[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"breast-adenocarcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:breast-adenocarcinoma":123},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,14,0,[8,141,166,221,242,264,308,336,362,387,417,438,460,482],{"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":128,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":140},"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\n\n  * NOTE: includes fresh tissue specimen at pre-registration for complete exome and transcriptome sequencing. Patients who had tumor sequencing under certain Mayo Institutional Review Board (IRB) protocols and neoantigen has been identified or REAL Neo vaccine produced are allowed to proceed to pre-registration and\u002For registration.\n* Measurable disease as defined by RECIST (version 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\n* Willing to return to enrolling institution for follow-up\n* Willing to provide blood specimens for research\n* Negative pregnancy test =\\\u003C 7 days prior to pre-registration for persons of childbearing potential. 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 =\\\u003C 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) version 5.0 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 =\\\u003C 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 =\\\u003C 1.5 x upper limit of normal (ULN)\n  * Aspartate transaminase (AST) and alanine transaminase (ALT) =\\\u003C 3 x ULN or =\\\u003C 5 x ULN with liver metastases\n  * Creatinine =\\\u003C 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) =\\\u003C 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 (version 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 =\\\u003C 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 =\\\u003C 1.5 x ULN\n  * ALT and AST =\\\u003C 3 x ULN (=\\\u003C 5 x ULN with liver involvement)\n  * PT\u002FINR and aPTT =\\\u003C 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 =\\\u003C 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 =\\\u003C 1 year prior to pre-registration\n* Recovered from all toxicities associated with prior treatment to acceptable baseline status (for laboratory toxicity see specified limits for inclusion) or NCI CTCAE version 5.0 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\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 proceed with surgery and provide tissue specimens for complete exome and transcriptome sequencing\n\n  * NOTE: Patients who had sequencing under certain Mayo IRB protocols and neoantigens identified or REAL Neo vaccine produced are allowed to proceed to pre-registration and\u002For registration\n* Negative pregnancy test ≤7 days prior to pre-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* ECOG PS of 0 or 1\n* Anticipated life expectancy \\> 6 months\n\nPHASE II 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* The following lab values obtained =\\\u003C 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 =\\\u003C 1.5 x ULN\n  * ALT and AST =\\\u003C 3 x ULN (=\\\u003C 5 x ULN with liver involvement)\n  * PT\u002FINR and aPTT =\\\u003C 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 specimens for research\n* Willing to return to enrolling institution for follow-up\n* Negative pregnancy test =\\\u003C 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 =\\\u003C 1 year prior registration\n* Recovered from all toxicities associated with prior treatment to acceptable baseline status NCI CTCAE version 5.0 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 =\\\u003C 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 =\\\u003C 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 =\\\u003C 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 =\\\u003C 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) =\\\u003C 3 weeks prior to registration\n  * Radiation =\\\u003C 2 weeks prior to registration\n  * Major Surgery =\\\u003C 4 weeks prior to registration\n  * Received live vaccine =\\\u003C 30 days prior to registration\n  * 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 =\\\u003C 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* 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  * 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 =\\\u003C 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 =\\\u003C 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 =\\\u003C 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 =\\\u003C 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\u002Fribonucleic acid (RNA)\u002Fdeoxyribonucleic acid (DNA) 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) =\\\u003C 3 weeks prior to registration\n  * Radiation =\\\u003C 2 weeks prior to registration\n  * Major surgery =\\\u003C 4 weeks prior to registration\n  * Received live vaccine =\\\u003C 30 days prior to registration\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* Requirement for systemic corticosteroids (\\> 10 mg daily prednisone equivalent) or other immunosuppressive medications =\\\u003C 14 days prior to registration\n\n  * NOTE: Inhaled or topical steroids and adrenal replacement steroid doses \\> 10 mg daily prednisone equivalent are permitted in","ALL","16 Years",{"count":20,"type":21},132,"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],"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","RECRUITING","2026-06-18",{"date":131,"type":132},"2026-06-23","ACTUAL",{"date":134,"type":132},"2022-03-31",{"date":136,"type":21},"2028-03-31",{"name":138,"class":139},"Mayo Clinic","OTHER",1,{"id":142,"slug":143,"hasResults":11,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":4,"eligibilityCriteria":147,"healthyVolunteers":11,"sex":148,"minAge":149,"maxAge":4,"enrollmentInfo":150,"targetDuration":4,"studyType":152,"phases":4,"briefSummary":153,"conditions":154,"keywords":4,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":140},"100402252","immune-response-to-anti-her2-therapies-in-patients-with-her2-positive-stage-i-iv-breast-cancer-100402252","NCT04517838","Immune Response to Anti-HER2 Therapies in Patients With HER2-Positive Stage I-IV Breast Cancer","Immune Response to Anti-HER2 Therapies","Inclusion Criteria:\n\n* Age \\>= 18 years\n* Histological confirmed adenocarcinoma of the breast stage I-IV from the American Joint Committee on Cancer staging 8th edition\n* Any estrogen receptor (ER) or progesterone receptor (PR) but HER2 positive defined as per the most current American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guideline\n* Provide written informed consent\n* Willingness to provide blood samples for correlative research purposes\n* BLOOD AND TISSUE COHORT: Scheduled to start new anti-HER2 therapy\u002Ftherapies\n* TISSUE-ONLY COHORT: Received or previously completed anti-HER2 therapy\u002Ftherapies\n\nExclusion Criteria:\n\n* Immunocompromised patients including patients known to be human immunodeficiency virus (HIV) positive\n* Receiving systemic steroid therapy or any other immunosuppressive therapy =\\\u003C 30 days prior to registration. NOTE: Inhaled steroids, low-dose corticosteroids (e.g. equivalent to or less than oral prednisone 10 mg daily), and steroid use for primary prevention of nausea per institutional guidelines are allowed.","FEMALE","18 Years",{"count":151,"type":21},230,"OBSERVATIONAL","This study gathers information from the blood cells and tumor tissue during treatment with anti-HER2 therapies, such as trastuzumab, pertuzumab, lapatinib, or neratinib, in patients with HER2 positive stage I-IV breast cancer who are scheduled to start anti-HER2 therapy. The information gained from this study may help researchers better understand the relation between cell response and anti-HER2 therapies.",[123,155,156,157,28,32],"HER2-Positive Breast Carcinoma","Anatomic Stage I Breast Cancer AJCC v8","Anatomic Stage II Breast Cancer AJCC v8","2026-06-12",{"date":160,"type":132},"2026-06-16",{"date":162,"type":132},"2020-07-31",{"date":164,"type":21},"2028-07-27",{"name":138,"class":139},{"id":167,"slug":168,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":172,"eligibilityCriteria":173,"healthyVolunteers":11,"sex":17,"minAge":149,"maxAge":4,"enrollmentInfo":174,"targetDuration":4,"studyType":22,"phases":176,"briefSummary":177,"conditions":178,"keywords":193,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":220},"100483771","phase-1-rinatabart-sesutecan-rina-s-pro1184-gen1184-for-advanced-solid-tumors-gct1184-01-pro1184-001-100483771","NCT05579366","Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01\u002F PRO1184-001)","Phase 1\u002F2 Study of Rina-S in Patients With Locally Advanced and\u002For Metastatic Solid Tumors","RAINFOL-01","Inclusion Criteria:\n\nPart A and B:\n\n* Histologically or cytologically confirmed metastatic or unresectable solid malignancy including ovarian cancer (must have epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer), endometrial cancer, non-small cell lung cancer (Part A), EGFR-mutated NSCLC (Part B), breast cancer (hormone receptor positive, HER2-negative and triple-negative) (Part A), mesothelioma or cervical cancer (Part B).\n* Previously received therapies known to confer clinical benefit.\n* Measurable disease per RECIST v1.1 for all tumor types other than pleural mesothelioma which will use mRECIST v1.1 at baseline.\n\nPart C, E, and H:\n\nParticipants must have histologically or cytologically confirmed metastatic or unresectable epithelial ovarian cancer as specified below.\n\n* High grade serous ovarian cancer, primary peritoneal cancer, or fallopian tube cancer (excluding endometrioid, clear cell carcinomas, mucinous, low grade, and those with a sarcomatous or neuroendocrine element)\n* Participants must have received up to 3 prior lines of therapy. Participants may have had up to to 4 prior lines of therapy are allowed if MIRV is locally approved and was used as the last line of therapy. Participants must have progressed radiographically on or after their most recent line of therapy.\n* Participants must have platinum-resistant ovarian cancer.\n* Participants must have received prior bevacizumab or approved biosimilar.\n* Participants with known or suspected deleterious germline or somatic BRCA mutations (as determined by Food and Drug Administration \\[FDA\\]-approved test in a Clinical Laboratory Improvement Amendments \\[CLIA\\]-certified laboratory; or locally approved equivalent) and who achieved a complete or partial response to platinum-based chemotherapy must have been treated with a poly ADP-ribose polymerase (PARP) inhibitor as maintenance treatment.\n* Measurable disease per the RECIST v1.1 at baseline.\n\nPart D:\n\nCohort D1:\n\n* Participants must have platinum-sensitive ovarian cancer.\n* Participants must have received 1 to 3 prior lines of therapy.\n\nCohort D2:\n\n* Participants must have primary platinum-refractory, platinum-resistant, or platinum-sensitive ovarian cancer.\n* Participants with primary platinum-refractory ovarian cancer must have received ≤2 prior lines of therapy. Primary platinum-refractory ovarian cancer is defined as a lack of response or by progression within 91 days after completing front-line platinum containing therapy.\n* Participants must have received 1 to 3 prior lines of therapy for platinum-resistant ovarian cancer (PROC), and up to 4 prior lines of therapy for platinum-sensitive ovarian cancer (PSOC). Prior treatments may have included bevacizumab, PARP inhibitor, and MIRV.\n\n  * Participants with PSOC must have disease progression on or after maintenance treatment, or at least 6 months (\\>183 days) or more from the last dose of platinum-based therapy.\n\nCohort D3:\n\n• Endometrial cancer (any subtype excluding sarcoma).\n\nCohort D4:\n\n• Primary advanced or recurrent endometrial cancer (any subtype excluding sarcoma and neuroendocrine tumors).\n\nPart F and G:\n\n* Participants must have histologically or cytologically confirmed EC.\n* Recurrent progressive EC (any subtype excluding neuroendocrine tumors, carcinosarcoma, or endometrial sarcoma) following prior therapy.\n* Participants must have received 1 to 3 prior lines of therapy, and must have progressed radiographically on or after their most recent line of therapy:\n* Participants must have received prior platinum-based chemotherapy and a programmed death-ligand 1 (PD-\\[L\\])1 inhibitor.\n* Participants who progress \\>12 months after completion of prior adjuvant or neoadjuvant platinum-based chemotherapy must receive 1 additional cytotoxic systemic treatment prior to enrollment in this study.\n* Hormonal therapy alone (i.e., without chemotherapy) will not be counted as a separate line of therapy.\n* Measurable disease per the RECIST Version 1.1 at baseline.\n\nPart I:\n\n* Participants must have histologically or cytologically confirmed high grade serous or endometrioid epithelial ovarian cancer, fallopian tube cancer and primary peritoneal cancer (excluding clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies or low grade\u002Fborderline ovarian tumors).\n* Participants must have platinum sensitive ovarian cancer.\n* Measurable disease per the RECIST Version 1.1 at baseline.\n\nPart J:\n\n* Participants must have high grade epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer including serous, endometrioid, and clear cell carcinomas, and excluding mucinous, low grade, and those with a sarcomatous or neuroendocrine element.\n* Measurable disease per the RECIST Version 1.1 at baseline.\n\nPart K:\n\n* Participants must have histologically or cytologically confirmed metastatic or unresectable ovarian cancer (must have high grade epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer including serous, endometrioid, and clear cell carcinomas, and excluding mucinous, low grade, and those with a sarcomatous or neuroendocrine element).\n* Participants must have primary platinum-refractory, platinum-resistant, or platinum-sensitive ovarian cancer.\n* Measurable disease per the RECIST Version 1.1 at baseline.\n\nExclusion Criteria:\n\n* History of (non-infectious) interstitial lung disease (ILD)\u002Fpneumonitis that required steroids within the past 2 years, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.\n* Prior therapy with a topoisomerase 1 inhibitor-based antibody drug conjugate.\n\nNote: Other protocol-defined inclusion\u002Fexclusion may apply.",{"count":175,"type":21},884,[24,25],"This study will test the safety, including side effects, and determine the characteristics of a drug called Rina-S in participants with solid tumors.\n\nParticipants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable).",[179,180,181,182,183,184,185,186,123,187,188,189,190,191,192],"High Grade Epithelial Ovarian Cancer","High Grade Serous Ovarian Cancer","Primary Peritoneal Carcinoma","Fallopian Tube Cancer","Endometrial Cancer","Non-small Cell Lung Cancer","Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer (NSCLC)","Mesothelioma","Triple Negative Breast Cancer","Hormone Receptor-positive\u002FHer2 Negative Breast Cancer","Platinum-resistant Ovarian Cancer (PROC)","Platinum Sensitive Ovarian Cancer (PSOC)","Primary Refractory Ovarian Cancer","Uterine Cancer",[194,195,196,197,198,199,200,201,202,203,204,205,206,207,208,209],"antibody-drug conjugate","folate receptor alpha","folate receptor","solid tumor","ovarian cancer","primary peritoneal carcinoma","fallopian tube cancer","endometrial cancer","non-small cell lung cancer","mesothelioma","breast cancer","triple negative breast cancer","hormone receptor-positive (HR+)\u002Fhuman epidermal growth factor receptor 2 negative (HER2-) breast cancer","topoisomerase I inhibitor","PROC","epidermal growth factor receptor (EGFR)-mutated NSCLC","2026-06-01",{"date":212,"type":132},"2026-06-03",{"date":214,"type":132},"2022-12-07",{"date":216,"type":21},"2027-10",{"name":218,"class":219},"Genmab","INDUSTRY",66,{"id":222,"slug":223,"hasResults":11,"nctId":224,"briefTitle":225,"officialTitle":225,"acronym":4,"eligibilityCriteria":226,"healthyVolunteers":11,"sex":148,"minAge":149,"maxAge":4,"enrollmentInfo":227,"targetDuration":4,"studyType":152,"phases":4,"briefSummary":229,"conditions":230,"keywords":4,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":241,"locationsCount":140},"100546970","enhancing-skin-appearance-and-quality-of-life-in-breast-cancer-survivors-on-aromatase-inhibitor-therapy-100546970","NCT06401889","Enhancing Skin Appearance and Quality of Life in Breast Cancer Survivors on Aromatase Inhibitor Therapy","Inclusion Criteria:\n\n* \\* Female ≥ 18 years\n\n  * Postmenopausal women suitable to receive aromatase inhibitor as per physician's discretion\n  * Histologically confirmed adenocarcinoma of the breast stage 0-III with estrogen receptor (ER) and\u002For progesterone receptor (PR) positive per American Society of Clinical Oncology (ASCO)\u002F College of American Pathologists (CAP) guideline and any human epidermal growth factor receptor 2 (HER2)\n  * Patients must not have received any prior chemotherapy or endocrine therapy for their current breast cancer. Patients who received tamoxifen or raloxifene or another agent for prevention of breast cancer may be included\n  * Patients willing to avoid any facial procedures including facials, neurotoxin injections, fillers, or lasers during study period\n  * Willing and able to provide consent\n\nExclusion Criteria:\n\n* \\* Patients who have previously taken AIs\n\n  * Patients using prescription tretinoin, neurotoxin injections, fillers, facial lasers, microneedling, or facials within 6 months of study consent",{"count":228,"type":21},35,"This study evaluates changes in skin quality and self-esteem among breast cancer patients who are initiating aromatase inhibitor therapy.",[231,156,157,28,123,232,233],"Anatomic Stage 0 Breast Cancer AJCC v8","Estrogen Receptor-Positive Breast Carcinoma","Progesterone Receptor-Positive Breast Carcinoma","2026-05-18",{"date":236,"type":132},"2026-05-19",{"date":238,"type":132},"2024-07-19",{"date":240,"type":21},"2027-07-19",{"name":138,"class":139},{"id":243,"slug":244,"hasResults":11,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":4,"eligibilityCriteria":248,"healthyVolunteers":11,"sex":148,"minAge":149,"maxAge":4,"enrollmentInfo":249,"targetDuration":4,"studyType":22,"phases":251,"briefSummary":252,"conditions":253,"keywords":4,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":140},"100557459","phase-2-high-cannabidiol-plant-extract-brc-001-to-improve-aromatase-inhibitor-induced-arthralgia-in-women-with-breast-cancer-100557459","NCT06538389","High Cannabidiol Plant Extract (BRC-001) to Improve Aromatase Inhibitor-Induced Arthralgia in Women With Breast Cancer","High Cannabidiol (CBD) Standardized Extract for Aromatase Inhibitor-Induced Arthralgia - A Randomized Controlled Double Blind Clinical Trial","Inclusion Criteria:\n\n* Documented informed consent of the participant\n* Age: ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) ≤ 2\n* Postmenopausal by last menses \\> 12 months or medically induced menopause in premenopausal women for AI therapy use\n* At least 5 years since other malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or adequately treated stage I or II cancer from which the patient is currently in complete remission\n* Ability to read and understand English, Spanish, or translations by interpreters for questionnaires\n* Histologically confirmed primary invasive adenocarcinoma of the breast or ductal carcinoma in situ of the breast\n\n  * Stage 0, I, II, or IIIA disease\n  * No metastatic disease\n* Must have undergone definitive breast cancer surgery and recovered\n* Must have completed adjuvant chemotherapy as applicable, including systemic chemotherapy, anti-HER2 therapy, and\u002For radiation therapy\n* Estrogen-receptor positive (ER+) and\u002For progesterone-receptor positive (PR+)\n* Currently taking a third-generation aromatase inhibitor (AI) (e.g., anastrozole \\[Arimidex (registered trademark)\\], letrozole \\[Femara (registered trademark)\\], or exemestane \\[Aromasin (registered trademark)\\]) for ≥ 90 days prior to registration with plans to continue for ≥ 180 days after registration\n* Must have a worst pain\u002Fstiffness of ≥ 4 on the Brief Pain Inventory (BPI) (item #2) that has started or increased with AI therapy\n\nExclusion Criteria:\n\n* \\\u003C 3 months since prior cannabinoid containing cannabis or hemp products including CBD, tetrahydrocannabinol (THC), Marinol, and Epidiolex and must agree to refrain from use from sources outside of this study\n* \\\u003C 28 days since prior investigational agents\n* Medical therapy, alternative therapy, or physical therapy for joint pain\u002Fstiffness within the past 30 days\n* Narcotic use within 14 days of registration\n* Patients may have received corticosteroid treatment; however, the following criteria apply:\n\n  * Patients must not have received oral or intramuscular corticosteroids within 28 days prior to registration\n  * Patients must not have received intra-articular steroids to the study, or any other, joint within 28 days prior to registration\n* Patients must not have received topical analgesics (e.g., capsaicin preparations) to the study joint or any other analgesics (e.g., opiates, tramadol; with exception of nonsteroidal anti-inflammatory drugs \\[NSAIDs\\] and acetaminophen) within 14 days prior to registration\n* History of bone fracture or surgery of the afflicted hands, knees, and\u002For other joints within 6 months prior to registration\n* Any uncontrolled illness including ongoing or active infection\n* Known allergies or contraindications to cannabis\n* Significantly impaired hepatic function (alanine aminotransferase \\[ALT\\] \\> 5 x upper limit of normal \\[ULN\\] or total bilirubin \\[TBL\\] \\> 2 x ULN) OR the ALT or aspartate aminotransferase (AST) \\> 3 x ULN and TBL \\> 2 x ULN (or international normalized ratio \\[INR\\] \\> 1.5\n* Grade 3+ renal impairment\n* Clinically significant lab abnormalities in ALT, AST, total bilirubin, hemoglobin, hematocrit, or creatinine or any other laboratory tests that in the opinion of the investigator would prevent the patient from safely participating in the study\n* Having current thoughts of suicide or self-harm or history of suicidal ideation or attempted suicide\n* Meeting Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V) criteria for current major psychiatric illness, such as bipolar disorder, major depression, or psychosis (including schizophrenia and affective psychosis)\n* History of seizure disorder\n* Concomitant administration with drugs that may interact adversely with CBD including warfarin, theophylline, amiodarone, anti-epileptic (e.g., clobazam, stiripentol, valproate, topiramate), anticonvulsant (e.g., diazepam, lamotrigine, phenytoin, ethosuximide, oxcarbazepine, pregabalin, tigabine, gabapentin); 3) barbiturate (e.g., phenobarbital, hexobarbital), benzodiazepine (e.g, chlordiazepoxide, clonazepam), opioid\u002Fnarcotic (e.g, codeine, morphine)\n* Concomitant administration of cyclin-dependent kinase 4\u002F6 inhibitors, such as abemaciclib, with AI therapy\n* Following a physical examination, the patient has any abnormalities that, in the opinion of the investigator would prevent the patient from safely participating in the study\n* Other active malignancy\n* Any other condition or medication use that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Participants unwilling to abstain from donation of blood during the study\n* Participants who plan to travel outside of the United States during the study period\n* Women with childbearing potential are not eligible to participate. The study is for postmenopausal women taking aromatase inhibitors for adjuvant endocrine therapy\n* Participants with cognitive impairment are excluded due to dose titration instructions and completion of questionnaires\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)",{"count":250,"type":21},36,[25],"This phase II trial tests the effectiveness of cannabidiol (CBD) plant extract (BRC-001) in improving joint stiffness and pain (arthralgia) in women with breast cancer taking aromatase inhibitors (AIs). AIs lower blood levels of estrogen in postmenopausal women to reduce breast cancer recurrence. Women on AI therapy may experience joint stiffness, pain and arthritis symptoms as a side effect of the medication. Some women stop AI therapy due to these side effects and do not receive the maximum benefit from the medication. CBD is derived from the same plant family as marijuana but is not associated with a \"high\" or mind-altering effect and is not habit-forming. Research in animals and humans indicates that CBD might decrease inflammation in joint tissues and may help reduce chronic pain in ailments such as arthritis. BRC-001 may reduce joint pain in women with breast cancer taking AIs.",[231,156,157,29,123,254,232,233],"Breast Ductal Carcinoma In Situ","2026-04-27",{"date":257,"type":132},"2026-04-30",{"date":259,"type":132},"2024-08-26",{"date":261,"type":21},"2027-01-24",{"name":263,"class":139},"City of Hope Medical Center",{"id":265,"slug":266,"hasResults":11,"nctId":267,"briefTitle":268,"officialTitle":269,"acronym":270,"eligibilityCriteria":271,"healthyVolunteers":11,"sex":148,"minAge":149,"maxAge":4,"enrollmentInfo":272,"targetDuration":4,"studyType":22,"phases":274,"briefSummary":276,"conditions":277,"keywords":282,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":307},"100572929","preoperative-radiation-therapy-and-immediate-breast-reconstruction-100572929","NCT06739655","Preoperative Radiation Therapy and Immediate Breast Reconstruction","Preoperative Radiation Therapy and Immediate Breast Reconstruction, a Phase 3 Randomized Controlled Trial in the Belgian Population","PRADAIIBE","Screening assessments, including review of all study eligibility criteria must be completed before enrolment and randomisation.\n\nInclusion criteria:\n\nIn order to be eligible to participate in this study, a participant must meet all of the following criteria:\n\n1\\. Women ≥18 years with histopathologically confirmed breast cancer who:\n\n1.a. require SSM\u002FNSM for any reason (e.g. extensive disease)\n\n1.b. require postoperative radiation therapy of at least the chest wall\n\n1. c. have a wish for a breast reconstruction\n2. An Eastern Cooperative Oncology Group (ECOG) performance status grade ≤ 2\n3. Participant is able and willing to provide written informed consent, which includes compliance with and ability to undergo all study procedures, and attend the scheduled follow-up visit(s) per protocol.\n\nExclusion criteria:\n\nA potential participant who meets any of the following criteria will be excluded from participation in this study:\n\n1. A previous history of breast cancer or irradiation of the chest wall for any other indication, on the other side (ipsilateral). A bilateral SSM\u002FNSM + reconstruction (e.g. in case of a contralateral prophylactic SSM\u002FNSM), or previous contralateral breast cancer disease\u002Ftreatment, do not fall under this criterium and are thus allowed.\n2. Collagen synthesis disease\n3. Ongoing pregnancy\n4. Actively breastfeeding\n5. Smoking at time of inclusion (a history of smoking is allowed but needs to be registered in the eCRF). No interval between smoking cessation and study inclusion is defined, but the reconstructive surgeon needs to be willing to operate the patient using autologous tissue transfer. This generally translates to a smoking cessation of \\>3months preoperatively.\n6. BMI \\> 35 kg\u002Fm2\n7. cT4d tumour, metastatic disease or any reason making SSM\u002FNSM not indicated",{"count":273,"type":21},180,[275],"NA","The goal of this phase III randomized controlled trial (PRADAIIBE) is to assess if preoperative radiation therapy (Preop-RT) combined with immediate breast reconstruction (IBR) can safely improve both aesthetic and quality of life outcomes in breast cancer patients, compared to the standard of care (SoC) therapy consisting of post-mastectomy radiation therapy (PMRT) and delayed\u002Fimmediate breast reconstruction, in a population of breast cancer patients with an indication of mastectomy and PMRT.\n\nThe following hypotheses and outcomes will be assessed at the primary endpoint of 1 year of follow-up:\n\n* Efficacy: Does Preop-RT+IBR lead to a higher BREAST-Q satisfaction with breasts score (primary endpoint), EQ-5D-5L VAS score , EQ-5D-5L Index score, AIS-Total Aesthetic Score, or a shorter treatment duration compared to SoC?\n* Safety: Does Preop-RT+IBR lead to an increase in adverse events (general or surgical), a lower rate of pathologic Complete Response (pCR), or worse survival outcomes compared to SoC? \\[Note: this study was not powered as a non-inferiority trial, all outcomes will be pooled internationally with parallel studies\\]\n\nEligible and consenting participants will undergo screening and baseline assessments. They will then be randomised between experimental (Preop-RT+IBR) and control (SoC) groups, in a 1:1 stratified variable block size design. Follow-up will take place at 3 months, 1, 2, 5, and 10 years after the last study treatment. At baseline and during each follow-up visit each participant will complete the Breast Q 'satisfaction with breasts' and EQ-5D-5L scales, photographs will be taken. During follow-up pCR will be assessed if applicable, adverse events will be registered, and oncological follow-up will be recorded.",[278,279,123,280,281],"Breast Neoplasms","Breast Carcinoma","Cancer","Neoplasm",[283,284,285,286,287,288,289,290,291,292,293,294,295,296,297],"Breast cancer","Radiotherapy","PRADA","Breast reconstruction","BreastQ","QoL","Skin Sparing Mastectomy","Mastectomy","Breast surgery","radiation therapy","Preoperative radiation therapy","Preoperative RT","Cosmesis","Breast satisfaction","Immediate Breast Reconstruction","2026-02-02",{"date":300,"type":132},"2026-02-04",{"date":302,"type":132},"2025-02-20",{"date":304,"type":21},"2038-02-20",{"name":306,"class":139},"Cancer Research Antwerp",6,{"id":309,"slug":310,"hasResults":11,"nctId":311,"briefTitle":312,"officialTitle":312,"acronym":313,"eligibilityCriteria":314,"healthyVolunteers":11,"sex":17,"minAge":149,"maxAge":4,"enrollmentInfo":315,"targetDuration":317,"studyType":152,"phases":4,"briefSummary":318,"conditions":319,"keywords":321,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":326,"lastUpdatePostDateStruct":327,"startDateStruct":329,"completionDateStruct":331,"leadSponsor":333,"locationsCount":335},"100622883","a-prospective-multicenter-registry-to-observe-the-treatment-patterns-clinical-outcomes-and-decision-making-in-patients-with-early-breast-cancer-eligible-for-endopredict-testing-100622883","NCT07389408","A Prospective, Multicenter Registry to Observe the Treatment Patterns, Clinical Outcomes, and Decision-Making in Patients With Early Breast Cancer Eligible for EndoPredict® Testing","PRELUDE","Inclusion Criteria:\n\n* Age ≥ 18 years old.\n* Histological diagnosis of invasive breast cancer.\n* T1-T3 tumor size.\n* 0-3 positive axillary lymph nodes.\n* Documented ER-positive tumor by immunohistochemistry (≥1% or Allred Score: ≥3\u002F8 or H-score: ≥50\u002F 300)\n* Documented HER2-negative tumor by immunohistochemistry and\u002For in situ hybridization\n* Subject with signed and dated informed consent form.\n\nExclusion Criteria:\n\n* History of another primary malignancy within the last 5 years, except for resected non-melanoma skin cancer.\n* Pre-operative chemotherapy administered.\n* Subject without signed and dated informed consent form.",{"count":316,"type":21},2000,"10 Years","The study is planned to observe and document the therapeutic decision-making process, treatment protocols, and clinical outcomes in patients with luminal breast cancer, whether they have undergone EndoPredict® testing or not",[320,123],"Breast Cancer",[204,322,323,324,325],"luminal subtype","EndoPredict","genetic signature","survival","2026-01-31",{"date":328,"type":132},"2026-02-05",{"date":330,"type":132},"2025-04-01",{"date":332,"type":21},"2038-12-31",{"name":334,"class":139},"National and Kapodistrian University of Athens",13,{"id":337,"slug":338,"hasResults":11,"nctId":339,"briefTitle":340,"officialTitle":340,"acronym":341,"eligibilityCriteria":342,"healthyVolunteers":343,"sex":148,"minAge":149,"maxAge":4,"enrollmentInfo":344,"targetDuration":4,"studyType":22,"phases":346,"briefSummary":347,"conditions":348,"keywords":349,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":354,"startDateStruct":356,"completionDateStruct":358,"leadSponsor":360,"locationsCount":140},"100598307","effects-of-chemotherapy-treatment-on-metaboreflex-mechanoreflex-and-baroreflex-function-protect-08b-study-100598307","NCT07069790","Effects of Chemotherapy Treatment on Metaboreflex, Mechanoreflex, and Baroreflex Function: PROTECT-08B Study","PROTECT-08B","Inclusion Criteria:\n\nPatient group :\n\n* Stage I to III breast cancer\n* Having completed (neo)adjuvant chemotherapy treatment less than three weeks ago\n\nControl group :\n\n\\- healthy women (no history of cancer) of similar age, weight, and physical activity level\n\nExclusion Criteria:\n\n* History of cancer\n* Any known chronic pathology\n* Protected minor or adult\n* Psychiatric, musculoskeletal or neurological problems\n* Implantation of a pacemaker\n* Pregnant woman\n* Presenting at least one contraindication to the use of transient blood flow occlusion",true,{"count":345,"type":21},24,[275],"Breast cancer is the most common cancer worldwide, with over 2.2 million new cases diagnosed in 2020. Treatments such as chemotherapy often lead to a reduced exercise capacity, mainly due to cardiovascular and neuromuscular dysfunctions. This decline appears to be primarily caused by increased central fatigue, while peripheral fatigue remains unchanged. This imbalance suggests a hyperactivation of type III-IV afferent nerve fibers, which are involved in the metaboreflex-a mechanism that significantly influences cardiovascular responses during exercise. Two non-invasive methods, post-exercise circulatory occlusion (PECO) and passive leg movement (PLM), will be used to assess this hyperactivity in patients. Additionally, baroreflex function-crucial for regulating blood pressure-will be evaluated using a direct method to determine its sensitivity and reactivity. By comparing patients with healthy controls under submaximal stimuli, this study aims to better understand chemotherapy-induced cardiovascular dysfunctions. Ultimately, the goal is to design personalized exercise programs to restore cardiovascular function and reduce treatment-related side effects.",[123],[204,350,351,352],"fatigue","muscle","heart","2025-12-30",{"date":355,"type":132},"2025-12-31",{"date":357,"type":132},"2025-10-02",{"date":359,"type":21},"2026-10-02",{"name":361,"class":139},"Centre Paul Strauss",{"id":363,"slug":364,"hasResults":11,"nctId":365,"briefTitle":366,"officialTitle":367,"acronym":4,"eligibilityCriteria":368,"healthyVolunteers":11,"sex":148,"minAge":149,"maxAge":369,"enrollmentInfo":370,"targetDuration":4,"studyType":22,"phases":372,"briefSummary":373,"conditions":374,"keywords":375,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":380,"startDateStruct":381,"completionDateStruct":383,"leadSponsor":385,"locationsCount":140},"100561888","phase-1-assessing-combined-sbrt-in-breast-cancer-non-responders-to-neoadjuvant-chemotherapy-100561888","NCT06596018","Assessing Combined SBRT in Breast Cancer Non-Responders to Neoadjuvant Chemotherapy","Efficacy and Safety Evaluation of Combined Preoperative Radiotherapy in Breast Cancer Patients With No Response to Initial Neoadjuvant Chemotherapy","Inclusion Criteria:\n\n* Confirmed histologic diagnosis of invasive adenocarcinoma of the breast;\n* Stage T1-4N+M0 breast cancer (i.e., stages II and III);\n* Breast MRI showing no extracapsular extension of lymph node involvement;\n* The standard neoadjuvant chemotherapy regimen has been deemed ineffective after two cycles, with disease assessed as stable (SD) or progressive (PD) according to RECIST 1.1 criteria;\n* ECOG performance status score of 0-2;\n* Screening laboratory values must meet the following criteria:\n\n  i. White blood cells (WBCs) ≥ 2000\u002FμL ii. Absolute neutrophil count (ANC) ≥ 1500\u002FμL iii. Platelets ≥ 100 x 103\u002FμL iv. Hemoglobin ≥ 11.0 g\u002FdL v. Serum creatinine ≤ 2 mg\u002FdL (or glomerular filtration rate ≥ 40 ml\u002Fmin) vi. AST ≤ 2.5 x upper limit of normal (ULN) vii. ALT ≤ 2.5 x ULN viii. Total bilirubin within normal limits (except subjects with Gilbert\\'s syndrome, who must have total bilirubin \\< 3.0 mg\u002FdL) ix. INR ≤ 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulant(s) x. Negative HIV screening test xi. Negative screening tests for Hepatitis B and Hepatitis C. Patients with positive results that do not indicate true active or chronic infection may enroll after discussion and consensus agreement by the treating physician and principal investigator.\n\nExclusion Criteria:\n\n* Evidence of metastatic disease;\n* Known additional malignancy that is progressing or has required active treatment within the past 3 years；\n* Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug；\n* Patients with other concurrent severe and\u002For uncontrolled medical conditions which could compromise participation in the study；\n* Pregnancy or breastfeeding.","75 Years",{"count":371,"type":21},96,[24,25],"The goal of this clinical trial is to assess whether the addition of preoperative stereotactic body radiation therapy (SBRT) can improve pathological complete response (pCR) rates and safety in breast cancer patients who do not respond to initial neoadjuvant chemotherapy. The main questions it aims to answer are:\n\n* Can the combination of SBRT with chemotherapy increase pCR rates in non-responders to initial neoadjuvant chemotherapy?\n* Does the addition of SBRT to chemotherapy have acceptable safety and tolerability profiles?\n\nParticipants in this trial will be early or locally advanced breast cancer patients who have shown no response to two cycles of standard neoadjuvant chemotherapy. They will be randomly assigned to either continue with the standard chemotherapy (control group) or receive SBRT in addition to continuing the standard chemotherapy (intervention group). The primary outcome measures will be pCR rate and breast conservation rate. Secondary outcomes will include 3-year local progression-free survival, overall survival, surgical complications, and treatment toxicities.",[123],[204,376,377,378],"chemo-resistance","neoadjuvant radiation","pCR rate","2025-12-28",{"date":353,"type":132},{"date":382,"type":132},"2024-12-25",{"date":384,"type":21},"2028-09-20",{"name":386,"class":139},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":388,"slug":389,"hasResults":11,"nctId":390,"briefTitle":391,"officialTitle":392,"acronym":393,"eligibilityCriteria":394,"healthyVolunteers":11,"sex":148,"minAge":149,"maxAge":4,"enrollmentInfo":395,"targetDuration":4,"studyType":22,"phases":397,"briefSummary":398,"conditions":399,"keywords":400,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":409,"startDateStruct":411,"completionDateStruct":413,"leadSponsor":415,"locationsCount":140},"100602377","definitive-radiation-therapy-for-inoperable-breast-cancer-100602377","NCT07122713","Definitive Radiation Therapy for Inoperable Breast Cancer","Multi-institutional Prospective Pilot Study of Definitive Breast Radiation Therapy for Invasive Breast Cancer Patients Not Undergoing Definitive Surgery","DEFINE","Inclusion Criteria:\n\n* Biopsy proven invasive carcinoma of the breast, either lobular, ductal and\u002For no special type\n* T1-T4, N0-2, M0-1 invasive breast carcinoma by radiological or clinical criteria\n* Cancer is deemed unresectable, or the patient is a poor surgical candidate as determined following evaluation by a surgeon, or patient declines surgery.\n* Life expectancy \\> 6 months\n* Negative pregnancy test at the time of start of treatment in any female of reproductive age\n\nExclusion Criteria:\n\n* Concurrent systemic therapy (except for endocrine therapy, HER2-targeted therapy, or immunotherapy which are permitted)\n* Prior radiation to ipsilateral breast or regional nodes\n* Inability to receive study treatment planning and treatment secondary to body habitus",{"count":396,"type":21},30,[275],"The purpose of this study is to find out if adding radiation therapy to routine medications for breast cancer helps in reducing and preventing the cancer from getting worse. Patients with a locally advanced breast cancer who cannot, or do not want to, undergo surgery are eligible to participate. Participation in this study does not prevent you from undergoing surgery in the future.",[320,123],[401,292,402,403,404,405,406,407],"inoperable breast cancer","breast radiation","novel treatment","new treatment breast","cyberknife","non-invasive","stereotactic radiation","2025-12-15",{"date":410,"type":132},"2025-12-17",{"date":412,"type":132},"2025-12-08",{"date":414,"type":21},"2033-12-30",{"name":416,"class":139},"Alexander Stessin",{"id":418,"slug":419,"hasResults":11,"nctId":420,"briefTitle":421,"officialTitle":422,"acronym":423,"eligibilityCriteria":424,"healthyVolunteers":11,"sex":17,"minAge":149,"maxAge":4,"enrollmentInfo":425,"targetDuration":4,"studyType":152,"phases":4,"briefSummary":426,"conditions":427,"keywords":4,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":429,"lastUpdatePostDateStruct":430,"startDateStruct":432,"completionDateStruct":434,"leadSponsor":436,"locationsCount":140},"100596594","personalization-of-external-beam-radiation-therapy-in-localised-tumours-100596594","NCT07047495","Personalization of External Beam Radiation Therapy in Localised Tumours","MINIONS - Patient-specific Microstructural and radIobiological Model for persoNalised External Beam radiatION Therapy in Localised tumourS","MINIONS","Inclusion criteria for prostate patients:\n\n* Unifocal infiltrating ductal breast carcinoma, non-special histotype\n* clinical stage T1-T2,N0\n* No contraindications to MRI, or metal joint prostheses from knee to shoulder included, or femoral stent.\n* Patients aged \\>18 years\n* Good general condition (ECOG 0-2)\n* Expected active treatment (crioablation or surgery or radiotherapy ).\n\nExclusion Criteria:\n\n* Exclusion criteria for prostate patients:\n\n  * Nodule involvement and metastasis (cN1 and\u002For cM1)\n  * Concomitant inflammation of the intestine\n  * Significant systemic diseases or ongoing oral anticoagulant therapy\n  * Non-compliance of dose constraints in the treatment plan\n  * Previous invasive cancer, unless the patient has had no disease for at least 3 years\n  * Mental disorders that cannot ensure valid informed consent\n\nExclusion criteria for breast patients:\n\n* Histology other than non-special histotype and non-epithelial tumors (sarcoma, lymphoma)\n* Male sex\n* High-risk mutation carrier patients\n* Bilateral breast cancer\n* synchronous distant metastases\n* Neoadjuvant therapy\n* autoimmune connective tissue diseases\n* previous radiotherapy to the chest\n* Mental disorders that cannot ensure valid informed consent\n* No previous thoracic radiotherapy",{"count":228,"type":21},"The study will include the prospective acquisition of optimized MR imaging data of prostate and breast patients treated with radiotherapy (RT).\n\nWithin the prospective study, biological specimens from patients undergoing in-room biopsy before RT, will be collected. Histological evaluation and cell culture (and organoid preparation) will be conducted, and samples\u002Forganoids will be irradiated with RT for biological validation.",[123,428],"Prostate Cancer (Adenocarcinoma)","2025-06-24",{"date":431,"type":132},"2025-07-02",{"date":433,"type":21},"2025-07",{"date":435,"type":21},"2030-07",{"name":437,"class":139},"European Institute of Oncology",{"id":439,"slug":440,"hasResults":11,"nctId":441,"briefTitle":442,"officialTitle":442,"acronym":4,"eligibilityCriteria":443,"healthyVolunteers":11,"sex":148,"minAge":149,"maxAge":444,"enrollmentInfo":445,"targetDuration":4,"studyType":22,"phases":447,"briefSummary":448,"conditions":449,"keywords":4,"overallStatus":450,"whyStopped":4,"lastUpdateSubmitDate":451,"lastUpdatePostDateStruct":452,"startDateStruct":454,"completionDateStruct":456,"leadSponsor":458,"locationsCount":4},"100591206","the-application-value-of-spectral-ct-in-the-accurate-staging-of-breast-cancer-100591206","NCT06977412","The Application Value of Spectral CT in the Accurate Staging of Breast Cancer","Inclusion Criteria:\n\n* (a) Chest quark energy spectrum CT examination was performed within 1 week before treatment\n* (b) Age ≥ 18\n* (c) Suspected breast cancer patients\n* (d) Patients who signed informed consent\n\nExclusion Criteria:\n\n* (a) Severe cardiac, pulmonary and renal insufficiency\n* (b) Allergic to iodine contrast media\n* (c) Unable to cooperate to complete CT examination\n* (d) Quark spectrum CT image is poor and cannot be used\n* (e) Male, pregnant and lactating female\n* (f) Combined with other tumor history\n* (g) Incomplete clinical and pathological data\n* (h) Pathologically confirmed non breast cancer","80 Years",{"count":446,"type":21},150,[275],"Spectral CT was used to prospectively collect medical images and clinical data related to breast cancer, evaluate the effect of image quality in the diagnosis of breast cancer, and evaluate the application value in the accurate staging of breast cancer, so as to provide a more accurate clinical basis for diagnosis, promote the development of individualized treatment, and ultimately improve the prognosis of patients.",[123],"NOT_YET_RECRUITING","2025-05-16",{"date":453,"type":132},"2025-05-18",{"date":455,"type":21},"2025-06-01",{"date":457,"type":21},"2026-05-31",{"name":459,"class":139},"Yunnan Cancer Hospital",{"id":461,"slug":462,"hasResults":11,"nctId":463,"briefTitle":464,"officialTitle":465,"acronym":466,"eligibilityCriteria":467,"healthyVolunteers":11,"sex":148,"minAge":149,"maxAge":468,"enrollmentInfo":469,"targetDuration":4,"studyType":22,"phases":471,"briefSummary":472,"conditions":473,"keywords":4,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":474,"lastUpdatePostDateStruct":475,"startDateStruct":477,"completionDateStruct":479,"leadSponsor":481,"locationsCount":140},"100567674","phase-2-neoadjuvant-toripalimab-and-radiotherapy-treatment-in-n-hr-breast-cancer-100567674","NCT06671262","Neoadjuvant Toripalimab and Radiotherapy Treatment in N+ HR+ Breast Cancer","Neoadjuvant Toripalimab and Radiotherapy Treatment in Lymph Nodes Positive HR Positve Breast Cancer（NEOTRIO-HR）","NEOTRIO-HR","Inclusion Criteria:\n\n* High-risk HR+\u002FHER2-negative breast cancer is defined as ER≥1%, HER2-negative (\\\u003C2+ Her2 IHC or \\\u003C2.2 HER2\u002FCEP17 ratio by FISH) and either histologic grade II-III or a high-risk genomic assay score (Oncotype RS\\>25, high risk Mammaprint, PAM-50, EndoPredict or ProSigna score). primary tumor size ≥1.0 cm in maximum diameter and axillary node-positive breast cancer;\n* Stage T1-4N+M0 (i.e., Stage II, III), with confirmed N+ by biopsy, and no signs of distant metastasis;\n* The initial PD-L1 expression level conducted on the tumor tissue sample with Combined Positive Score (CPS) or Tumor Proportion Score (TPS)\\\u003C 10%;\n* ECOG score of 0-1;\n* Screening laboratory values must meet the following criteria: i. White blood cells (WBCs) ≥ 2000\u002FμL ii. Absolute neutrophil count (ANC) ≥ 1500\u002FμL iii. Platelets ≥ 100 x 103\u002FμL iv. Hemoglobin ≥ 11.0 g\u002FdL v. Serum creatinine ≤ 2 mg\u002FdL (or glomerular filtration rate ≥ 40 ml\u002Fmin) vi. AST ≤ 2.5 x upper limit of normal (ULN) vii. ALT ≤ 2.5 x ULN viii. Total bilirubin within normal limits (except subjects with Gilbert's syndrome, who must have total bilirubin \\\u003C 3.0 mg\u002FdL) ix. INR ≤ 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulant(s) x. Negative HIV screening test xi. Negative screening tests for Hepatitis B and Hepatitis C. Patients with positive results that do not indicate true active or chronic infection may enroll after discussion and consensus agreement by the treating physician and principal investigator.\n\nExclusion Criteria:\n\n* Inflammatory breast cancer\n* Life-threatening organ dysfunction or complications, active infectious diseases, active hepatitis B, hepatitis C virus infection, autoimmune diseases within two years, undergoing immunosuppressive drug treatment or chronic systemic corticosteroid therapy (dose exceeding 10mg per day of prednisone or equivalent);\n* Clinically symptomatic heart disease;\n* Previous systemic treatment or radiotherapy for breast cancer;\n* Patients with cosmetic breast implants, i.e., having implants under the skin at the time of diagnosis;\n* Radiotherapy contraindications: history of radiotherapy;\n* Women shall not be breastfeeding.","85 Years",{"count":470,"type":21},74,[25],"The goal of this clinical trial is to compare the efficacy and safety in patients with lymph node-positive HR+\u002FHER2- breast cancer. The main questions it aims to answer are:\n\n* Can the incorporation of intensified radiation to the tumor (tumor boost) enhance the pCR rate on the basis of neoadjuvant immuno-chemotherapy？\n* Can it improve the level of residual cancer burden (RCB) and change the tumor immune microenvironment? and How safe will be the combined therapy?\n\nParticipants will be randomly assigned to one of three treatment regimens:\n\n1. Preoperative toripalimab combined with SBRT targeting both the primary tumor and axillary lymph nodes, followed by chemotherapy;\n2. Preoperative toripalimab combined with SBRT focused solely on the primary tumor, followed by chemotherapy;\n3. Preoperative toripalimab combined with chemotherapy alone.\n\nFollowing the completion of their respective treatment regimens, participants will proceed to undergo surgery. The effectiveness of the treatments will be assessed through pathological evaluations, as well as by measuring levels of residual cancer burden (RCB) and examining changes in the tumor immune microenvironment.\n\nThe study aims to evaluate the safety of these combined treatment approaches and to determine if they offer superior efficacy compared to outcomes reported in previous studies.",[123],"2025-02-09",{"date":476,"type":132},"2025-02-11",{"date":478,"type":132},"2024-12-26",{"date":480,"type":21},"2027-11-01",{"name":386,"class":139},{"id":483,"slug":484,"hasResults":11,"nctId":485,"briefTitle":486,"officialTitle":487,"acronym":488,"eligibilityCriteria":489,"healthyVolunteers":11,"sex":17,"minAge":149,"maxAge":4,"enrollmentInfo":490,"targetDuration":4,"studyType":152,"phases":4,"briefSummary":492,"conditions":493,"keywords":531,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":537,"lastUpdatePostDateStruct":538,"startDateStruct":540,"completionDateStruct":542,"leadSponsor":544,"locationsCount":345},"100578016","predicting-clinical-outcomes-during-first-line-cdk46-inhibitors-plus-endocrine-therapy-in-patients-with-advanced-hormone-receptor-positive-her2-negative-breast-cancer-the-retrospective-prospective-multicenter-italian-palmares-2-study-100578016","NCT06805812","Predicting clinicAL outcoMes During First-line CDK4\u002F6 Inhibitors Plus Endocrine Therapy in Patients With Advanced Hormone REceptor-poSitive HER2-negative Breast Cancer: the Retrospective-prospective Multicenter Italian PALMARES-2 Study","Predictive Impact of Peripheral Blood Lymphocytes on clinicAL outcoMes During First-line CDK4\u002F6 Inhibitors Plus Endocrine Therapy in Patients With Advanced Hormone REceptor-poSitive HER2-negative Breast Cancer: the Retrospective-prospective Multicenter Italian PALMARES-2 Study","PALMARES-2","Inclusion Criteria:\n\n* Diagnosis of HR+\u002FHER2- advanced Breast Cancer (aBC), as defined as at least 1% estrogen receptor (ER) and\u002For progesterone receptor (PgR) positivity at IHC. HER2 negativity is defined on the basis of an IHC score of 0, 1+, or 2+ with absence of gene amplification at in situ hybridization (ISH) analyses.\n* Have received or are candidate to receive treatment with palbociclib, ribociclib or abemaciclib in combination with endocrine therapy as first-line treatment for HR+\u002FHER2- aBC.\n\nExclusion Criteria:\n\n* Less than 3 months of follow up from the CDK4\u002F6i start to the date of data cut-off;\n* Have received CDK4\u002F6i as monotherapy;\n* Have received CDK4\u002F6i as adjuvant treatment for localized disease.",{"count":491,"type":21},3500,"PALMARES-2 is a retrospective\u002Fprospective, observational, multicenter, population-based study, aiming at providing real-world evidences on HR+\u002FHER2- aBC patients treated with first-line CDK4\u002F6i plus ET. The present study has the objective to collect data coming from different sources, i.e. RWD, medical images and biological samples, from patients treated with CDK4\u002F6i as first-line of therapy for HR+\u002FHER2- aBC. In consideration of the complexity of data collected and different objectives of the study, this master protocol foresees different sub-studies, which encompasses different methodologies for data collection, data extraction and analyses.",[123,494,495,279,496,278,497,320,498,499,500,501,502,503,504,505,506,507,508,509,510,511,512,513,514,515,516,517,518,519,520,521,522,523,524,525,526,527,528,529,530],"Breast Cancer Stage IV","Breast Cancer, Metastatic","Breast Diseases","Breast Neoplasms, Male","Breast Cancer With Metastatic Bone Disease","Breast Cancers","Breast Neoplasm","Breast Tumors","HR+ HER2- Men, Pre\u002FPostmenopausal Advanced Breast Cancer","HR+ Advanced or Metastatic Breast Cancer","HR+\u002FHER2- Breast Cancer","HRpos Breast Neoplasms","HR-positive, HER2-negative Advanced Breast Cancer","HR-positive, HER2-negative and PIK3CA Mutation Advanced Breast Cancer","HR-positive Breast Cancer","Hormone Receptor-Positive Breast Cancer","Hormone Receptor Positive Breast Adenocarcinoma","Hormone Receptor Positive Breast Carcinoma","Hormone Receptor Positive Breast Neoplasms","Hormone Receptor Positive HER-2 Negative Breast Cancer","Hormone Receptor Positive Malignant Neoplasm of Breast","Hormone Receptor Positive Metastatic Breast Cancer","Hormone Receptor Positive, HER2 Negative Breast Cancer","Hormone Receptor Negative Breast Cancer","Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer","Hormone Receptor Positive Breast Cancer","Hormone Receptor Positive (ER+\u002FPR+, and Her2-) Metastatic Breast Cancer","Hormone Receptor Positive, HER2-negative Neoplasms","Hormone Receptor Positive, HER2-low Neoplasms","Hormone Receptor Positive (HR+), HER2-negative Breast Cancer","Hormone Receptor (HR)-Positive Breast Cancer","Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer","Palbociclib","Ribociclib","Abemaciclib","CDK4\u002F6 Inhibitor","CDK4\u002F6 Inhibitors",[532,533,526,527,528,534,535,536],"HR+\u002FHER2- Advanced Breast Cancer","HR+\u002FHER2- Metastatic Breast Cancer","CDK4\u002F6i","Cyclin-Dependent Kinase 4\u002F6 inhibitors","Metastatic Breast Cancer","2025-01-28",{"date":539,"type":132},"2025-02-03",{"date":541,"type":132},"2023-05-01",{"date":543,"type":21},"2040-12-31",{"name":545,"class":139},"Fondazione IRCCS Istituto Nazionale dei Tumori, Milano"]