of progression for ≥4 weeks on brain imaging (MRI or CT scan)\n\nPHASE II PRE-SCREENING:\n\n* Uncontrolled illness including, but not limited to:\n\n  * Ongoing or active infection\n  * CHF with NYHA class III or IV; moderate to severe objective evidence of cardiovascular disease\n  * Significant cardiac arrhythmia or unstable angina\n  * Any other conditions that would limit compliance with study requirements\n* Any prior hypersensitivity or adverse reaction to GM-CSF\n* Other active malignancy ≤ 3 years prior to pre-screening\n\n  * EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix\n  * NOTE: If there is history of prior malignancy, they must not be receiving other specific treatment for their cancer\n* Known history of active AD that has required systemic treatment in the ≤ 30 days (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) prior to pre-screening\n\n  * NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered systemic treatment. Patients with vitiligo, Graves' disease, or psoriasis not requiring systemic treatment within the past 30 days are not excluded. Patients with Celiac disease controlled with diet modification are not excluded.\n\nPHASE II PRE-REGISTRATION\n\n* Uncontrolled illness including, but not limited to:\n\n  * Congestive heart failure with NYHA class III or IV; moderate to severe objective evidence of cardiovascular disease\n  * Significant cardiac arrhythmia or unstable angina\n  * Any other conditions that would limit compliance with study requirements\n* Any prior hypersensitivity or adverse reaction to GM-CSF\n* Other active malignancy ≤ 3 years prior to pre-registration\n\n  * EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix\n  * NOTE: If history of prior malignancy, must not be receiving other specific treatment for cancer\n* Known history of active AD that has required systemic treatment in the ≤ 30 days (i.e., with use of disease modifying agents, corticosteroids \\> 10 mg daily prednisone equivalent, or other immunosuppressive drugs) prior to pre-registration\n\n  * NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid therapy for adrenal or pituitary insufficiency) is not considered systemic treatment. Patients with vitiligo, Graves' disease, or psoriasis not requiring systemic treatment within the past 30 days are not excluded. Patients with Celiac disease controlled with diet modification are not excluded.\n* Patients will also be excluded based on tissue\u002FRNA\u002FDNA quality and quantity. If any of the following quality and quantity thresholds are not met, patient will be excluded: (1) tumor tissue cellularity equal to or greater than 30%; (2) there are ≥ 2 cores with passing cellularity; (3) ≥ 30% of tumor RNA with fragment sizes are ≥ 200 base pairs (DV200 ≥ 30); (4) \\\u003C 10% of DNA fragments are smaller than 1 kb; and (5) sufficient amount of both DNA (blood and tumor) and RNA (tumor) for exome sequencing and whole transcriptome sequencing (RNAseq) according to Mayo sequencing core. (Kits and technologies change overtime, so these are not fixed numbers.)\n\nPHASE II REGISTRATION\n\n* Evidence of metastatic disease or recurrence\n* Any of the following prior therapies:\n\n  * Chemotherapy, experimental drugs (except pembrolizumab), or small molecules inhibitors (except for endocrine therapies) ≤ 3 weeks prior to study treatment\n  * Radiation ≤ 2 weeks prior to study treatment\n  * Major surgery ≤ 4 weeks prior to study treatment\n  * Received live vaccine ≤ 30 days prior to study treatment\n\n    * NOTE: Continuation of pembrolizumab per standard of care is allowed\n    * NOTE: Palliative radiation therapy for symptoms control including, but not limited to, bone metastatic lesion radiation therapy is allowed, but last dose of radiation therapy should be \\> 14 days from first dose of vaccination on study\n* CTCAE ≥ grade 3 TEAE to prior checkpoint inhibitor, TEAE requiring systemic corticosteroids (\\> 10 mg daily prednisone equivalent), or permanent treatment discontinuation due to toxicity\n* Neuromuscular disorders (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis and spinal muscular atrophy), or history of rhabdomyolysis\n* Active ADs that require chronic systemic steroids (\\> 10 mg daily prednisone equivalent) or immunosuppressive agents\n\nOther inclusion\u002Fexclusion criteria as indicated per protocol not listed here due to limitation in number of characters (text) allowed.","ALL","16 Years",{"count":20,"type":21},138,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This phase I\u002FII trial tests the safety and tolerability of an experimental personalized vaccine when given by itself and with pembrolizumab in treating patients with solid tumor cancers that have spread to other places in the body (advanced). The experimental vaccine is designed target certain proteins (neoantigens) on individuals' tumor cells. 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. Giving the personalized neoantigen peptide-based vaccine with pembrolizumab may be safe and effective in treating patients with advanced solid tumors.",[28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128],"Anatomic Stage III Breast Cancer AJCC v8","Anatomic Stage IIIA Breast Cancer AJCC v8","Anatomic Stage IIIB Breast Cancer AJCC v8","Anatomic Stage IIIC Breast Cancer AJCC v8","Anatomic Stage IV Breast Cancer AJCC v8","Clinical Stage III Cutaneous Melanoma AJCC v8","Clinical Stage III Gastric Cancer AJCC v8","Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8","Clinical Stage III Merkel Cell Carcinoma AJCC v8","Clinical Stage IV Cutaneous Melanoma AJCC v8","Clinical Stage IV Gastric Cancer AJCC v8","Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8","Clinical Stage IV Merkel Cell Carcinoma AJCC v8","Clinical Stage IVA Gastric Cancer AJCC v8","Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8","Clinical Stage IVB Gastric Cancer AJCC v8","Clinical Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8","Locally Advanced Cervical Carcinoma","Locally Advanced Endometrial Carcinoma","Locally Advanced Gastric Adenocarcinoma","Locally Advanced Gastroesophageal Junction Adenocarcinoma","Locally Advanced Head and Neck Squamous Cell Carcinoma","Locally Advanced Hepatocellular Carcinoma","Locally Advanced Lung Non-Small Cell Carcinoma","Locally Advanced Malignant Solid Neoplasm","Locally Advanced Melanoma","Locally Advanced Merkel Cell Carcinoma","Locally Advanced Renal Cell Carcinoma","Locally Advanced Skin Squamous Cell Carcinoma","Locally Advanced Triple-Negative Breast Carcinoma","Locally Advanced Unresectable Breast Carcinoma","Locally Advanced Unresectable Cervical Carcinoma","Locally Advanced Unresectable Gastric Adenocarcinoma","Locally Advanced Unresectable Gastroesophageal Junction Adenocarcinoma","Locally Advanced Unresectable Renal Cell Carcinoma","Locally Advanced Urothelial Carcinoma","Metastatic Cervical Carcinoma","Metastatic Endometrial Carcinoma","Metastatic Gastric Adenocarcinoma","Metastatic Gastroesophageal Junction Adenocarcinoma","Metastatic Head and Neck Squamous Cell Carcinoma","Metastatic Hepatocellular Carcinoma","Metastatic Lung Non-Small Cell Carcinoma","Metastatic Malignant Solid Neoplasm","Metastatic Melanoma","Metastatic Merkel Cell Carcinoma","Metastatic Renal Cell Carcinoma","Metastatic Skin Squamous Cell Carcinoma","Metastatic Triple-Negative Breast Carcinoma","Metastatic Urothelial Carcinoma","Skin Squamous Cell Carcinoma","Stage III Cervical Cancer AJCC v8","Stage III Hepatocellular Carcinoma AJCC v8","Stage III Lung Cancer AJCC v8","Stage III Renal Cell Cancer AJCC v8","Stage IIIA Cervical Cancer AJCC v8","Stage IIIA Hepatocellular Carcinoma AJCC v8","Stage IIIA Lung Cancer AJCC v8","Stage IIIA Uterine Corpus Cancer AJCC v8","Stage IIIB Cervical Cancer AJCC v8","Stage IIIB Hepatocellular Carcinoma AJCC v8","Stage IIIB Lung Cancer AJCC v8","Stage IIIB Uterine Corpus Cancer AJCC v8","Stage IIIC Lung Cancer AJCC v8","Stage IIIC Uterine Corpus Cancer AJCC v8","Stage IIIC1 Uterine Corpus Cancer AJCC v8","Stage IIIC2 Uterine Corpus Cancer AJCC v8","Stage IV Cervical Cancer AJCC v8","Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8","Stage IV Hepatocellular Carcinoma AJCC v8","Stage IV Lung Cancer AJCC v8","Stage IV Renal Cell Cancer AJCC v8","Stage IVA Cervical Cancer AJCC v8","Stage IVA Hepatocellular Carcinoma AJCC v8","Stage IVA Lung Cancer AJCC v8","Stage IVA Uterine Corpus Cancer AJCC v8","Stage IVB Cervical Cancer AJCC v8","Stage IVB Hepatocellular Carcinoma AJCC v8","Stage IVB Lung Cancer AJCC v8","Stage IVB Uterine Corpus Cancer AJCC v8","Triple-Negative Breast Carcinoma","Unresectable Cervical Carcinoma","Unresectable Endometrial Carcinoma","Unresectable Gastric Adenocarcinoma","Unresectable Gastroesophageal Junction Adenocarcinoma","Unresectable Head and Neck Squamous Cell Carcinoma","Unresectable Hepatocellular Carcinoma","Unresectable Lung Non-Small Cell Carcinoma","Unresectable Malignant Solid Neoplasm","Unresectable Melanoma","Unresectable Merkel Cell Carcinoma","Unresectable Renal Cell Carcinoma","Unresectable Skin Squamous Cell Carcinoma","Unresectable Triple-Negative Breast Carcinoma","Unresectable Urothelial Carcinoma","Breast Adenocarcinoma","Stage III Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8","Stage IV Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8","Stage III Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8","Stage IV Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8","Invasive Breast Lobular Carcinoma","RECRUITING","2026-08-18",{"date":132,"type":133},"2026-08-20","ACTUAL",{"date":135,"type":133},"2022-03-31",{"date":137,"type":21},"2028-03-31",{"name":139,"class":140},"Mayo Clinic","OTHER",1,{"id":143,"slug":144,"hasResults":11,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":4,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":17,"minAge":149,"maxAge":4,"enrollmentInfo":150,"targetDuration":4,"studyType":22,"phases":152,"briefSummary":153,"conditions":154,"keywords":4,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":167},"100447832","testing-the-combination-of-the-anticancer-drugs-zen003694-and-binimetinib-in-patients-with-advancedmetastatic-or-unresectable-solid-tumors-with-ras-alterations-and-triple-negative-breast-cancer-100447832","NCT05111561","Testing the Combination of the Anticancer Drugs ZEN003694 and Binimetinib in Patients With Advanced\u002FMetastatic or Unresectable Solid Tumors With RAS Alterations and Triple Negative Breast Cancer","A Phase 1 Study of ZEN003694 in Combination With Binimetinib in Solid Tumors With RAS Pathway Alterations and Triple Negative Breast Cancer","Inclusion Criteria:\n\n* Patients must have histologically confirmed advanced\u002Fmetastatic or unresectable solid tumor that is refractory to standard therapy or has relapsed after standard therapy\n* Patients must have one of the following:\n\n  * For Part 1 and 2 -\n\n    * Triple negative breast cancer (TNBC) (estrogen receptor =\\\u003C 1%, progesterone receptor =\\\u003C 1%, human epidermal growth factor receptor 2 0-1+ or non-amplified)\n    * Solid tumor with genomic alteration(s) activating RAS signaling including activating KRAS, NRAS, HRAS, or BRAF mutations, inactivating NF1 mutations, or BRAF fusions\n\n      * Genomic alterations should be identified locally by next generation sequencing (NGS). Patient genomic reports will be reviewed by the MD Anderson Cancer Center (MDACC) Precision Oncology Decision Support team prior to initiation of study treatment\n* For Part 1, patients can have evaluable or measurable disease. For Part 2, patients must have measurable disease by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1\n* Patients must be \\>= 4 weeks beyond treatment with any chemotherapy (6 weeks for nitrosoureas or mitomycin C) or other investigational therapy to include hormonal, biological, or targeted agents; or at least 5 half-lives from hormonal, biological, or targeted agents, whichever is shorter at the time of study treatment initiation. Patients must be \\>= 4 weeks beyond radiotherapy\n* Age \\>= 18 years. Because no dosing or adverse events (AE) data are currently available on the use of binimetinib and ZEN003694 (ZEN-3694) in patients \\\u003C 18 years of age, children are excluded from this study\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2 (Karnofsky \\>= 60%)\n* Absolute neutrophil count \\>= 1,500\u002FmcL\n* Platelets \\>= 125,000\u002FmcL\n* Hemoglobin \\>= 8 g\u002FdL or \\>= 5.6 mmol\u002FL\n* Total bilirubin =\\\u003C 1.5 x institutional upper limit of normal (ULN) OR \\\u003C 2.0 x ULN in patients with documented Gilbert's syndrome\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 2.5 x institutional ULN\n* Calculated creatinine clearance \\>= 60 mL\u002Fmin\u002F1.73 m\\^2 (based on the calculated Chronic Kidney Disease-Epidemiology collaboration \\[CKD-EPI\\] glomerular filtration rate estimation)\n* Prothrombin time =\\\u003C 1.5 x ULN\n* Partial thromboplastin time =\\\u003C 1.5 x ULN\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this study\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* 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* Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no 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 at least 7 days prior to the first dose of study treatment. This exception does not include carcinomatous meningitis and primary CNS cancers, which are excluded regardless of clinical stability\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 study\n* Patients should be New York Heart Association Functional Classification of class 2B or better\n* Patients must have corrected QT (QTcF) \\\u003C 450 msec\n* The effects of ZEN003694 (ZEN-3694) and binimetinib on the developing human fetus are unknown. For this reason and because BETi agents are known to be teratogenic, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and 4 months after the completion of ZEN003694 (ZEN-3694) and binimetinib administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of ZEN003694 (ZEN-3694) and binimetinib administration\n* Ability to understand and the willingness to sign a written informed consent document. Participants with impaired decision-making capacity who have a legally authorized representative (LAR) and\u002For family member available will also be eligible\n\nExclusion Criteria:\n\n* Patients who have not recovered from adverse events (AEs) due to prior anticancer therapy (i.e., have residual toxicities \\> Grade 1) with the exception of alopecia, peripheral neuropathy, and endocrinopathy managed with replacement therapy before the initiation of study treatment\n* Patients who are receiving any other investigational agents\n* Breast cancer patients with a prior history of hormone receptor positivity will not be eligible\n* Patients with known PI3K pathway activating genomic alterations including inactivating mutations\u002Fdeletions in PTEN and PIK3R1, amplifications in PIK3CA, and activating mutations in PIK3CA, Akt, or mTOR will not be eligible\n* Prior therapy with BET, RAF, MEK, or ERK inhibitor\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to ZEN003694 (ZEN-3694) and binimetinib\n* Patients requiring therapeutic doses of anticoagulation are excluded. Patients taking low-dose (prophylactic) anticoagulation (e.g., low-molecular weight heparin, low-dose warfarin, fondaparinux) are allowed. Patients receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 are ineligible. Strong inhibitors or inducers of CYP3A4 must be discontinued at least 7 days prior to the first dose of ZEN003694. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently updated medical reference (https:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fdrug-interactions-labeling\u002Fdrug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers). As part of the enrollment\u002Finformed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product\n* Patients with uncontrolled intercurrent illness\n* Patients with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Pregnant women are excluded from this study because ZEN003694 (ZEN-3694) and binimetinib are a BETi and MEK inhibitor agent, respectively, with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for AEs in nursing infants secondary to treatment of the mother with ZEN003694 (ZEN-3694) and binimetinib, breastfeeding should be discontinued if the mother is treated with ZEN003694 (ZEN-3694) and binimetinib\n* Patient has a history of cerebrovascular accident, myocardial infarction, or unstable angina within the previous 6 months prior to study treatment initiation\n* Patients with any medical condition or diagnosis that would likely impair absorption of an orally administered drug (e.g., gastrectomy, ileal bypass, chronic diarrhea, gastroparesis) are excluded\n* Patient has a history of retinal vein occlusion\n* Patient has a history of pneumonitis or interstitial lung disease","18 Years",{"count":151,"type":21},42,[24],"This phase I trial tests the safety, side effects, and best dose of ZEN003694 in combination with binimetinib in treating patients with solid tumors that carry RAS alterations and that have spread to other places in the body (advanced\u002Fmetastatic) or cannot be removed by surgery (unresectable). ZEN003694 is an oral medication with potential anticancer activity. It is an inhibitor of a family of proteins called bromodomain and extra-terminal (BET) which play important role during development and cellular growth. ZEN003694 may stop the growth of tumor cells that produce BET. Binimetinib is in a class of medications called kinase inhibitors. It works by blocking the action proteins called MEK1 and MEK2, that signal cancer cells to multiply. It may help keep cancer cells from growing and spreading. There is pre-clinical evidence that using ZEN003694 and binimetinib together may shrink or stabilize cancers studied in this trial. There are two parts of this study; dose escalation and dose expansion. In the dose escalation part of this study, different people will get different doses of the study drugs ZEN003694 and binimetinib. In the dose expansion part of this study, the highest dose with manageable side effects will be given to additional people. This will help to understand the side effects that may happen with this drug combination.",[155,71,156,108,116],"Advanced Malignant Solid Neoplasm","Refractory Malignant Solid Neoplasm","2026-08-07",{"date":159,"type":133},"2026-08-10",{"date":161,"type":133},"2022-08-02",{"date":163,"type":21},"2027-03-14",{"name":165,"class":166},"National Cancer Institute (NCI)","NIH",4,{"id":169,"slug":170,"hasResults":11,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":4,"eligibilityCriteria":174,"healthyVolunteers":11,"sex":175,"minAge":149,"maxAge":4,"enrollmentInfo":176,"targetDuration":4,"studyType":22,"phases":178,"briefSummary":180,"conditions":181,"keywords":4,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":5},"100650009","a-blended-e-health-intervention-to-improve-fear-of-progression-in-women-with-gynecologic-or-breast-cancer-100650009","NCT07741968","A Blended e-Health Intervention to Improve Fear of Progression in Women With Gynecologic or Breast Cancer","An e-Health Intervention for Fear of Progression in Women With Gynecologic or Breast Cancer","Inclusion Criteria:\n\n* Women with stage III or IV GYN (ovarian, endometrial, cervical, vulvar\u002Fvaginal) or breast cancer who are at least 2 months from initial diagnosis OR Women with stage I or II endometrial, ovarian, or breast cancer with carcinosarcoma histology OR Women with stage I or II triple negative breast cancer\n* Score ≥ 34 on the Fear of Progression Short-Form, indicating dysfunctional levels\n* Age 18 or older; able to read and understand English\n* Patients can be on active treatment or surveillance. They can be no evidence of disease (NED), recurrent or with progressive disease\n\nExclusion Criteria:\n\n* Enrolled in hospice\n* Ongoing uncontrolled active psychiatric condition that, in the opinion of the investigator, would interfere in the conduct of the study (e.g., mood disorders, psychosis disorders, or substance use), Major depression as assessed by Patient Health Questionnaire-9 (PHQ-9)\n* Non-English speaking\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)\n* Current participation in a mind-body or mindfulness education program within the past six weeks","FEMALE",{"count":177,"type":21},126,[179],"NA","This clinical trial studies whether an intervention supported by technology (blended e-health intervention) works to improve fear of progression (FOP) in women with gynecologic or breast cancer. FOP is the fear patients experience from the possibility that their cancer could grow, spread, or get worse. Managing FOP is a leading unmet concern of cancer patients. High levels of FOP are associated with distress, depression, and increased health care costs, despite this, access to resources to address FOP remain limited. The blended e-health intervention in this trial offers remote group sessions along with online sessions to help patients access the information. Session content incorporates values-based goal setting and skills practices to manage unhelpful beliefs about worry and promote helpful coping behaviors. The sessions may help patients recognize unhelpful thoughts and behaviors which reinforce worry. A blended e-health intervention may be an effective way to improve FOP in women with gynecologic or breast cancer.",[182,183,28,32,184,185,186,187,188,189,79,190,191,95,192,193,108,194],"Anatomic Stage I Breast Cancer AJCC v8","Anatomic Stage II Breast Cancer AJCC v8","Breast Carcinoma","Breast Mixed Epithelial\u002FMesenchymal Metaplastic Carcinoma","Endometrial Carcinoma","Malignant Female Reproductive System Neoplasm","Ovarian Carcinoma","Ovarian Carcinosarcoma","Stage III Vaginal Cancer AJCC v8","Stage III Vulvar Cancer AJCC v8","Stage IV Vaginal Cancer AJCC v8","Stage IV Vulvar Cancer AJCC v8","Uterine Corpus Carcinosarcoma","2026-08-06",{"date":159,"type":133},{"date":198,"type":21},"2027-02-22",{"date":200,"type":21},"2028-01-16",{"name":202,"class":140},"City of Hope Medical Center",{"id":204,"slug":205,"hasResults":11,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":4,"eligibilityCriteria":209,"healthyVolunteers":11,"sex":17,"minAge":149,"maxAge":4,"enrollmentInfo":210,"targetDuration":4,"studyType":22,"phases":212,"briefSummary":213,"conditions":214,"keywords":4,"overallStatus":215,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":141},"100648454","phase-2-a-vaccine-stemvac-for-improving-survival-in-patients-with-triple-negative-breast-cancer-and-moderate-or-extensive-residual-cancer-burden-100648454","NCT07721259","A Vaccine (STEMVAC) for Improving Survival in Patients With Triple-Negative Breast Cancer and Moderate or Extensive Residual Cancer Burden","A Multiantigen Vaccine (STEMVAC) for Adjuvant Treatment of Patients With Moderate or Extensive Residual Triple-Negative Breast Cancer","Inclusion Criteria:\n\n* At least 18 years of age\n* Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 2\n* Triple-negative breast cancer as determined by the treating oncologist\n* Completed standard of care neoadjuvant chemotherapy in the opinion of their treating oncologist\n* Patients whose tumors progress on neoadjuvant therapy may be enrolled\n* No clinical evidence of local or distant recurrence\n* Plan to receive standard of care adjuvant directed therapy\n* Completed standard of care locoregional treatment, including definitive breast and lymph node surgery followed by standard radiation therapy, if recommended\n* Residual cancer burden (RCB) index 2 or 3 as calculated per routine anatomic pathology clinical standards\n* Absolute neutrophil count (ANC) ≥ 800\u002FμL (within 30 days of first study vaccine administration)\n* Hemoglobin (Hgb) ≥ 8 g\u002FdL (within 30 days of first study vaccine administration)\n* Platelets ≥ 75,000\u002F μL (within 30 days of first study vaccine administration)\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN), except patients with Gilbert's syndrome, in whom total bilirubin must be \\\u003C 3.0 mg\u002FdL (within 30 days of first study vaccine administration)\n* Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) ≤ 1.5 x institutional ULN (within 30 days of first study vaccine administration)\n* Creatinine ≤ 1.5 x ULN mg\u002FdL or creatinine clearance \\> 60 mL\u002Fmin (within 30 days of first study vaccine administration)\n* At least 28 days post systemic steroids prior to enrollment, unless used as part of prophylaxis to prevent intravenous (IV) contrast reactions.\n\n  * Topical, ocular, intra-articular, intranasal, inhalational corticosteroids (with minimal systemic absorption) are allowed\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* 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 person of child-bearing potential. Acceptable methods of contraception are abstinence, condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or post-menopausal\n\nExclusion Criteria:\n\n* Toxicities related to prior exposure to immune checkpoint inhibitors for which immune checkpoint inhibitors cannot be safely continued as determined by study investigator\n* Germline BRCA1 or BRCA2 mutations with adjuvant olaparib planned within the study period\n\n  * NOTE: If olaparib is not planned, then these patients are eligible\n* Any known 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* Autoimmune disease requiring active systemic treatment\n* Known hypersensitivity reaction to the 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\\] is detected)\n* Major surgery within the 4 weeks prior to initiation of first study vaccine\n* Enrollment in any other clinical protocol or investigational trial that involves concurrent administration of experimental therapy and\u002For therapeutic devices, or investigational drug. Patients who completed prior clinical trials (such as neoadjuvant treatment, surgery or radiation trials) and are on long term follow up are permitted",{"count":211,"type":21},60,[25],"This phase II trial evaluates whether a multi-antigen vaccine called STEMVAC improves disease-free survival after surgery in patients with triple-negative breast cancer (TNBC) and moderate or extensive residual cancer burden. TNBC has an aggressive clinical course and poorer disease-free survival compared to other subtypes. While patients who have no remaining tumor in the breast or lymph nodes after surgery have excellent long-term outcomes, patients with moderate or extensive residual cancer burden remain at high risk for early disease return and poorer prognosis. STEMVAC is designed to target proteins that tumor 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. Giving STEMVAC after surgery may improve disease-free survival rates in TNBC patients with moderate or extensive residual cancer burden.",[182,183,28,108],"NOT_YET_RECRUITING","2026-07-17",{"date":218,"type":133},"2026-07-23",{"date":220,"type":21},"2026-09-30",{"date":222,"type":21},"2030-07-16",{"name":224,"class":140},"University of Washington",{"id":226,"slug":227,"hasResults":11,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":4,"eligibilityCriteria":231,"healthyVolunteers":11,"sex":175,"minAge":149,"maxAge":4,"enrollmentInfo":232,"targetDuration":4,"studyType":22,"phases":234,"briefSummary":235,"conditions":236,"keywords":4,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":248},"100491336","feasibility-study-of-biobehavioral-stress-reduction-intervention-in-patients-with-triple-negative-breast-cancer-100491336","NCT05677802","Feasibility Study of Biobehavioral Stress Reduction Intervention in Patients With Triple Negative Breast Cancer","Examining the Feasibility of Implementing a Biobehavioral Stress Reduction Program in Triple Negative Breast Cancer Patients","Inclusion Criteria:\n\n* Age \\>=18 years\n* Untreated newly diagnosed triple negative breast cancer\n* Stages I-III\n\nExclusion Criteria:\n\n* Prisoners\n* Male\n* Identifying as American Indian, Alaska Native, Asian, Native Hawaiian or Other Pacific Islander\n* Individuals not able to speak and understand English\n* Known personal history of ductal carcinoma in situ (DCIS) or invasive breast cancer\n* Stage IV breast cancer",{"count":233,"type":21},40,[179],"This clinical trial aims to see if patients with triple negative breast cancer can complete a biobehavioral stress reduction program that also addresses health related social needs (e.g., utilities, transportation, etc.). The stress reduction program is over ten weeks and includes stress reduction (e.g., progressive muscle relaxation), coping, problem solving, communication, and social support. Health related social needs will be evaluated at the beginning of the study, and referrals will be made to social work to help address those needs. The study will examine stress as reported by the patients and also use biological markers.",[182,183,28,237,238,108],"HER2-Negative Breast Carcinoma","Hormone Receptor-Negative Breast Carcinoma","2026-06-24",{"date":241,"type":133},"2026-06-29",{"date":243,"type":133},"2022-12-14",{"date":245,"type":21},"2027-06-30",{"name":247,"class":140},"Ohio State University Comprehensive Cancer Center",2,{"id":250,"slug":251,"hasResults":11,"nctId":252,"briefTitle":253,"officialTitle":254,"acronym":4,"eligibilityCriteria":255,"healthyVolunteers":256,"sex":17,"minAge":149,"maxAge":4,"enrollmentInfo":257,"targetDuration":4,"studyType":22,"phases":259,"briefSummary":260,"conditions":261,"keywords":4,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":248},"100548550","access-to-genetic-testing-in-underserved-patients-with-cancer-100548550","NCT06422455","Access to Genetic Testing in Underserved Patients With Cancer","Increasing Access to Genetic Testing in Underserved Patients Using a Multilingual Conversational Agent","Inclusion Criteria:\n\n* Age \\> 18 years old\n* Diagnosed with least one of the following:\n\n  * Epithelial ovarian cancer\n  * Exocrine pancreatic cancer\n  * Metastatic or high or very high-risk prostate cancer\n  * Breast cancer at or before age 50\n  * Bilateral breast cancer\n  * Triple negative breast cancer\n  * Male breast cancer OR\n  * Healthcare provider who treats patients with any of the above types of cancer\n* Able to read and write in English or Spanish\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Patients who cannot provide informed consent\n* Patients who cannot see, read, or write\n* Patients who have the cancer and clinical characteristics defined in the inclusion criteria, but who do not speak English or Spanish\n* Patients with none of the listed cancer diagnoses and clinical characteristics\n* Healthcare provider who do not treats cancer patients",true,{"count":258,"type":21},800,[179],"This study compares the experiences of people who receive information about genetic testing from a computer-generated character to patients who receive information from a human genetics healthcare provider. Patients with cancer are increasingly recommended for genetic testing as standard of care. Multiple factors contribute to low usage of genetic testing but for many patients the lack of access to genetic counseling and testing is an important and flexible factor. Lack of access is especially relevant to racial\u002Fethnic minority patients and those living in non-metropolitan rural settings who are frequently cared for at safety-net hospitals with limited genetics services. Alternative delivery models are necessary to improve rates of access to genetic testing in patients with cancer. Health information technology is under used by genetics providers. A patient-facing relational agent (PERLA) will provide pre-test genetics education in both English and Spanish across two clinical settings to facilitate more timely access to genetic testing. Using the PERLA intervention may help researchers learn different ways to provide education about genetic testing to patients with cancer compared to usual care.",[184,262,263,264,188,265,266,108],"Male Breast Carcinoma","Malignant Solid Neoplasm","Metastatic Prostate Carcinoma","Pancreatic Exocrine Neoplasm","Stage IVB Prostate Cancer American Joint Committee on Cancer v8","2026-03-16",{"date":269,"type":133},"2026-03-18",{"date":271,"type":133},"2023-10-24",{"date":273,"type":21},"2028-10-24",{"name":275,"class":140},"University of Southern California",{"id":277,"slug":278,"hasResults":11,"nctId":279,"briefTitle":280,"officialTitle":280,"acronym":4,"eligibilityCriteria":281,"healthyVolunteers":11,"sex":175,"minAge":282,"maxAge":4,"enrollmentInfo":283,"targetDuration":4,"studyType":22,"phases":285,"briefSummary":286,"conditions":287,"keywords":4,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":300,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":306,"locationsCount":308},"100281599","multicenter-trial-for-eliminating-breast-cancer-surgery-or-radiotherapy-in-exceptional-responders-to-neoadjuvant-systemic-therapy-100281599","NCT02945579","Multicenter Trial for Eliminating Breast Cancer Surgery or Radiotherapy in Exceptional Responders to Neoadjuvant Systemic Therapy","Inclusion Criteria:\n\n* Cohort A1 and A2\n\n  • Conditions for patient eligibility: Patients on this portion of the study can receive radiation treatment at any MD Anderson Cancer Center or any outside hospital and may be enrolled prior to, during, or following neoadjuvant systemic therapy provided they meet the following eligibility and ineligibility requirements noted below:\n  1. Pathologically confirmed unicentric invasive breast cancer defined as radiologic clinical stage T1 or T2 (≤ 5 cm), N0 or N1 (≤ 4 abnormal axillary nodes on initial ultrasound), clinical stage M0.\n  2. HER2 positive (IHC 3+ and or FISH amplified) or triple receptor negative (TN, ER\u002FPR\\< 10% HER2 negative (IHC 1+ or 2+ FISH non-amplified) receiving any standard routine clinical NST regimen.\n  3. Patient desires breast conserving therapy.\n  4. Age 40 years or older. This age cutoff is justified because breast cancers in women under the age of 40 are known to have a significantly higher risk of IBTR presumably due to underlying biologic differences \\[124, 125\\].\n  5. Female sex.\n  6. If the patient has a history of a prior non-breast cancer, all treatment for this cancer must have been completed prior to study registration and the patient must have no evidence of disease for this prior non-breast cancer.\n  7. Patient must have an initial nodal ultrasound that does not demonstrate more than four suspicious lymph nodes, any suspicious lymph nodes should be biopsied to determine if nodal metastatic disease present.\n  8. Patient understands that the breast lesion size on final breast imaging must be less than or equal to 2 cm prior to the biopsy procedure being performed on study and if the biopsy shows residual carcinoma the patient will be taken off study.\n* Cohort B1 and B2\n\n  • Conditions for patient eligibility: Patients on this portion of the study will be limited to receive radiation treatment at MD Anderson Cancer Center or other approved locations and must be enrolled prior to any neoadjuvant systemic therapy provided they meet the following eligibility and ineligibility requirements noted below:\n  1. ER and\u002For PR positive, HER2 negative\n  2. Clinical stage T1N0M0, unicentric non-lobular breast cancer, no lymphovascular space invasion,\n  3. At least 40 years of age.\n  4. Oncotype ≤ 25 if age ≥ 50 years\n  5. Oncotype 0-20 and tumor size ≤ 1.5cm if age 40-49 years.\n  6. Patient agrees to take anti-estrogen therapy and is interested in breast conservation\n  7. Female sex.\n  8. If the patient has a history of a prior non-breast cancer, all treatment for this cancer must have been completed prior to study registration and the patient must have no evidence of disease for this prior non-breast cancer.\n  9. No history of prior radiation to the area of the breast that would require protocol-mandated treatment\n* Cohort C\n\n  • Conditions for patient eligibility: Patients on this portion of the study can receive surgical treatment at any MD Anderson Cancer Center or any outside hospital and may be enrolled prior to or following neoadjuvant systemic therapy provided they meet the following eligibility and ineligibility requirements noted below:\n  1. Pathologically confirmed invasive breast cancer defined as radiologic clinical stage T1 or T2 (≤ 5 cm), N0, clinical stage M0 and HER2 positive (IHC 3+ and or FISH amplified) receiving any standard routine clinical NST regimen containing her-2 directed therapy OR Pathologically confirmed invasive breast cancer defined as radiologic clinical stage T1 (≤ 2 cm), N0, clinical stage M0 and triple negative, receiving any standard routine clinical NST regimen.\n  2. For cohort C patients participating in the optional pretreatment biopsy, the patient should be able undergo biopsy or surgery of the primary tumor site of suspected or proven invasive breast cancer and should be planned to receive neoadjuvant systemic therapy.\n  3. Patient desires breast conserving therapy.\n  4. Age 30 years or older if HER2 positive. Age 50 or older if HER2 negative (triple negative).\n  5. Female sex.\n  6. If the patient has a history of a prior non-breast cancer, all treatment for this cancer must have been completed prior to study registration and the patient must have no evidence of disease for this prior non-breast cancer.\n  7. Patient must have an initial nodal ultrasound that does not demonstrate suspicious lymph nodes; any suspicious lymph nodes should be biopsied to determine if nodal metastatic disease present.\n  8. Patient must have no evidence of residual invasive tumor or DCIS on pathologic review of the lumpectomy surgical specimen\n  9. Patient must have no evidence of metastatic disease or isolated tumor cells involving the lymph nodes on pathologic review of the lymph node surgical specimen. If treatment effect in the nodes is noted on the pathology report, the investigators would generally discourage enrollment on this protocol.\n  10. Unifocal disease or limited multifocal disease that can be excised in a single lumpectomy specimen\n* Cohort D (MD Anderson Houston patients only)\n\n  * Conditions for patient eligibility: Patients on this portion of the study meet all eligibility requirements for cohort C, but have not enrolled onto the study to omit radiation. Patients in Cohort D can be identified at the time of diagnosis or prior to lumpectomy. They are not required to participate in one of the treatment arms of the study, but can ultimately choose to move to an omission Cohort at a later time point.\n\n3.5.1 Patients with triple negative or her-2 positive tumor who are amenable to breast conserving treatment and have received or are planned for neoadjuvant systemic therapy prior to surgery are eligible for Cohort D.\n\n3.5.2 Eligible patients in cohort D who have undergone optional ARTIDIS biopsies of the primary breast tumor at the time of diagnosis, prior to starting neoadjuvant therapy, or following completion of systemic therapy, at the time of surgery, may later move to Cohort A or C if they meet all eligibility requirements and ultimately desire surgery or radiation omission\n\nExclusion Criteria:\n\n1. Radiologic evidence for a stage T3 or clinical stage T4 breast cancer in Cohort A1\u002FA2\u002FC; radiologic evidence for a stage T2-T3 or clinical stage T4 breast cancer in Cohort B1\u002FB2.\n2. Clinical or pathologic evidence for distant metastases.\n3. Prior diagnosis of invasive or ductal carcinoma in situ breast cancer in the ipsilateral breast.\n4. Clinical evidence of progression of disease \\>20% in the breast or new evidence of nodal metastases.\n5. Patient is known to be pregnant.\n6. Patient is participating in a NST protocol in which surgical excision of the breast and or lymph nodes are required in Cohort A1\u002FA2\u002FB1\u002FB2.","30 Years",{"count":284,"type":21},120,[179],"This clinical trial studies eliminating surgery and\u002For radiation therapy in treating breast cancer patients. In HER2 positive and triple negative breast cancers, after systemic therapy, when image-guided biopsy shows no residual cancer, patients then receive standard breast radiotherapy with no surgery. In ER positive\u002FHER2 negative breast cancers, after endocrine therapy and ablative radiotherapy, when image-guided biopsy shows no residual cancer, patients then receive standard endocrine therapy with no surgery. For patients who have HER2 positive and triple negative breast cancers and standard surgery, after systemic therapy, breast radiotherapy is being eliminated when the pathology from surgery shows no residual cancer.",[288,289,290,291,292,293,294,295,296,297,298,108],"Estrogen Receptor Negative","HER2 Positive Breast Carcinoma","HER2\u002FNeu Negative","Invasive Breast Carcinoma","Progesterone Receptor Negative","Stage I Breast Cancer AJCC v7","Stage IA Breast Cancer AJCC v7","Stage IB Breast Cancer AJCC v7","Stage II Breast Cancer AJCC v6 and v7","Stage IIA Breast Cancer AJCC v6 and v7","Stage IIB Breast Cancer AJCC v6 and v7","2026-03-05",{"date":301,"type":133},"2026-03-09",{"date":303,"type":133},"2017-01-20",{"date":305,"type":21},"2028-01-31",{"name":307,"class":140},"M.D. Anderson Cancer Center",8,{"id":310,"slug":311,"hasResults":11,"nctId":312,"briefTitle":313,"officialTitle":314,"acronym":4,"eligibilityCriteria":315,"healthyVolunteers":11,"sex":17,"minAge":316,"maxAge":4,"enrollmentInfo":317,"targetDuration":4,"studyType":22,"phases":319,"briefSummary":320,"conditions":321,"keywords":4,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":328,"lastUpdatePostDateStruct":329,"startDateStruct":331,"completionDateStruct":333,"leadSponsor":335,"locationsCount":141},"100436149","pre-operative-sabr-with-and-without-caloric-restriction-for-early-stage-breast-cancer-100436149","NCT04959474","Pre-operative SABR With and Without Caloric Restriction for Early Stage Breast Cancer","SABR-CaRe: A Phase II Randomized Trial of Pre-Operative Stereotactic Ablative Radiation Therapy (SABR) With and Without Caloric Restriction for Early Stage Breast Cancer","Inclusion Criteria:\n\n* • Patients with pathologically proven DCIS or invasive breast cancer histologies\n* Willing and able to provide informed consent\n* Willing and able to comply with study treatments including dietary intervention\n* Body mass index (BMI) \\>= 21 at time of enrollment\n* Age \\>= 40 years at time of consent\n\n  \\* Patients with triple negative breast cancer (TNBC) must be \\>= 50 years of age at time of consent\n* Karnofsky performance status (KPS) score 70 - 100\n* Tumor size =\\\u003C 3.0 cm\n* Gross disease within the breast must be unifocal\n\n  \\* Gross disease may be multifocal as long as the total extent of tumor, gross and microscopic, occupies a volume with greatest dimension =\\\u003C 3 cm\n* Patients with invasive disease are required to have clinical axillary staging including axillary ultrasound (US) that proves patient is clinically node negative or can be done by physical examination if the patient is over 70\n* Patient is not being considered for preoperative chemotherapy\n* Must be English or Spanish speaking\n\nExclusion Criteria:\n\n* Patient is clinically node positive: clinically suspicious axillary lymph node(s) by axillary US or exam unless biopsied and found to be negative\n* Patient has stage IV metastatic disease\n\n  \\* Patients with oligo-metastatic disease who are being treated with curative intent per the treating physician will not be excluded if all other eligibility criteria are met\n* Breast tumor size is \\> 3.0 cm\n* Positive non-axillary sentinel nodes or evidence of suspicious supraclavicular, infraclavicular, or internal mammary nodes by imaging or physical exam, unless biopsied and found to be negative for tumor\n* Evidence by physical examination or mammography of other suspicious masses, densities, or microcalcifications in either breast, unless biopsied and found to be benign\n* Paget's disease of the nipple\n* Previous breast radiation on ipsilateral side\n* Any prior treatment with radiation therapy or chemotherapy for the current breast cancer diagnosis prior to registration\n* Patients with significant psychiatric illness that would preclude them from adhering to the protocol in the judgement of the treating clinician\n* BMI \\\u003C 21 at the time of study enrollment","40 Years",{"count":318,"type":21},80,[179],"This phase II trial studies the effect of calorie reduction while undergoing stereotactic ablative radiation therapy in treating patients with breast cancer. Stereotactic ablative radiation therapy (sABR) is a highly focused radiation treatment that gives an intense dose of radiation concentrated on a tumor, while limiting the dose to the surrounding organ. Giving SABR before surgery may make the tumor smaller. Adding dietary restrictions in combination with radiation therapy may help increase local control and decrease the spread of the cancer to other places in the body. The purpose of this trial is to identify if there is a decrease in tumor tissue in patients undergoing caloric restriction during pre-operative SABR, compared to patients undergoing pre-operative SABR alone.",[322,323,324,325,326,291,327],"Anatomic Stage 0 Breast Cancer AJCC v8","Anatomic Stage 1 Breast Cancer AJCC v8","Anatomic Stage 2 Breast Cancer AJCC v8","Anatomic Stage 3 Breast Cancer AJCC v8","Breast Ductal Carcinoma in Situ","Triple Negative Breast Carcinoma","2026-01-21",{"date":330,"type":133},"2026-01-23",{"date":332,"type":133},"2021-08-23",{"date":334,"type":21},"2028-11-01",{"name":336,"class":140},"Thomas Jefferson University",{"id":338,"slug":339,"hasResults":11,"nctId":340,"briefTitle":341,"officialTitle":342,"acronym":4,"eligibilityCriteria":343,"healthyVolunteers":11,"sex":175,"minAge":149,"maxAge":4,"enrollmentInfo":344,"targetDuration":4,"studyType":22,"phases":345,"briefSummary":346,"conditions":347,"keywords":4,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":348,"lastUpdatePostDateStruct":349,"startDateStruct":351,"completionDateStruct":353,"leadSponsor":355,"locationsCount":141},"100564961","phase-2-hypofractionated-radiotherapy-before-or-after-breast-surgery-for-treatment-of-patients-with-non-metastatic-breast-cancer-100564961","NCT06635980","Hypofractionated Radiotherapy Before or After Breast Surgery for Treatment of Patients With Non-Metastatic Breast Cancer","A Randomized Phase II Trial of Hypofractionated Radiotherapy for Non-Metastatic Breast Cancer Before or After Breast Surgery for Different Breast Cancer Risk Groups","Inclusion Criteria:\n\n* Age \\>= 18 years\n* Histological confirmation of breast cancer\n* Clinical stage T1-T4 N0-3 M0\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 2\n* Able to and provides Institutional Review Board (IRB)-approved study specific written informed consent\n* Able to complete all mandatory tests listed in the trial\n* Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)\n* Indications for radiotherapy for breast cancer\n\nExclusion Criteria:\n\n* Medical contraindication to receipt of radiotherapy\n* Severe active 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 and toxicity of the prescribed regimens\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements or providing informed consent in the judgment of the principal investigator\n* Active systemic lupus or scleroderma\n* Pregnancy\n* Women of childbearing potential who are unwilling to employ adequate contraception\n* Prior receipt of ipsilateral breast or chest wall radiation\n* Recurrent breast cancer",{"count":284,"type":21},[25],"This phase II trial studies how well hypofractionated radiotherapy before (preoperative) or after (postoperative) breast surgery works in treating patients with different types of non-metastatic (has not spread from original tumor site) breast cancer and to determine the outcomes and side effects of this treatment. Radiation therapy is considered an integral part of breast conserving therapy. Hypofractionated radiation therapy is a radiation treatment in which the total dose of radiation is divided into large doses and treatments are given less than once a day. This has been shown to be an effective treatment for breast cancer while reducing treatment time and decreasing side effects. Preoperative radiotherapy alone or concurrently with chemotherapy has also been tested with excellent results and with minimal toxicity. Preoperative radiation of the intact tumor with a hypofractionated regimen can potentially decrease toxicity by allowing the delivery of treatment to intact breast tissue. The potential advantages of preoperative radiation therapy include the delivery of radiation in the intact breast when radiation can be more effective as more oxygen can be available in the tissue. Furthermore, complications and cosmetic results are expected to be lower in pre-operative radiotherapy before surgery, as there have been no changes in blood supply to the breast. This lends to the possibility of using lower doses of radiotherapy to patients, and potentially better cancer associated clinical outcomes for our breast cancer patients. Undergoing hypofractionated radiation therapy before or after breast surgery may be safe and effective in treating patients with different types of non-metastatic breast cancer.",[182,183,28,184,108],"2025-12-05",{"date":350,"type":133},"2025-12-12",{"date":352,"type":133},"2025-05-14",{"date":354,"type":21},"2034-10-21",{"name":139,"class":140},{"id":357,"slug":358,"hasResults":11,"nctId":359,"briefTitle":360,"officialTitle":361,"acronym":362,"eligibilityCriteria":363,"healthyVolunteers":11,"sex":175,"minAge":316,"maxAge":364,"enrollmentInfo":365,"targetDuration":4,"studyType":22,"phases":366,"briefSummary":367,"conditions":368,"keywords":4,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":369,"lastUpdatePostDateStruct":370,"startDateStruct":372,"completionDateStruct":374,"leadSponsor":376,"locationsCount":248},"100560858","food-for-thought---a-nutrition-intervention-for-women-undergoing-active-treatment-for-triple-negative-breast-cancer-100560858","NCT06582615","Food for Thought - A Nutrition Intervention for Women Undergoing Active Treatment for Triple Negative Breast Cancer","Food for Thought - Pilot Study of a MIND Diet Intervention in Women Undergoing Active Treatment for Triple Negative Breast Cancer","MIND-TNBC","Inclusion Criteria:\n\n* Age 40-65 years\n* Female with stage I-III triple negative breast cancer\n* Less than or equal to 12 months from starting initial systemic cancer treatment (e.g. chemotherapy, targeted therapy, immunotherapy) for TNBC\n* Ability to access and use internet resources, including video calls using Zoom platform\n* English speaking\n\nExclusion Criteria:\n\n* History of dementia, stroke, traumatic brain injury, brain metastasis or other conditions that could lead to cognitive impairment\n* Current healthy eating pattern reflected by high MIND diet score (e.g. \\>12)\n* Unwilling\u002Funable to eat \\> 2 types of MIND food (e.g. avoids \\& \\> 2 categories or food groups such as leafy greens, olive oil and non-fried fish)\n* Currently pregnant\n* Unable to give informed consent","65 Years",{"count":211,"type":21},[179],"The goal of this randomized clinical trial is to learn if a healthy eating pattern called the MIND eating plan can reduce cancer-related cognitive impairment (commonly called \"chemobrain\") and other symptoms commonly experienced by women with newly diagnosed stage II-III triple negative breast cancer as they go through chemotherapy. The symptoms that will be measured include changes in memory and mental function, fatigue, sleep quality, anxiety, and depression.\n\nResearchers will compare measures from women in the 12-week MIND eating plan virtual intervention to a general health coaching (GHC) virtual intervention to see if the MIND eating plan helps reduce symptoms. Women will be contacted for follow-up measures 6 months after the 12-week interventions.\n\nWomen randomly assigned to the GHC at the beginning of the study will have the opportunity to complete the MIND intervention after the 6-month follow-up. All study sessions and measures are done remotely.\n\nParticipants will:\n\n* Be randomized to MIND or GHC interventions\n* Complete all study measures remotely (by online questionnaires, virtual visits and mail )\n* Attend 8 virtual sessions of about 15-60 minutes each over 12 weeks\n* Be sent some of the key foods in the MIND eating plan during the MIND intervention\n* Be contacted for follow-up measures 6 months after interventions",[183,28,108],"2025-12-04",{"date":371,"type":133},"2025-12-11",{"date":373,"type":133},"2024-10-28",{"date":375,"type":21},"2026-12-31",{"name":247,"class":140},{"id":378,"slug":379,"hasResults":11,"nctId":380,"briefTitle":381,"officialTitle":382,"acronym":4,"eligibilityCriteria":383,"healthyVolunteers":11,"sex":17,"minAge":149,"maxAge":4,"enrollmentInfo":384,"targetDuration":4,"studyType":22,"phases":386,"briefSummary":387,"conditions":388,"keywords":389,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":393,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":141},"100594204","phase-2-neoadjuvant-darolutamide-alone-or-in-combination-with-standard-therapy-for-stage-ii-iiia-ar-tnbc-100594204","NCT07016399","Neoadjuvant Darolutamide Alone or in Combination With Standard Therapy for Stage II-IIIA, AR+, TNBC","A Phase II Neoadjuvant Clinical Trial of the Androgen Receptor Inhibitor Darolutamide in Early-Stage Androgen Receptor Positive (AR+) Triple-Negative Breast Cancer","Inclusion Criteria:\n\n* Signed and dated written informed consent as well as the ability to understand and the willingness to sign written consent prior to study registration\n* Male or female ≥ 18 years of age on the day of signing informed consent\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Histologically confirmed newly diagnosed breast cancer with the following requirements:\n\n  * \\\u003C10% staining for estrogen receptor (ER) and progesterone receptor (PR) by immunohistochemistry (IHC)\n  * HER2 negative by fluorescence in situ hybridization (FISH)\n  * AR positive: defined as ≥ 80% staining for AR by IHC\n* Primary tumor clinically or radiographically ≥ 1cm in size or stage II-IIIA and eligible for neoadjuvant treatment\n* Absolute neutrophil count (ANC) ≥ 1500\u002FµL (≤ 28 days prior to first dose of protocol-indicated treatment)\n* Platelets ≥ 100,000\u002FµL (≤ 28 days prior to first dose of protocol-indicated treatment)\n* Hemoglobin ≥ 9.0 g\u002FdL or ≥ 5.6 mmol\u002FL (≤ 28 days prior to first dose of protocol-indicated treatment)\n* Estimated glomerular filtration rate (eGFR) ≥ 60 mL\u002Fmin (as calculated by the Cockcroft-Gault Formula or calculated\u002Fmeasured by an alternative established institutional standard consistently applied across participants at the site) (≤ 28 days prior to first dose of protocol-indicated treatment)\n* Total bilirubin ≤ 1.5 times institutional upper limit of normal (ULN), or direct bilirubin ≤ ULN for participants with total bilirubin \\> 1.5 x ULN (≤ 28 days prior to first dose of protocol-indicated treatment)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 2.5 times institutional upper limit of normal (ULN) (≤ 28 days prior to first dose of protocol-indicated treatment)\n* Calcium ≤ 11.5 mg\u002FdL or ≤ 2.9 mmol\u002FL; in patients with albumin outside the normal range, calcium (corrected for albumin) must be ≤ 11.5 mg\u002FdL or ≤ 2.9 mmol\u002FL (≤ 28 days prior to first dose of protocol-indicated treatment)\n* Women must not be breastfeeding and further agree to not breastfeed during study treatment and for at least 120 days after completion of treatment\n* A woman of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test during screening within 21 days prior to receiving first dose of protocol-indicated treatment, and must agree to follow instructions for using acceptable contraception from the time of signing consent, and until at least 120 days after completion of treatment\n* Men must refrain from donating sperm for at least 120 days after completion of treatment\n* A man able to father children who is sexually active with a WOCBP must agree to follow instructions for using acceptable contraception, from the time of signing consent, and until at least 120 days after completion of treatment\n\nExclusion Criteria:\n\n* Non-resectable breast cancer as assessed by the primary treating surgeon or evidence of metastatic disease\n* Malignancies other than TNBC within 5 years prior to randomization, with the exception of those with a negligible risk of metastases 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* Patient is pregnant or breastfeeding\n* Patients with moderate hepatic impairment (Child-Pugh Class B cirrhosis or higher)\n* Is currently participating in or within four weeks prior to receiving first dose of study treatment in a study of an investigational agent or investigational device\n\n  * Participants who have entered the follow-up phase of an investigational study may participate as long as it has been four weeks after the last dose or last exposure to the previous investigational agent or investigational device\n* Recipient of previous allogeneic tissue\u002Fsolid organ transplant\n* Known severe hypersensitivity (≥ Grade 3) to study drug, pembrolizumab, carboplatin, doxorubicin\u002Fepirubicin, paclitaxel, or cyclophosphamide and\u002For any of the excipients of these drugs\n* History of myocarditis or pericarditis or other known underlying heart disease that is clinically significant by investigator judgment (for example, cardiomyopathy, congestive heart failure with New York Heart Association \\[NYHA\\] functional classification III or IV, symptomatic arrhythmia not controlled by medication, unstable angina, history of acute myocardial infarction). History of cerebrovascular accident (including transient ischemic attack \\[TIA\\]) within the past six months (24 weeks) prior to starting study treatment\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection\u002Fsepsis, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Known conditions that would preclude the use of checkpoint inhibitors",{"count":385,"type":21},51,[25],"This phase II trial compares the effect of adding darolutamide to standard therapy versus standard therapy alone before surgery for the treatment of patients with stage II-IIIA androgen receptor positive triple-negative breast carcinoma. Standard therapy before surgery for triple-negative breast cancer typically consists of a combination of chemotherapy and immunotherapy drugs. Chemotherapy drugs, such as carboplatin, paclitaxel, doxorubicin and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. 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. Darolutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of tumor cells. Giving darolutamide in combination with standard therapy before surgery may make the tumor smaller and may reduce the amount of normal tissue that needs to be removed.",[183,29,108],[390,391],"Androgen Receptor-Positive","Luminal Androgen Receptor","2025-10-28",{"date":394,"type":133},"2025-10-30",{"date":396,"type":133},"2025-09-09",{"date":398,"type":21},"2033-10",{"name":400,"class":140},"Vandana Abramson"]