[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"early-stage-breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:early-stage-breast-cancer":31},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,36,0,25,[9,47,78,105,128,150,187,211,241,263,301,327,362,390,416,439,477,505,517,529,559,582,609,635,662],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100053974","phase-2-cdk46-inhibitors-combined-with-endocrine-therapy-for-neoadjuvant-treatment-100053974",false,"NCT07366112","CDK4\u002F6 Inhibitors Combined With Endocrine Therapy for Neoadjuvant Treatment","CDK4\u002F6 Inhibitors Combined With Endocrine Therapy for Neoadjuvant Treatment of Breast Cancer: ctDNA-Guided Personalized Therapy","DNACDKHR","Inclusion Criteria:\n\n* 1.Female breast cancer patients aged ≥18 years and ≤75 years, either postmenopausal or premenopausal\u002Fperimenopausal; 2.Pathologically confirmed hormone receptor-positive (HR+), HER2-negative invasive breast cancer:\n\n  1. ER-positive and\u002For PR-positive defined as: ≥10% of tumor cells showing positive staining;\n  2. HER2-negative defined as: standard immunohistochemistry (IHC) result of 0\u002F1+; or IHC 2+ with negative in situ hybridization (ISH) (confirmed by the central pathology laboratory); 3. At least one evaluable lesion per RECIST 1.1, with clinical staging meeting:\n\n  \u003C!-- -->\n\n  1. T1c-2N0M0 with high-risk factors (Grade 3, or Grade 2 with Ki67 ≥20%);\n  2. T3N0M0;\n  3. Any TN+M0; 4.Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1; 5.Willing to participate in the study and voluntarily sign informed consent; 6.Agree to undergo ctDNA testing during treatment; 7.Adequate organ and bone marrow function defined as:\n\n  \u003C!-- -->\n\n  1. Absolute neutrophil count (ANC) ≥1,500\u002Fmm³ (1.5 × 10⁹\u002FL) (without granulocyte colony-stimulating factor \\[G-CSF\\] treatment within 14 days);\n  2. Platelet count (PLT) ≥100,000\u002Fmm³ (100 × 10⁹\u002FL) (without corrective therapy within 7 days);\n  3. Hemoglobin (Hb) ≥9 g\u002FdL (90 g\u002FL) (without corrective therapy within 7 days);\n  4. Serum creatinine ≤1.5× upper limit of normal (ULN) or creatinine clearance ≥60 mL\u002Fmin (without corrective therapy within 7 days);\n  5. Total bilirubin (TBIL) ≤1.5×ULN (without corrective therapy within 7 days);\n  6. Aspartate aminotransferase (AST\u002FSGOT) and alanine aminotransferase (ALT\u002FSGPT) ≤1.5×ULN (without corrective therapy within 7 days);\n  7. Cardiac function: left ventricular ejection fraction (LVEF) ≥55%; QTc interval corrected by Fridericia's formula (QTcF) \\\u003C470 msec on 12-lead ECG; Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to randomization and agree to use non-hormonal contraception from informed consent signing until 2 months after the last treatment.\n\nExclusion Criteria:\n\n* 1.Bilateral breast cancer; 2.Prior history of breast cancer (including ductal carcinoma in situ or invasive breast cancer); 3.Any prior antitumor therapy for the current breast cancer, including systemic therapies (endocrine, chemotherapy, immunotherapy, biological therapy) or local therapies (radiotherapy, vascular embolization, axillary lymph node biopsy); 4.Diagnosis of any malignancy within 5 years prior to randomization, except cured cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma of the skin; 5.History of severe pulmonary diseases (e.g., interstitial pneumonia); 6. HIV infection, acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA ≥500 IU\u002FmL), hepatitis C (HCV antibody-positive with HCV RNA above the lower limit of detection), or co-infection with HBV and HCV; 7.Within 6 months prior to randomization: myocardial infarction, severe\u002Funstable angina, NYHA Class ≥II heart failure, ≥Grade 2 persistent arrhythmia (per NCI CTCAE v5.0), atrial fibrillation of any grade, coronary\u002Fperipheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident (including transient ischemic attack), or symptomatic pulmonary embolism; 8.Severe active infection within 4 weeks prior to randomization (requiring intravenous antibiotics, antifungals, or antivirals) or unexplained fever \\>38.5°C during screening\u002Fbefore first dose; 9.Known allergy to any component of the study drugs; 10.Current participation in another interventional drug clinical study; 11.Pregnancy or lactation; 12.Refusal to comply with follow-up; 13.Other severe physical\u002Fmental illnesses or laboratory abnormalities that may increase study risk, interfere with results, or render the patient unsuitable per investigator judgment.","FEMALE","18 Years","75 Years",{"count":22,"type":23},158,"ESTIMATED","INTERVENTIONAL",[26],"PHASE2","Exploring the dynamics of ctDNA following neoadjuvant therapy with CDK4\u002F6 inhibitors combined with endocrine treatment, and its potential to guide de-escalation of adjuvant chemotherapy",[29,30,31,32,33],"Hormone Receptor-Positive Breast Cancer","High-risk Breast Cancer","Early-Stage Breast Cancer","HER2-negative Breast Cancer","ctDNA Monitoring","RECRUITING","2026-07-10",{"date":37,"type":38},"2026-07-13","ACTUAL",{"date":40,"type":38},"2026-04-20",{"date":42,"type":23},"2029-12-31",{"name":44,"class":45},"Peking University People's Hospital","OTHER",1,{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":55,"targetDuration":4,"studyType":24,"phases":57,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":73,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":77,"locationsCount":46},"100053782","phase-2-ctdna-guided-de-escalation-of-adjuvant-chemotherapy-with-dalpiciclib-in-hr-positiveher2-negative-breast-cancer-100053782","NCT06970912","ctDNA-Guided De-Escalation of Adjuvant Chemotherapy With Dalpiciclib in HR-Positive\u002FHER2-Negative Breast Cancer","A Prospective, Multicenter, Randomized, Open-Label Phase II Study of ctDNA-Guided De-Escalation of Adjuvant Chemotherapy With Dalpiciclib in HR-Positive\u002FHER2-Negative Breast Cancer","DNADalHR","Inclusion Criteria:\n\n* Female breast cancer patients aged ≥18 years and ≤75 years, either postmenopausal or premenopausal\u002Fperimenopausal;\n* Pathologically confirmed hormone receptor-positive (HR+), HER2-negative invasive breast cancer:\n\n  1. ER-positive and\u002For PR-positive defined as: ≥10% of tumor cells showing positive staining;\n  2. HER2-negative defined as: standard immunohistochemistry (IHC) result of 0\u002F1+; or IHC 2+ with negative in situ hybridization (ISH) (confirmed by the central pathology laboratory);\n* At least one evaluable lesion per RECIST 1.1, with clinical staging meeting:\n\n  1. T1c-2N0M0 with high-risk factors (Grade 3, or Grade 2 with Ki67 ≥20%);\n  2. T3N0M0;\n  3. Any TN+M0;\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;\n* Willing to participate in the study and voluntarily sign informed consent;\n* Agree to undergo ctDNA testing during treatment;\n* Adequate organ and bone marrow function defined as:\n\n  1. Absolute neutrophil count (ANC) ≥1,500\u002Fmm³ (1.5 × 10⁹\u002FL) (without granulocyte colony-stimulating factor \\[G-CSF\\] treatment within 14 days);\n  2. Platelet count (PLT) ≥100,000\u002Fmm³ (100 × 10⁹\u002FL) (without corrective therapy within 7 days);\n  3. Hemoglobin (Hb) ≥9 g\u002FdL (90 g\u002FL) (without corrective therapy within 7 days);\n  4. Serum creatinine ≤1.5× upper limit of normal (ULN) or creatinine clearance ≥60 mL\u002Fmin (without corrective therapy within 7 days);\n  5. Total bilirubin (TBIL) ≤1.5×ULN (without corrective therapy within 7 days);\n  6. Aspartate aminotransferase (AST\u002FSGOT) and alanine aminotransferase (ALT\u002FSGPT) ≤1.5×ULN (without corrective therapy within 7 days);\n  7. Cardiac function: left ventricular ejection fraction (LVEF) ≥55%; QTc interval corrected by Fridericia's formula (QTcF) \\\u003C470 msec on 12-lead ECG;\n* Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to randomization and agree to use non-hormonal contraception from informed consent signing until 2 months after the last treatment.\n\nExclusion Criteria:\n\n* HER2-positive breast cancer confirmed by current pathological diagnosis;\n* Inflammatory breast cancer;\n* Stage IV (metastatic) breast cancer;\n* Bilateral breast cancer;\n* Prior history of breast cancer (including ductal carcinoma in situ or invasive breast cancer);\n* Any prior antitumor therapy for the current breast cancer, including systemic therapies (endocrine, chemotherapy, immunotherapy, biological therapy) or local therapies (radiotherapy, vascular embolization, axillary lymph node biopsy);\n* Diagnosis of any malignancy within 5 years prior to randomization, except cured cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma of the skin;\n* History of severe pulmonary diseases (e.g., interstitial pneumonia);\n* HIV infection, acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA ≥500 IU\u002FmL), hepatitis C (HCV antibody-positive with HCV RNA above the lower limit of detection), or co-infection with HBV and HCV;\n* Within 6 months prior to randomization: myocardial infarction, severe\u002Funstable angina, NYHA Class ≥II heart failure, ≥Grade 2 persistent arrhythmia (per NCI CTCAE v5.0), atrial fibrillation of any grade, coronary\u002Fperipheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident (including transient ischemic attack), or symptomatic pulmonary embolism;\n* Severe active infection within 4 weeks prior to randomization (requiring intravenous antibiotics, antifungals, or antivirals) or unexplained fever \\>38.5°C during screening\u002Fbefore first dose;\n* Known allergy to any component of the study drugs;\n* Current participation in another interventional drug clinical study;\n* Pregnancy or lactation;\n* Refusal to comply with follow-up;\n* Other severe physical\u002Fmental illnesses or laboratory abnormalities that may increase study risk, interfere with results, or render the patient unsuitable per investigator judgment.",{"count":56,"type":23},393,[26],"* This is a Phase II, multicenter, randomized clinical trial evaluating a ctDNA-guided approach to de-escalate adjuvant chemotherapy in patients with hormone receptor (HR)-positive, HER2-negative early-stage breast cancer. The study aims to determine if combining the CDK4\u002F6 inhibitor Dalpiciclib with endocrine therapy can reduce the need for chemotherapy while maintaining clinical benefits.\n* Key Details ：\n\n  1. Participants: 393 women (aged 18-75) with early-stage HR+\u002FHER2- breast cancer at high risk of recurrence (e.g., tumor size ≥2 cm, lymph node involvement, or high-grade tumors).\n  2. Design: Patients are randomized 1:4 to two groups:\n\n     Group A (Chemotherapy) : Receives 4 cycles of taxane-based chemotherapy before surgery.\n\n     Group B (Experimental) : Receives Dalpiciclib + aromatase inhibitor (AI) for 4 cycles pre-surgery.\n\n     Post-surgery, treatment is adjusted based on ctDNA results.\n  3. Primary Goals ： Assess ctDNA clearance rate (conversion from detectable to undetectable ctDNA) after neoadjuvant therapy in Group B.\n\n     Evaluate 3-year event-free survival (EFS) in Group B (e.g., freedom from cancer recurrence, progression, or death).\n\n     Secondary Goals ： Safety of Dalpiciclib + endocrine therapy. Tumor response rates (e.g., complete cell cycle arrest, pathological remission).\n\n     Correlation between ctDNA clearance and long-term outcomes.\n* Why This Matters ： Current guidelines recommend chemotherapy for high-risk HR+ breast cancer, but it often causes significant side effects. This study explores a personalized approach using ctDNA-a blood-based biomarker-to identify patients who may safely avoid chemotherapy without compromising survival. If successful, it could shift clinical practice toward less toxic, targeted therapies for eligible patients.",[29,30,31,32,33,60],"Breast Cancer Early Stage Breast Cancer (Stage 1-3)",[62,63,64,65,66,67,68,69,70,71,72],"HR-positive HER2-negative breast cancer","Early-stage breast cancer","Dalpiciclib","CDK4\u002F6 inhibitor","ctDNA-guided therapy","Adjuvant chemotherapy de-escalation","Circulating tumor DNA (ctDNA)","Event-free survival (EFS)","Chemotherapy sparing","Personalized therapy","Biomarker-guided therapy",{"date":37,"type":38},{"date":75,"type":38},"2025-08-01",{"date":42,"type":23},{"name":44,"class":45},{"id":79,"slug":80,"hasResults":12,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":12,"sex":85,"minAge":19,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":24,"phases":88,"briefSummary":90,"conditions":91,"keywords":94,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":46},"100468971","cardiometabolic-screening-program-100468971","NCT05386719","Cardiometabolic Screening Program","A Cardiometabolic Screening Program for Breast Cancer Survivors","Inclusion Criteria:\n\n* Diagnosis of early stage breast cancer\n* Completed local and\u002For systemic therapy at least 3 months ago\n* Receiving medical oncology care at through the breast cancer clinics at Johns Hopkins Medical Institute, including the Sidney Kimmel Comprehensive Cancer Center in Baltimore MD and Green Spring Station in Lutherville-Timonium MD, and Sibley Memorial Hospital in Washington D.C.\n* Read and speak English\n\nExclusion Criteria:\n\n* Metastatic breast cancer","ALL",{"count":87,"type":23},450,[89],"NA","This research study is being done to implement a screening program for prediabetes, diabetes, dyslipidemia and\u002For hyperlipidemia, and higher risk of cardiovascular disease in breast cancer survivors. This program will also help to direct individuals with risk factors to community and institutional resources for management.",[92,93],"Breast Cancer","Early-stage Breast Cancer",[95],"Survivor","2026-06-22",{"date":98,"type":38},"2026-06-25",{"date":100,"type":38},"2022-06-03",{"date":102,"type":23},"2027-08-01",{"name":104,"class":45},"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins",{"id":106,"slug":107,"hasResults":12,"nctId":108,"briefTitle":109,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":12,"sex":85,"minAge":19,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":24,"phases":114,"briefSummary":115,"conditions":116,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":46},"100430898","phase-2-bre-04-window-of-opportunity-trial-of-preoperative-low-dose-azacitidine-in-high-risk-early-stage-breast-cancer-100430898","NCT04891068","BRE-04: Window of Opportunity Trial of Preoperative Low Dose Azacitidine in High-Risk Early Stage Breast Cancer","BRE-04","Inclusion Criteria:\n\n1. Age ≥ 18 years of age at time of consent\n2. ECOG 0, 1, or 2\n3. Histologically confirmed invasive breast carcinoma documented by biopsy. AJCC 8th edition clinical stage T1a-T3\u002FN0-N1\u002FM0 by physical exam or radiologic studies\n4. Disease characteristics I. TNBC (Less than or equal to 10% of tumor cells staining for ER and for PR by immunohistochemistry (IHC). HER2-negative, as defined by ASCO\u002FCAP guidelines)\n\nOR\n\nII. ER positive (as determined by immunohistochemistry (IHC)) and any of the following high risk characteristics:\n\n1. HER2 positive (IHC or FISH)\n2. Node positive\n3. Any clinical high-risk expression profile (mammaprint, oncotype, endopredict)\n4. PR negative (IHC) OR III. HER 2 positive (as defined by ASCO\u002FACP guidelines) f. Demonstrates adequate organ function as defined in table below. All screening labs to be obtained within 30 days prior to registration.\n\nSystem Laboratory Value Hematological Leukocytes ≥3,000\u002Fmm3 Platelet count ≥ 100,000\u002Fmm3 Absolute Neutrophil Count (ANC) ≥ 1,500\u002Fmm3 Hemoglobin (Hgb) ≥ 9.0 g\u002FdL Renal Creatinine\u002FCalculated creatinine clearance (CrCl) Cr \\\u003C 1.5 x upper limit of normal (ULN) or CrCl ≥ 50 mL\u002Fmin using the Cockcroft-Gault formula Hepatic Bilirubin Bilirubin ≤ 1.5 × ULN. Subjects with Gilbert's syndrome may have a bilirubin \\> 1.5 × ULN, if no evidence of biliary obstruction exists Aspartate aminotransferase (AST) ≤ 2.5 × ULN Alanine aminotransferase (ALT) ≤ 2.5 × ULN g. No evidence of distant metastases (M0 per AJCC staging guidelines) h. Provided written informed consent and HIPAA authorization for release of personal health information, via an approved UIC Institutional Review Board (IRB) informed consent form and HIPAA authorization.\n\ni. Women of childbearing potential must not be pregnant or breast-feeding. A negative serum or urine pregnancy test is required per institutional practice guidelines.\n\nj. As determined at the discretion of the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.\n\nExclusion Criteria:\n\n1. Previous anti-cancer treatment (cytotoxic chemotherapy, immunotherapy, biologic therapy, radiotherapy directed towards the primary breast tumor and\u002For ipsilateral axillary lymph nodes or investigational agents) with therapeutic intent for the current breast cancer.\n2. Any type of breast implants\n3. Active infection requiring systemic therapy\n4. Uncontrolled HIV\u002FAIDS or active viral hepatitis\n5. Pregnant or nursing\n6. Any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of this investigational regimen, as determined by the treating medical oncologist.\n7. Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial unless a Legal Authorized Representative (LAR) is in place to sign on behalf of the patient.\n8. Other major comorbidity, as determined by study PI",{"count":113,"type":23},40,[26],"To determine the effect of low dose azacitidine therapy on tumor infiltrating lymphocytes (TILs) in primary tumors from patients with high-risk early stage breast cancer, paired t-tests will be first used to compare TIL count in pre- and post-treatment specimens.",[117,93,118],"Breast Cancer Invasive","High Risk Breast Carcinoma","2026-06-18",{"date":121,"type":38},"2026-06-23",{"date":123,"type":38},"2022-01-10",{"date":125,"type":23},"2027-05",{"name":127,"class":45},"University of Illinois at Chicago",{"id":129,"slug":130,"hasResults":12,"nctId":131,"briefTitle":132,"officialTitle":132,"acronym":4,"eligibilityCriteria":133,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":134,"targetDuration":4,"studyType":24,"phases":136,"briefSummary":138,"conditions":139,"keywords":4,"overallStatus":142,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":46},"100641190","phase-1-bre-06-study-to-increase-tolerance-to-aromatase-inhibitors-for-patients-with-early-stage-hormone-receptor-positive-breast-cancer-who-developed-hypoactive-sexual-desire-disorder-100641190","NCT07596212","BRE-06: Study to Increase Tolerance to Aromatase Inhibitors for Patients With Early-Stage Hormone Receptor Positive Breast Cancer Who Developed Hypoactive Sexual Desire Disorder","Inclusion Criteria:\n\n* Females 18 or older\n* Histologically-proven, resected, hormone receptor-positive (defined as estrogen receptor ≥1% and\u002For progesterone receptor (PgR)≥1% by immunohistochemistry at local institutions) early invasive breast cancer, stage I-III per American Joint Committee of Cancer (AJCC) 8th edition, regardless of Human Epidermal growth factor Receptor 2 (HER2) status\n* Completion of the following planned cancer treatments prior to registration:\n\n  * Surgical resection of breast and nodal surgery; (NOTE: Reconstructive surgery does not have to be completed)\n  * Adjuvant radiation therapy, if needed\n  * Neoadjuvant and\u002For adjuvant chemotherapy if needed\n  * Treatment with anti-HER2 agents is allowed\n* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.\n* Ability to swallow oral medication.\n* Provide written informed consent and fill out questionnaires\n* Willing to return to the enrolling institution for follow-up\n* Women of childbearing potential must not be pregnant or breastfeeding. A negative serum or urine pregnancy test is required per institutional practice guidelines. Women of childbearing potential will be required to use effective contraception from the time of consent until 30 days after the last dose of bupropion. Acceptable methods include hormonal contraception, intrauterine device, barrier methods with spermicide, or sterilization\n\nExclusion Criteria:\n\n* Previous bilateral oophorectomy or ovarian irradiation; pregnant or lactating at the time of randomization or desiring pregnancy within 5 years.\n* History of psychiatric illnesses on active treatment\n* History or active suicidal thoughts or behaviors\n* Currently taking anti-depressants, anti-anxiety, or anti-psychotic medications. History of seizure disorder\n* History of bulimia or anorexia nervosa\n* Inhibitors or inducers of CYP2B6\n* Drugs metabolized by CYP2D6\n* Use of monoamine oxidase inhibitors (MAOI)\n* History of hypertension, regardless of control status.\n* History of angle closure glaucoma\n* Subjects taking levodopa, amantadine, methylene blue, and linezolid\n* Those with a hypersensitivity to bupropion, anastrozole, letrozole, exemestane, goserelin, or leuprolide. Currently receiving any of the following cancer-directed therapies:\n\n  * Radiation therapy\n  * Systemic therapy such as chemotherapy (standard or investigational)\n  * Anti-HER2 agents are allowed",{"count":135,"type":23},100,[137,26],"PHASE1","This study is open to women who have early-stage breast cancer and are on aromatase inhibitor (AI) therapy, and who have hypoactive sexual desire disorder (HSDD). HSDD is a persistent lack of physical desire for sex and a lack of sexual activity, or even sexual thoughts or fantasies, that causes you distress. The researchers want to determine if sexual functioning, as measured by responses on a sexual functioning questionnaire, is improved by adding Bupropion Extended Release (XL) to the AI treatment regimen. Bupropion XL is an FDA-approved medication for the treatment of major depressive disorder, seasonal affective disorder, and nicotine dependence. It has been studied in HSDD in pre- and post-menopausal healthy women, and has been demonstrated to be effective, but it has not been thoroughly studied in women with early-stage breast cancer on AI therapy.",[93,140,141,92],"Hypoactive Sexual Desire Disorder","Hormone Receptor Positive Breast Carcinoma","NOT_YET_RECRUITING","2026-06-16",{"date":119,"type":38},{"date":146,"type":23},"2026-07",{"date":148,"type":23},"2031-07",{"name":127,"class":45},{"id":151,"slug":152,"hasResults":12,"nctId":153,"briefTitle":154,"officialTitle":154,"acronym":155,"eligibilityCriteria":156,"healthyVolunteers":12,"sex":85,"minAge":19,"maxAge":157,"enrollmentInfo":158,"targetDuration":4,"studyType":160,"phases":4,"briefSummary":161,"conditions":162,"keywords":167,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":186},"100609178","evaluating-minimal-residual-disease-mrd-through-longitudinal-circulating-tumor-dna-ctdna-profiling-in-breast-malignancies-100609178","NCT07211178","Evaluating Minimal Residual Disease (MRD) Through Longitudinal Circulating Tumor DNA (ctDNA) Profiling in Breast Malignancies","GEMINI Breast","Inclusion Criteria:\n\nAll Cohorts:\n\n1. Willing and able to participate in the research and provide biospecimens\n2. Willing and able to provide informed consent\n3. Must be diagnosed with breast cancer\n\nCohort 1: Neoadjuvant Treatment Cohort 1A: Newly Diagnosed, High Risk HR+,HER2-\n\n1. A known or suspected HR+, HER2- breast cancer treated with curative intent (Stage II to III disease)\n2. Patients are considered at high risk of recurrence, defined as 4 or more positive axillary lymph nodes (ALNs), or between 1-3 positive ALNs and either grade 3 disease or tumor size of 5 cm or larger.\n\nCohort 1B: HER2+ 1. A known or suspected HER2+ breast cancer treated with curative intent (Stage II to III disease). Inclusive of HR+ or HR- patients.\n\nCohort 1C: Triple Negative Breast Cancer\n\n1\\. A known or suspected triple negative breast cancer treated with curative intent (Stage I to III disease).\n\nCohort 2: Adjuvant Therapy \u002F Surveillance Cohort 2A: Newly Diagnosed HR+,HER2-\n\n1. A known or suspected HR+, HER2- breast cancer treated with curative intent (Stage II to III disease)\n2. Patients are considered at high risk of recurrence, defined as 4 or more positive axillary lymph nodes (ALNs), or between 1-3 positive ALNs and either grade 3 disease or tumor size of 5 cm or larger.\n3. Have undergone curative intent surgery with no clinical evidence of disease.\n\nCohort 2B: HER2+\n\n1. A known or suspected HER2+ breast cancer treated with curative intent (Stage II to III disease)\n2. Have undergone curative intent surgery with no clinical evidence of disease.\n\nCohort 2C: Triple Negative Breast Cancer\n\n1. A known or suspected triple negative breast cancer treated with curative intent (Stage I to III disease)\n2. Have undergone curative intent surgery with no clinical evidence of disease.\n\nCohort 3: 5-Years Post-Diagnosis Surveillance (NED)\n\n1. A known HR+, HER2- breast cancer treated with curative intent (Stage II to III disease).\n2. No Evidence of Disease (NED) ≥ 5 years from initial diagnosis.\n3. Patients are considered at high risk of recurrence, defined as 4 or more positive axillary lymph nodes (ALNs), or between 1-3 positive ALNs and either grade 3 disease or tumor size of 5 cm or larger.\n\nExclusion Criteria:\n\n1. Not willing or able to adhere with the study procedures\n2. Active secondary malignancy\n3. Diagnosis of a malignancy within 3 years of breast cancer diagnosis Note: Ductal carcinoma in situ (DCIS, ipsilateral or contralateral) within 3 years is not excluded.","99 Years",{"count":159,"type":23},900,"OBSERVATIONAL","For patients with breast cancer, it's important to find any remaining cancer cells after they've had their main treatment. Even a few cells, called minimal residual disease (MRD), can lead to the cancer coming back later.\n\nA way to find these cells is by looking for tiny bits of cancer DNA that are shed into the blood. This is called circulating tumor DNA (ctDNA). A simple blood test, often called a liquid biopsy, can detect this ctDNA. This research aims to see if finding this cancer DNA in the blood can help predict if a patient's cancer will return. It also may help find out if the treatment is working.\n\nUltimately, the results of this research may help doctors better manage breast cancer and develop new and improved tests and treatments.",[92,163,164,165,166],"TNBC - Triple-Negative Breast Cancer","HR Positive\u002FHER-2 Negative Breast Cancer","HER2 + Breast Cancer","Early Stage Breast Cancer",[168,169,170,171,172,166,173,174,175],"Minimal Residual Disease","MRD","Next generation sequencing","NGS","ctDNA","TNBC - Triple Negative Breast Cancer","HR positive \u002F HER-2 negative breast cancer","HER2+ breast cancer","2026-06-10",{"date":178,"type":38},"2026-06-12",{"date":180,"type":38},"2025-10-27",{"date":182,"type":23},"2033-12",{"name":184,"class":185},"Tempus AI","INDUSTRY",14,{"id":188,"slug":189,"hasResults":12,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":4,"eligibilityCriteria":193,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":194,"targetDuration":4,"studyType":24,"phases":196,"briefSummary":197,"conditions":198,"keywords":199,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":46},"100538815","outcomes-and-cosmesis-with-whole-breast-irradiation-and-boost-100538815","NCT06295744","Outcomes and Cosmesis With Whole Breast Irradiation and Boost","Patient-Reported Outcomes and Cosmesis Following Five Fraction Whole Breast Irradiation With Simultaneous Integrated Boost","Inclusion Criteria:\n\n* Ability to understand and the willingness to sign a written informed consent document\n* Histologically confirmed early stage (stage T1-T2) invasive carcinoma of the breast or DCIS\n* Breast conserving surgery with negative margins and negative nodes (surgical axillary staging not mandatory), stage N0 or Nx\n* Treatment plan should include breast conserving surgery and adjuvant whole breast irradiation (WBI) therapy delivered with 3D-CRT or IMRT techniques\n* Treatment plan includes breast tumor bed boost\n* Willingness to comply with all study procedures and be available for the duration of the study\n\nExclusion Criteria:\n\n* Mastectomy of ipsilateral breast\n* Lack of histologic diagnosis\n* Histologic involvement of the axillary or regional nodes or metastatic disease\n* Accelerated partial breast irradiation treatment plan\n* Previous history of non-breast malignancy diagnosed in the past 5 years except for basal or squamous cell cancer of the skin\n* Previous history of chest radiation therapy\n* Previous history of ipsilateral breast cancer\n* Concurrent cytotoxic chemotherapy\n* Active connective tissue disease including scleroderma\n* Inability or unwillingness to return for required follow up visit",{"count":195,"type":23},50,[89],"This study is being done to evaluate cosmetic, patient-reported outcome measures (PROMs), and toxicities for women undergoing ultra-short whole breast irradiation (WBI) therapy with simultaneous integrated boost (SIB). 50 participants will be on study for up to 60 months.",[93],[200,201,202],"Cosmesis","Simultaneous Integrated Boost","Whole Breast Irradiation","2026-06-09",{"date":176,"type":38},{"date":206,"type":38},"2024-04-17",{"date":208,"type":23},"2032-02",{"name":210,"class":45},"University of Wisconsin, Madison",{"id":212,"slug":213,"hasResults":12,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":217,"eligibilityCriteria":218,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":219,"enrollmentInfo":220,"targetDuration":4,"studyType":24,"phases":222,"briefSummary":223,"conditions":224,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":46},"100484012","phase-2-fudan-university-shanghai-cancer-center-breast-cancer-precision-platform-series-study--neoadjuvant-therapy-100484012","NCT05582499","Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy","Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy (FASCINATE-N)","FASCINATE-N","Inclusion Criteria:\n\n* Histologically confirmed invasive breast cancer of clinical stage T1-4N1-3M0 or cT2-4N0M0;\n* Age between18-70 years;\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1;\n* ER, PR and HER2 status were measured by immunohistochemistry (IHC);\n* LVEF≥55%；\n* Definition of SNF subtypes: SNF subtypes confirmed by digital pathology of H\\&E slices;\n* Triple negative subtyping: On the basis of triple-negative pathological diagnosis, AR, cluster of differentiation 8 (CD8) and Forkhead Box C1 (FOXC1) were combined to define the subtyping;\n* At least one measurable lesion according to RECIST version 1.1\n* Normal organ and marrow function: Hemoglobin (HB) ≥90 g\u002FL (No blood was transfused within 14 days), Absolute neutrophil count ≥ 1500\u002FμL, Platelets ≥ 75,000\u002FμL, Total bilirubin ≤ 1.5 x ULN), aspartate aminotransferase (AST) (SGOT) and alanine aminotransferase (ALT) (SGPT) ≤ 3 x ULN, creatinine \\\u003C 1 x ULN, endogenous creatinine clearance \\> 50 ml\u002Fmin (Cockcroft-Gault formula);\n* Non-pregnant and non-lactating, fertile female subjects were required to use a medically approved contraceptive method for the duration of the study treatment and at least 3 months after the last use of the study drug;\n* Ability to understand and willingness to sign a written informed consent\n\nExclusion Criteria:\n\n* Previous cytotoxic chemotherapy, endocrine therapy, biological therapy or radiotherapy for any reason;\n* Patients with New York Heart Association (NYHA) grade II or above heart disease (including grade II);\n* Patients with severe systemic infections or other serious diseases;\n* Patients with known allergy or intolerance to the study drug or its excipients;\n* Other malignant tumors in the past 5 years, except cured cervical carcinoma in situ and non-melanoma skin cancer;\n* Pregnant or lactating patients of childbearing age who refused to take appropriate contraceptive measures during the course of the study;\n* Participated in other trial studies within 30 days before the administration of the first dose of the study drug;\n* Patients who were judged by the investigator to be unsuitable for this study.","70 Years",{"count":221,"type":23},716,[26],"The purpose of this study is to establish a prospective, single-center platform research based on clinical subtypes to explore precision neoadjuvant therapy in patients with operable breast cancer who met the indications for neoadjuvant chemotherapy and by the update of basic translational research in the center, especially the refinement of typing, the discovery of new targets and the development of novel targeted drugs, verified the effectiveness of new targeted drugs in neoadjuvant therapy.",[225,92,226,227,228,32,229,230,93,231],"Breast Neoplasm","Breast Tumors","Triple-Negative Breast Cancer (TNBC)","HER2-positive Breast Cancer","Hormone Receptor Positive Tumor","Hormone Receptor Negative Tumor","Locally Advanced Breast Cancer","2026-05-22",{"date":234,"type":38},"2026-05-28",{"date":236,"type":38},"2022-11-01",{"date":238,"type":23},"2029-09",{"name":240,"class":45},"Fudan University",{"id":242,"slug":243,"hasResults":12,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":4,"eligibilityCriteria":247,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":248,"targetDuration":4,"studyType":24,"phases":250,"briefSummary":252,"conditions":253,"keywords":4,"overallStatus":142,"whyStopped":4,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":255,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":4},"100641095","phase-4-trastuzumab-rezetecan-t-dxh-in-her2-breast-cancer-with-non-pcr-after-tcbhp-100641095","NCT07589699","Trastuzumab Rezetecan (T-DXh) in HER2+ Breast Cancer With Non-pCR After TCbHP","A Single-Arm, Exploratory Study of 4 Additional Cycles of Trastuzumab Rezetecan (T-DXh) as Neoadjuvant Therapy in Patients With Early or Locally Advanced HER2-Positive Breast Cancer Who Have Non-pCR After TCbHP Neoadjuvant Therapy","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* For premenopausal and perimenopausal patients: negative pregnancy test and agreement to use reliable contraception during the treatment period.\n* Pathologically confirmed HER2-positive invasive breast cancer (IHC 3+ or IHC 2+ with FISH+).\n* Completed standard neoadjuvant TCbHP (taxane + carboplatin + trastuzumab + pertuzumab) with imaging assessment not achieving clinical complete remission (non-cCR).\n* Agree to undergo a core needle biopsy.\n* ECOG performance status 0 or 1.\n* Adequate organ function meeting the following criteria: hemoglobin ≥ 90 g\u002FL, white blood cell count ≥ 3.5 × 10\\^9\u002FL, platelet count ≥ 100 × 10\\^9\u002FL, absolute neutrophil count ≥ 1.5 × 10\\^9\u002FL, AST\u002FALT ≤ 3 × ULN, total bilirubin ≤ 1.5 × ULN, serum creatinine ≤ 1.5 × ULN.\n* No myocardial ischemia on ECG; New York Heart Association (NYHA) functional class I; left ventricular ejection fraction (LVEF) ≥ 55% by echocardiography; cardiac troponin I (cTnI) and brain natriuretic peptide (BNP) within normal limits.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Male breast cancer or inflammatory breast cancer.\n* Metastatic breast cancer (Stage IV).\n* Concurrent other malignancy or history of other malignancy within the past 5 years, except adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.\n* Concurrent other anti-tumor therapy or participation in another clinical trial.\n* Severe non-malignant disease that would affect compliance or place the patient at risk.\n* Major surgery within 4 weeks prior to start of study treatment or anticipated need for major surgery during the study.\n\nHistory of allergic reaction or contraindication to any component of the study drug.\n\n* Dementia, mental abnormality, or any psychiatric illness that interferes with understanding of the informed consent.\n* Any other condition assessed by the investigator as unsuitable for inclusion.",{"count":249,"type":23},59,[251],"PHASE4","This is a prospective, multi-center, single-arm, phase 2 exploratory study to evaluate the efficacy and safety of adding 4 cycles of Trastuzumab Rezetecan (T-DXh), an anti-HER2 antibody-drug conjugate, as continued neoadjuvant therapy in patients with early or locally advanced HER2-positive breast cancer who have residual invasive disease after standard 6-cycle TCbHP (taxane, carboplatin, trastuzumab, pertuzumab) neoadjuvant therapy. Patients will receive 4 cycles of T-DXh (4.8 mg\u002Fkg IV Q3W) followed by radical surgery. The primary endpoint is tpCR rate. Secondary endpoints include ORR, EFS, OS, 3-year iDFS, and safety. Simon's two-stage design (H0: pCR ≤10%, H1: pCR ≥25%, α=0.05, β=0.2) requires 43 evaluable patients; with 10% dropout, 48 patients will be enrolled.",[92,228,93,231],"2026-05-11",{"date":256,"type":38},"2026-05-15",{"date":258,"type":23},"2026-05-31",{"date":260,"type":23},"2031-12-31",{"name":262,"class":45},"The First Affiliated Hospital with Nanjing Medical University",{"id":264,"slug":265,"hasResults":12,"nctId":266,"briefTitle":267,"officialTitle":268,"acronym":269,"eligibilityCriteria":270,"healthyVolunteers":12,"sex":85,"minAge":19,"maxAge":4,"enrollmentInfo":271,"targetDuration":4,"studyType":24,"phases":273,"briefSummary":274,"conditions":275,"keywords":278,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":291,"lastUpdatePostDateStruct":292,"startDateStruct":294,"completionDateStruct":296,"leadSponsor":298,"locationsCount":300},"100136130","phase-2-i-spy-trial-neoadjuvant-and-personalized-adaptive-novel-agents-to-treat-breast-cancer-100136130","NCT01042379","I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer","I-SPY Trial (Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis 2)","I-SPY","Inclusion Criteria:\n\n* Histologically confirmed invasive cancer of the breast\n* Clinically or radiologically measureable disease in the breast after diagnostic biopsy, defined as longest diameter greater than or equal to 25 mm (2.5cm)\n* No prior cytotoxic regimens are allowed for this malignancy. Patients may not have had prior chemotherapy or prior radiation therapy to the ipsilateral breast for this malignancy. Prior bis-phosphonate therapy is allowed\n* Age ≥18 years\n* ECOG performance status 0-1\n* Willing to undergo core biopsy of the primary breast lesion to assess baseline biomarkers\n* Non-pregnant and non-lactating\n* No ferromagnetic prostheses. Patients who have metallic surgical implants that are not compatible with an MRI machine are not eligible.\n* Ability to understand and willingness to sign a written informed consent (I-SPY TRIAL Screening Consent)\n* Eligible tumors must meet one of the following criteria: Stage II or III, or T4, any N, M0, including clinical or pathologic inflammatory cancer or Regional Stage IV, where supraclavicular lymph nodes are the only sites metastasis\n* Any tumor ER\u002FPgR status, any HER-2\u002Fneu status as measured by local hospital pathology laboratory and meets any tumor assay profile described in protocol section 4.1.2F\n* Normal organ and marrow function: Leukocytes ≥ 3000\u002FμL, Absolute neutrophil count ≥ 1500\u002FμL, Platelets ≥ 100,000\u002FμL, Total bilirubin within normal institutional limits, unless patient has Gilbert's disease, for which bilirubin must be ≤ 2.0 x ULN, AST(SGOT)\u002FALT (SGPT) ≤ 1.5 x institutional ULN, creatinine \\\u003C 1.5 x institutional ULN\n* No uncontrolled or severe cardiac disease. Baseline ejection fraction (by nuclear imaging or echocardiography) must by ≥ 50%\n* No clinical or imaging evidence of distant metastases by PA and Lateral CXR, Radionuclide Bone scan, and LFTs including total bilirubin, ALT, AST, and alkaline phosphatase\n* Tumor assay profile must include on of the following: MammaPrint High, any ER status, any HER2 status, or MammaPrint Low, ER negative (\\\u003C5%), any HER2 status, or MammaPrint Low, ER positive, HER2\u002Fneu positive by any one of the three methods used (IHC, FISH, TargetPrint™)\n* Ability to understand and willingness to sign a written informed consent document (I-SPY 2 TRIAL Consent #2)\n\nExclusion Criteria:\n\n* Use of any other investigational agents within 30 days of starting study treatment\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study agent or accompanying supportive medications.\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",{"count":272,"type":23},5000,[26],"The purpose of this study is to further advance the ability to practice personalized medicine by learning which new drug agents are most effective with which types of breast cancer tumors and by learning more about which early indicators of response (tumor analysis prior to surgery via magnetic resonance imaging (MRI) images along with tissue and blood samples) are predictors of treatment success.",[276,92,226,277,163,228,32,229,230,93,231],"Breast Neoplasms","Angiosarcoma",[279,280,281,282,283,284,285,286,287,288,289,290],"Neoadjuvant","Breast","Cancer","Neoplasm","Adaptive","pCR","Pathologic Complete Response","Biomarkers signature","MRI Volume","Endocrine Therapy","Chemotherapy","Immunotherapy","2026-05-04",{"date":293,"type":38},"2026-05-06",{"date":295,"type":38},"2010-03-01",{"date":297,"type":23},"2031-12",{"name":299,"class":45},"QuantumLeap Healthcare Collaborative",42,{"id":302,"slug":303,"hasResults":12,"nctId":304,"briefTitle":305,"officialTitle":306,"acronym":4,"eligibilityCriteria":307,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":308,"targetDuration":4,"studyType":24,"phases":310,"briefSummary":311,"conditions":312,"keywords":315,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":319,"startDateStruct":321,"completionDateStruct":322,"leadSponsor":324,"locationsCount":326},"100575180","phase-2-biolosion-combined-standard-neoadjuvant-therapy-to-treat-triple-negative-breast-cancer-100575180","NCT06768931","Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer","A Multicenter, Randomized Controlled Phase II Clinical Study of Standard Neoadjuvant Therapy Combined With Biolosion (Oral Probiotic Compound Preparation) in Triple-negative Breast Cancer","Inclusion Criteria:\n\n1. Women aged 1.18 years and above, diagnosed with triple-negative breast cancer (ER≤10%, PR≤10%, HER-2 negative) by pathology;\n2. Patients must have tumor specimens (formalin-fixed, paraffin-embedded, or fresh pre-treated tumor tissue) available for PD-L1 expression testing;\n3. Researchers assess indications for neoadjuvant chemotherapy, with staging from IIA to IIIC, based on imaging or pathological evaluation of cT1c, N1-3, or cT2\\~cT4, cN0\\~N3, and patients with no distant metastasis as evaluated by imaging;\n4. Patients must not have received chemotherapy or targeted therapy for advanced breast cancer;\n5. ECOG PS: 0-2;\n6. Expected survival of ≥12 weeks;\n7. Major organ function levels must meet the following criteria:\n\n1\\) Hematological examination standards must meet: ANC≥1.5×10\\^9\u002FL, PLT≥75×10\\^9\u002FL, Hb≥90g\u002FL (no blood transfusions or blood products within 14 days, and no use of G-CSF or other hematopoietic growth factors for correction) 2) Biochemical examination must meet the following standards: TBIL\\\u003C1.5×ULN, ALT, AST\\\u003C2.5×ULN, for patients with liver metastasis, ALT, AST may be \\\u003C5×ULN, BUN and Cr≤1×ULN or endogenous creatinine clearance ≥50ml\u002Fmin (Cockcroft-Gault formula); 8. Women of childbearing age must have taken reliable contraceptive measures or undergone a pregnancy test (serum or urine) within 7 days prior to enrollment, with a negative result, and must be willing to use appropriate contraceptive methods during the trial and for 8 weeks after the last administration of the investigational drug.\n\n9\\. Participants voluntarily join this study, demonstrate good compliance, and cooperate with follow-up.\n\nExclusion Criteria:\n\n1. There is a clear distant transfer;\n2. A history of autoimmune diseases;\n3. Acute or chronic active hepatitis B (defined as positive hepatitis B surface antigen and\u002For hepatitis B core antibody, with hepatitis B virus DNA copy number ≥1×10³ copies\u002Fml or ≥200 IU\u002Fml) or positive antibodies for acute or chronic active hepatitis C, with positive hepatitis C antibodies but negative RNA testing allowed for enrollment.\n4. Previous treatment with immune checkpoint inhibitors;\n5. Received systemic immunostimulants, systemic corticosteroids, or immunosuppressants within the last 4 weeks;\n6. Any severe underlying disease, comorbidities, and active infections, or patients with severe metabolic disorders;\n7. Currently receiving other antitumor treatments;\n8. Known comorbidities (e.g., chronic diarrhea, inflammatory bowel disease, etc.) that, in the investigator's assessment, would increase the risk associated with the administration of the study drug or interfere with the interpretation of study results.\n9. Currently using or planning to use probiotics, yogurt, or bacterial-enhanced foods during the treatment period.\n10. A history of epilepsy or seizure-inducing states;\n11. Pregnant or breastfeeding patients;\n12. Poor compliance or inability to undergo normal follow-up;\n13. Individuals allergic to the study drug;\n14. Diagnosis of other malignancies within the past 5 years, with the exception of: surgically removed non-melanoma skin cancer, adequately treated cervical carcinoma in situ, locally curative prostate cancer, surgically treated ductal carcinoma in situ, or malignancies diagnosed 2 years prior to randomization without evidence of disease and untreated for ≤2 years;\n15. The investigator's judgment on other conditions that may affect the conduct of the clinical study and the determination of study results.",{"count":309,"type":23},192,[26],"To evaluate the efficacy and safety of compound preparation Biolosion in combination with standard neoadjuvant therapy for locally advanced triple-negative breast cancer",[92,313,166,290,314],"Triple Negative Breast Cancer (TNBC)","Probiotic",[316,317,290],"Triple negative breast cancer","Probiotics","2026-03-26",{"date":320,"type":38},"2026-04-01",{"date":320,"type":23},{"date":323,"type":23},"2035-02-08",{"name":325,"class":45},"Sun Yat-sen University",5,{"id":328,"slug":329,"hasResults":12,"nctId":330,"briefTitle":331,"officialTitle":331,"acronym":332,"eligibilityCriteria":333,"healthyVolunteers":12,"sex":18,"minAge":334,"maxAge":4,"enrollmentInfo":335,"targetDuration":4,"studyType":24,"phases":337,"briefSummary":338,"conditions":339,"keywords":342,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":354,"startDateStruct":356,"completionDateStruct":358,"leadSponsor":360,"locationsCount":46},"100585434","phase-2-ultra-hypo-fractionated-adjuvant-whole-breast-radiation-therapy-with-simultaneous-integrated-boost-for-early-stage-breast-cancer-h-assist-100585434","NCT06902311","Ultra Hypo-fractionated Adjuvant Whole Breast Radiation Therapy With Simultaneous Integrated Boost for Early-Stage Breast Cancer (H-ASSIST)","H-ASSIST","In order to participate in this study a subject must meet all of the eligibility criteria outlined below.\n\nInclusion Criteria:\n\n* Willing and able to provide written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.\n* Women ≥ 50 years of age with confirmed de novo invasive carcinoma of breast or ductal carcinoma in situ.\n* Subjects with completed breast-conserving surgery (BCS) with or without sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND).\n* Subjects planned to receive either SOC whole breast 3D conformal radiation therapy (3D CRT) or SOC whole breast intensity modulated radiation therapy (IMRT) with standard dose tumor bed boost.\n* Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial, per the discretion of the treating radiation oncologist.\n* Enrollment in another clinical trial is allowed if there is no interference with interventions on this trial per discretion of the Principal Investigator.\n\nExclusion Criteria:\n\n* Receipt of concurrent breast reduction involving tissue rearrangement in the lumpectomy cavity (so that boost cannot be accurately targeted).\n* Synchronous bilateral breast cancer requiring bilateral radiation therapy.\n* Clinical or imaging evidence of distant metastases.\n* Prior ipsilateral breast or thoracic radiation.\n* Autoimmune conditions\n* Collagen Vascular Disease (such as systemic lupus erythematosus, scleroderma, dermatomyositis, among others)\n* Patients with pT4 tumors.\n* Patients recommended to receive regional nodal irradiation with associated radiation risks","50 Years",{"count":336,"type":23},90,[26],"This study evaluates the rates of radiation-specific toxicity, quality of life, and oncologic outcomes for early-stage breast cancer and ductal carcinoma in situ treated with 5-fraction whole breast irradiation (WBI) with a simultaneous integrated tumor bed boost (SIB). SIB refers to the technique tumor bed boost given at the same time as standard radiation therapy.\n\nThe FAST-Forward trial previously showed that a 1-week course of radiotherapy had similar effects to the traditional 3-week course for early-stage breast cancer after surgery. Given these favorable results, a 5-fraction WBI regimen is appealing for many patients who wish to minimize the number of treatment visits while still reducing their risk of recurrence. Generally, tumor bed boosts further decrease the risk of recurrence, but in the setting of 5-fraction WBI, a more traditional sequential boost technique is utilized.",[92,93,340,341],"Ductal Carcinoma in Situ","DCIS",[343,344,345,346,347,348,349,350,351,352],"whole breast irradiation","WBI","simultaneous integrated tumor bed boost (SIB)","SIB","Concurrent boost","adverse effects","toxicity","Radiation-specific toxicity","patient reported outcome","PRO-CTCAE","2026-03-24",{"date":355,"type":38},"2026-03-30",{"date":357,"type":38},"2025-02-19",{"date":359,"type":23},"2028-02",{"name":361,"class":45},"UNC Lineberger Comprehensive Cancer Center",{"id":363,"slug":364,"hasResults":12,"nctId":365,"briefTitle":366,"officialTitle":367,"acronym":4,"eligibilityCriteria":368,"healthyVolunteers":12,"sex":18,"minAge":369,"maxAge":370,"enrollmentInfo":371,"targetDuration":4,"studyType":24,"phases":373,"briefSummary":374,"conditions":375,"keywords":376,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":381,"startDateStruct":383,"completionDateStruct":385,"leadSponsor":387,"locationsCount":389},"100397700","exercise-therapy-to-improve-cardiovascular-health-in-post-menopausal-women-after-treatment-for-early-stage-breast-cancer-100397700","NCT04458532","Exercise Therapy to Improve Cardiovascular Health in Post-Menopausal Women After Treatment for Early Stage Breast Cancer","A Randomized Trial to Minimize Non-Response to Aerobic Training in Post-Menopausal Women With Early Stage Breast Cancer","Inclusion Criteria:\n\n* Aged 21-80 years\n* Female\n* Surgically resected early stage (I-III) primary breast cancer\n* Post-menopausal, defined as one of the following:\n\n  * Age ≥ 45 with no menses for at least 2 years\n  * Chemically and\u002For surgically induced menopause through ovarian suppression, as determined by the primary oncologist\n  * Estradiol level of ≤30 pg\u002FmL\n* An interval of at least one year, but no more than five years, following the full completion of definitive therapy for malignant disease. Definitive therapy is defined as:\n\n  * Surgery plus radiation\n  * Surgery plus chemotherapy\n  * Surgery plus trastuzumab\n* Exercise intolerance (i.e., patients must have a VO2peak below the predicted for active age and sex-matched individuals. (+\u002F- the technical error of 1.32 mL\u002Fkg\u002Fmin)\\].\n\nNote: Normative values are available up to 80 years of age)\n\n* Able to complete an acceptable baseline CPET, in the absence of high-risk ECG findings or other inappropriate response to exercise as determined by the PI, as defined by any of the following criteria:\n\n  * Achieving a plateau in oxygen consumption, concurrent with an increase in power output;\n  * A respiratory exchange ratio ≥ 1.10;\n  * Attainment of maximal predicted heart rate (HRmax) (i.e., within 10 bpm of age-predicted HRmax \\[HRmax = 220-Age\\[years\\]);\n  * Volitional exhaustion, as measured by a rating of perceived exertion (RPE) ≥ 18 on the BORG scale\n* Willingness to comply with all study-related procedures.\n\nExclusion Criteria:\n\n* Any of the following absolute contraindications to cardiopulmonary exercise testing:\n\n  * Acute myocardial infarction within 3-5 days of any planned study procedures\n  * Unstable angina\n  * Uncontrolled arrhythmia causing symptoms or hemodynamic compromise\n  * Recurrent syncope\n  * Active endocarditis\n  * Acute myocarditis or pericarditis\n  * Symptomatic severe aortic stenosis\n  * Uncontrolled heart failure\n  * Acute pulmonary embolus or pulmonary infarction within 3 months of any planned study procedures\n  * Thrombosis of lower extremities\n  * Suspected dissecting aneurysm\n  * Uncontrolled asthma\n  * Pulmonary edema\n  * Respiratory failure\n  * Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (e.g., infection, renal failure, thyrotoxicosis)\n* Presence of any other concurrent, actively treated malignancy\n* History of any other malignancy treated within the past 3 years (other than non-melanoma skin cancer)\n* Presence of distant metastatic disease (i.e., stage IV)\n* Room air desaturation at rest ≤ 85%\n* Mental impairment leading to inability to cooperate.\n* Any other condition or intercurrent illness that, in the opinion of the investigator, makes the participant a poor candidate for the trial.","21 Years","80 Years",{"count":372,"type":23},152,[89],"This study will compare the effects on cardiorespiratory fitness (CRF) of aerobic exercise in different amounts (number of minutes\u002Fsession) over different periods of time (number of weeks). Aerobic exercise is physical activity of light-to-moderate intensity that uses the large muscle groups (muscles in your legs, buttocks, back, and chest) and can be performed for at least 10 minutes.\n\nThe researchers will study the effects of different exercise programs on how well the study participants' bodies use oxygen, how well their heart pumps blood, how well their lungs function, and how healthy their blood vessels are.",[166],[377,378,379,380],"Exercise Therapy","Aerobic Training","Post-Menopausal Women","20-130",{"date":382,"type":38},"2026-03-25",{"date":384,"type":38},"2020-10-08",{"date":386,"type":23},"2027-03-31",{"name":388,"class":45},"Memorial Sloan Kettering Cancer Center",2,{"id":391,"slug":392,"hasResults":12,"nctId":393,"briefTitle":394,"officialTitle":395,"acronym":396,"eligibilityCriteria":397,"healthyVolunteers":12,"sex":18,"minAge":398,"maxAge":4,"enrollmentInfo":399,"targetDuration":4,"studyType":24,"phases":401,"briefSummary":403,"conditions":404,"keywords":405,"overallStatus":142,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":409,"startDateStruct":411,"completionDateStruct":412,"leadSponsor":414,"locationsCount":4},"100630155","phase-3-cryoablation-versus-lumpectomy-in-early-stage-breast-cancer-100630155","NCT07483996","Cryoablation Versus Lumpectomy in Early-Stage Breast Cancer","Cryoablation as Alternative for Lumpectomy in Early-Stage Breast Cancer: The CRYSTAL Trial","CRYSTAL","Inclusion Criteria:\n\n1. Women\n2. Age \\> 60 years\n3. Postmenopausal (no menstrual period for at least 12 months or in case of an intra-uterine device (IUD) hormone levels that indicate the menopause: follicle stimulating hormone (FSH) \\> 20 IE\u002Fl and estradiol \\\u003C 100 pmol\u002Fl)\n4. Histopathological confirmed primary invasive ER+\u002FHER2- type breast cancer\n5. Bloom Richardson grade 1 or 2 (low or intermediate malignancy grade)\n6. Unilateral and unifocal breast cancer\n7. A clinical T1N0M0 tumor (≤ 2cm and N0 on US and\u002For MRI), without distant metastases. The largest diameter measured will be used to determine eligibility.\n8. Tumor should be visible and well delineated (all borders of the tumor should be visible) on ultrasound at diagnosis and during the procedure.\n9. Sufficient knowledge of the Dutch language to complete the questionnaires\n10. To be able to give written informed consent\n\nExclusion Criteria:\n\n1. History of invasive breast cancer\n2. Breast augmentation\n3. BRCA-1 or 2 gene mutation carrier\n4. Lobular carcinoma\n5. Triple negative breast cancer\n6. Multifocality\n7. HER2-neu overexpressing tumors\n8. Lymph vascular invasion (LVI) on core needle biopsy or histopathological confirmed after lumpectomy\n9. Indication for neoadjuvant systemic therapy\n10. Intraductal component \\> 25% of the diameter of the invasive tumor on MRI, complete area of the primary tumor should not exceed 2cm.\n11. Allergic to local anesthetics\n12. Electrical devices and\u002For implants that are not compatible with MRI\n13. Current severe breast infection\n14. Uncorrectable coagulopathy\n15. Hemodynamic instability\n16. Respiratory instability\n17. Refraining from adjuvant radiotherapy\n18. Indication for oncoplastic surgery (surgical volume replacement techniques e.g. LICAP)","60 Years",{"count":400,"type":23},938,[402],"PHASE3","The goal of this randomised controlled trial is to compare ipsilateral breast cancer recurrence rates in patients with early-stage breast cancer between patients treated with breast conserving surgery and patient treated with percutaneous cryo-ablation.",[31],[92,31,406,407],"Borstkanker","Vroegstadium Borstkanker","2026-03-16",{"date":410,"type":38},"2026-03-19",{"date":320,"type":23},{"date":413,"type":23},"2038-12-31",{"name":415,"class":45},"Franciscus Gasthuis & Vlietland (Hospital)",{"id":417,"slug":418,"hasResults":12,"nctId":419,"briefTitle":420,"officialTitle":421,"acronym":422,"eligibilityCriteria":423,"healthyVolunteers":12,"sex":85,"minAge":19,"maxAge":4,"enrollmentInfo":424,"targetDuration":4,"studyType":24,"phases":426,"briefSummary":427,"conditions":428,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":429,"lastUpdatePostDateStruct":430,"startDateStruct":432,"completionDateStruct":434,"leadSponsor":436,"locationsCount":438},"100550423","diagnostic-her2dx-guided-treatment-for-patients-with-early-stage-her2-positive-breast-cancer-100550423","NCT06446882","Diagnostic HER2DX-guided Treatment for Patients wIth Early-stage HER2-positive Breast Cancer","Diagnostic HER2DX-guided Treatment for patIents wIth Early-stage HER2-positive Breast Cancer","DEFINITIVE","Inclusion Criteria:\n\n1. Signed informed consent must be obtained prior to any trial-specific procedure. Note: Candidate patients in France must be affiliated to a Social Security System (or equivalent).\n2. Male\u002Ffemale patients who are at least 18 years of age on the day of signing informed consent.\n3. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n4. Eligible for any of the following drugs: taxane, carboplatin, trastuzumab, pertuzumab and T-DM1 therapy.\n5. Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast untreated and recently diagnosed.\n6. Stage at presentation: cT1 cN1-2 or cT2-3 cN0-2 as determined by AJCC staging system, 8th edition (specifically in accordance with Anatomic Stage group rules).\n\n   Note: Axillary lymph node status must be assessed by fine needle biopsy or core biopsy. This procedure at screening will be omitted if there is no suspicion for positive axillary lymph node(s) radiographically or if a pathological report of suspicious lymph nodes of the results of a fine needle biopsy or core biopsy is available prior to the screening period.\n7. Absence of distant metastasis (i.e., cM0).\n8. Patients with multifocal tumors (more than one mass confined to the same quadrant as primary tumor) are eligible provided at least one focus is sampled and locally confirmed as HER2-positive.\n9. Patients with multicentric tumors (multiple tumors involving more than one quadrant) are eligible provided all discrete lesions are sampled and locally confirmed as HER2-positive.\n\n   Note: In patients with multifocal or multicentric breast cancer, the largest lesion should be measured to determine T stage and to performe the HER2DX test.\n10. HER2 positivity defined as either of the following: IHC 3+ or HER2 2+\u002F ISH positive as per most recent ASCO- CAP guideline according to the local laboratory as determined on the most recently analyzed tissue sample.\n11. ER\u002FPR status determined local based on pretreatment breast biopsy material according to the most recent ASCO\u002FCAP guidelines.\n12. Candidates for neoadjuvant treatment.\n13. Patient agreement to undergo appropriate surgical management, including axillary lymph node surgery and partial or total mastectomy, after completion of neoadjuvant treatment\n14. Baseline left ventricular ejection fraction (LVEF) ≥ 50% measured by echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scans.\n15. Availability of pre-treatment tumor tissue sample of FFPE tumor block from primary tumor in the breast for diagnostic HER2DX test. The tumor tissue should be of good quality based on total and viable tumor content and must be evaluated centrally for quality prior to enrollment. Archival tumor tissue or ex professo biopsy are acceptable.\n16. Adequate hematologic and end-organ function.\n17. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs, as defined below:\n\n    * Women must remain abstinent or use contraceptive methods with a failure rate of \\\u003C 1% per year during the treatment period, 6 months after the final dose of doxorubicin, 12 months after the final dose of cyclophosphamide, 6 months after the final dose of paclitaxel, and 7 months after the final dose of trastuzumab, pertuzumab, or T-DM1, whichever occurs last. Women must refrain from donating eggs during this same period.\n    * A woman is of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (\\> 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and\u002For uterus). The definition of childbearing potential may be adapted for alignment with local guidelines or requirements.\n    * Examples of contraceptive methods with a failure rate of \\\u003C 1% per year include bilateral tubal ligation, male sterilization, copper intrauterine devices, hormonal contraceptives that inhibit ovulation, and hormone-releasing intrauterine devices in women with hormone receptor-negative tumors only; the use of hormonal contraceptives and hormone releasing intrauterine devices are prohibited in women with hormone receptor-positive tumors.\n    * The reliability of sexual abstinence should be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.\n18. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below:\n\n    * With a female partner of childbearing potential who is not pregnant, men who are not surgically sterile must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \\\u003C 1% per year during the treatment period and for 6 months after the final dose of doxorubicin and\u002For cyclophosphamide, 6 months after the final dose of paclitaxel, and 7 months after the final dose of trastuzumab, pertuzumab, or T-DM1, whichever occurs last. Men must refrain from donating sperm during this same period. Male patients are encouraged to seek advice regarding cryoconservation of sperm prior to commencing study treatment because of the possibility of infertility with CT.\n    * With a pregnant female partner, men must remain abstinent or use a condom during the treatment period and for 6 months after the final dose of doxorubicin and\u002For cyclophosphamide, 6 months after the final dose of paclitaxel, and 7 months after the final dose of trastuzumab, pertuzumab, or T-DM1, whichever occurs last to avoid exposing the embryo.\n    * The reliability of sexual abstinence should be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.\n\nExclusion Criteria:\n\n1. Stage IV (metastatic) breast cancer.\n2. Known hypersensitivity to any of the excipients of trastuzumab, pertuzumab, carboplatin, T-DM1, docetaxel or paclitaxel.\n3. Patients with synchronous bilateral invasive breast cancer.\n4. Prior systemic therapy for treatment of breast cancer.\n5. Ulcerating or inflammatory breast cancer.\n6. Undergone incisional and\u002For excisional biopsy of primary tumor and\u002For axillary lymph nodes.\n7. Sentinel lymph node procedure or axillary lymph node dissection prior to initiation of neoadjuvant therapy.\n8. Patients with a history of previous breast cancer are excluded. Patients with a history of any other cancers (except non-melanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission with no therapy for a minimum of 3 years are excluded. For patients with a history of other non-breast cancerscancerscancers within 3 years and considered of low risk of recurrence per investigator's judgment (for example, papillary thyroid cancer treated with surgery), eligibility is to be discussed with the Sponsor.\n9. Cardiopulmonary dysfunction as defined by any of the following prior to randomization:\n\n   * History of congestive heart failure of any classification.\n   * Angina pectoris requiring anti-anginal medication, serious cardiac arrhythmia not controlled by adequate medication, severe conduction abnormality, or clinically significant valvular disease.\n   * High-risk uncontrolled arrhythmias (i.e., atrial tachycardia with a heart rate \\> 100\u002Fmin at rest, significant ventricular arrhythmia \\[ventricular tachycardia\\], or higher-grade atrioventricular \\[AV\\]-block \\[second degree AV-block Type 2 \\[Mobitz 2\\] or third-degree AV-block\\]).\n   * Significant symptoms (Grade \\> 1) relating to left ventricular dysfunction, cardiac arrhythmia, or cardiac ischemia.\n   * Myocardial infarction within 12 months prior to randomization.\n   * Evidence of transmural infarction on ECG.\n   * Requirement for oxygen therapy.\n   * Dyspnea at rest.\n10. Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment or anticipation of need for a major surgical procedure during the Study.\n11. Severe infection within 4 weeks prior to initiation of Study treatment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.\n12. History of significant co-morbidities that, in the judgment of the investigator, may interfere with the conduction of the Study, the evaluation of response, or with consent procedure.\n13. Pregnancy or breastfeeding, or intention of becoming pregnant during Study treatment or within 6 months after the final dose of paclitaxel, or 7 months after the final dose of trastuzumab, pertuzumab, or T-DM1, whichever occurs last.\n\n    Note: Women of childbearing potential must have a negative serum pregnancy test result within 7 days prior to initiation of Study treatment.\n14. Persons deprived of their liberty or under protective custody or guardianship.\n15. Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons.",{"count":425,"type":23},304,[89],"The primary goal of the DEFINITIVE trial is to demonstrate the effectiveness of the HER2DX diagnostic assay in enhancing the management of patients with early-stage HER2- positive breast cancer.\n\nPatients randomized to arm A will receive adjuvant treatment by physician´s choice, blinded to the diagnostic HER2DX test results. Patients randomized to Arm B will receive personalized treatment according to HER2DX results.",[228,93],"2026-02-19",{"date":431,"type":38},"2026-02-20",{"date":433,"type":38},"2024-10-11",{"date":435,"type":23},"2028-11",{"name":437,"class":45},"Fundacio Clinic Barcelona",29,{"id":440,"slug":441,"hasResults":12,"nctId":442,"briefTitle":443,"officialTitle":444,"acronym":445,"eligibilityCriteria":446,"healthyVolunteers":12,"sex":85,"minAge":19,"maxAge":4,"enrollmentInfo":447,"targetDuration":4,"studyType":24,"phases":449,"briefSummary":450,"conditions":451,"keywords":453,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":468,"lastUpdatePostDateStruct":469,"startDateStruct":471,"completionDateStruct":473,"leadSponsor":475,"locationsCount":46},"100598403","phase-2-evaluating-the-use-of-a-medication-switch-vs-guideline-directed-interventions-for-relieving-side-effects-of-aromatase-inhibitors-among-breast-cancer-patients-100598403","NCT07071038","Evaluating the Use of a Medication 'Switch' vs Guideline-directed Interventions for Relieving Side Effects of Aromatase Inhibitors Among Breast Cancer Patients","The 'SWIVEL' Study (Switch Vs Effects Relief): Effectiveness of a Medication 'Switch' vs Guideline-Directed Interventions for Relieving Side Effects of Aromatase Inhibitors Among Breast Cancer Patients","SWIVEL","Inclusion Criteria:\n\n* Histologic documentation of DCIS or invasive breast cancer by core needle or incisional biopsy.\n* The DCIS or invasive cancer must be estrogen receptor alpha (ER)-positive\n* The invasive cancer must be HER2-negative (IHC 0-1+, or with a FISH ratio of \\\u003C1.8 if IHC is 2+ or if IHC has not been done)\n* Clinical Stage I-III invasive breast cancer or DCIS\n* Patients for whom adjuvant treatment with one of the following would be clinically indicated: letrozole, anastrozole, exemestane\n* Patients who anticipate continuing with adjuvant endocrine therapy for a minimum of 2 years at the time of registration\n* Women over 18 years of age who are post-menopausal, defined as last menstrual period \\>2 years prior to registration, or \\>1 year prior to registration with FSH and estradiol in post-menopausal range.\n* Patients must meet the following clinical laboratory criteria:\n\n  * Absolute neutrophil count (ANC) \\>1,000\u002Fmm3 and platelet count \\> 75,000\u002Fmm3\n  * Total bilirubin \\\u003C1.5 x the upper limit of the normal range (ULN).\n  * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C 3 x ULN.\n* Ability to give informed consent.\n\nExclusion Criteria:\n\n* Prior endocrine therapy for any histologically-confirmed cancer or prevention of breast cancer in the last 10 years is not allowed.\n* Any other adjuvant therapy for breast cancer. Exception: Bisphosphonate or denosumab treatment for metabolic bone issues are allowed.\n* Patients who are prescribed tamoxifen as the first endocrine therapy rather than an aromatase inhibitor.\n* Women who are pregnant or lactating.\n* Prisoners.",{"count":448,"type":23},62,[26],"Researchers have learned that about 50% of women do not finish the standard 5-year breast cancer treatment with an aromatase inhibitor. An aromatase inhibitor is hormone therapy that lowers the chance of breast cancer coming back (recurring) after surgery by blocking an enzyme in fat tissue called aromatase; aromatase changes other hormones in the body to estrogen. Women who do not complete the standard 5-year treatment are at higher risk of their cancer coming back. The goal of this research is to prevent breast cancer from coming back after surgery by helping women to stay on treatment with aromatase inhibitors. Researchers believe the best path to help women to stay on treatment is to create a better way to manage (control) side effects.",[92,452,166],"Adjuvant Treatment",[454,455,456,457,458,459,460,461,462,463,464,465,466,467],"breast cancer surgery","aromatase inhibitor","aromatase side effects","hormone therapy","quality of life","adherence","early breast cancer","switching medications","hormonal therapy","letrozole","anastrozole","exemestane","tamoxifen","adjuvant therapy","2026-02-10",{"date":470,"type":38},"2026-02-12",{"date":472,"type":38},"2025-10-17",{"date":474,"type":23},"2027-08-05",{"name":476,"class":45},"Dartmouth-Hitchcock Medical Center",{"id":478,"slug":479,"hasResults":12,"nctId":480,"briefTitle":481,"officialTitle":482,"acronym":483,"eligibilityCriteria":484,"healthyVolunteers":12,"sex":85,"minAge":19,"maxAge":4,"enrollmentInfo":485,"targetDuration":4,"studyType":24,"phases":487,"briefSummary":488,"conditions":489,"keywords":490,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":495,"lastUpdatePostDateStruct":496,"startDateStruct":498,"completionDateStruct":500,"leadSponsor":502,"locationsCount":504},"100497159","phase-4-evaluating-omission-of-granulocyte-colony-stimulating-factors-in-breast-cancer-patients-receiving-paclitaxel-portion-of-dose-dense-adriamycin-cyclophosphamide-and-paclitaxel-chemotherapy-100497159","NCT05753618","Evaluating Omission of Granulocyte Colony-stimulating Factors in Breast Cancer Patients Receiving Paclitaxel Portion of Dose-dense Adriamycin-cyclophosphamide and Paclitaxel Chemotherapy","A Randomized Pragmatic Trial Evaluating Omission of Granulocyte Colony-stimulating Factors in Breast Cancer Patients Receiving Paclitaxel Portion of Dose-dense Adriamycin-cyclophosphamide and Paclitaxel Chemotherapy (REaCT-OGF)","REaCT-OGF","Inclusion Criteria:\n\n* Patients with early-stage or locally-advanced breast cancer receiving neoadjuvant or adjuvant DD-AC\u002FT chemotherapy requiring primary febrile neutropenia prophylaxis with G-CSF\n* Able to provide verbal consent\n* Able to complete questionnaires in English or French\n\nExclusion Criteria:\n\n* No access to pegfilgrastim or filgrastim prior to randomization\n* Metastatic cancer\n* Known hypersensitivity to filgrastim or pegfilgrastim or one of its components\n* Patients received prior cytotoxic chemotherapy within the last 5 years\n* Patients with uncontrolled inter-current illness that would limit compliance with study requirements or other significant diseases or disorders that, in the investigator's opinion, would exclude the subject from participating in the study",{"count":486,"type":23},242,[251],"The goal of this randomized, pragmatic clinical trial is to evaluate the omission of granulocyte colony-stimulating factors (G-CSF) in breast cancer patients receiving paclitaxel portion of dose-dense adriamycin-cyclophosphamide and paclitaxel (DD-AC\u002FT) chemotherapy. Participants will be randomized to either take G-CSF while on the paclitaxel portion of DD-AC\u002FT chemotherapy or to omit G-CSF while on the paclitaxel portion of DD-AC\u002FT chemotherapy.",[93],[491,492,493,494],"Filgrastim","Pegfilgrastim","Bone pain","Paclitaxel","2026-02-05",{"date":497,"type":38},"2026-02-09",{"date":499,"type":38},"2023-04-17",{"date":501,"type":23},"2026-10",{"name":503,"class":45},"Ottawa Hospital Research Institute",3,{"id":506,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":507,"targetDuration":4,"studyType":24,"phases":508,"briefSummary":27,"conditions":509,"keywords":4,"overallStatus":142,"whyStopped":4,"lastUpdateSubmitDate":510,"lastUpdatePostDateStruct":511,"startDateStruct":513,"completionDateStruct":515,"leadSponsor":516,"locationsCount":4},"100621091",{"count":22,"type":23},[26],[29,30,31,32,33],"2026-01-18",{"date":512,"type":38},"2026-01-26",{"date":514,"type":23},"2026-02-01",{"date":42,"type":23},{"name":44,"class":45},{"id":518,"slug":4,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":519,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":520,"targetDuration":4,"studyType":24,"phases":521,"briefSummary":58,"conditions":522,"keywords":523,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":510,"lastUpdatePostDateStruct":524,"startDateStruct":526,"completionDateStruct":527,"leadSponsor":528,"locationsCount":46},"100590706","Inclusion Criteria:\n\n* Female breast cancer patients aged ≥18 years and ≤75 years, either postmenopausal or premenopausal\u002Fperimenopausal;\n* Pathologically confirmed hormone receptor-positive (HR+), HER2-negative invasive breast cancer:\n\n  1. ER-positive and\u002For PR-positive defined as: ≥10% of tumor cells showing positive staining;\n  2. HER2-negative defined as: standard immunohistochemistry (IHC) result of 0\u002F1+; or IHC 2+ with negative in situ hybridization (ISH) (confirmed by the central pathology laboratory);\n* At least one evaluable lesion per RECIST 1.1, with clinical staging meeting:\n\n  1. T1c-3N0M0 with high-risk factors (Grade 3, or Grade 2 with Ki67 ≥20%);\n  2. Any TN+M0;\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;\n* Willing to participate in the study and voluntarily sign informed consent;\n* Agree to undergo ctDNA testing during treatment;\n* Adequate organ and bone marrow function defined as:\n\n  1. Absolute neutrophil count (ANC) ≥1,500\u002Fmm³ (1.5 × 10⁹\u002FL) (without granulocyte colony-stimulating factor \\[G-CSF\\] treatment within 14 days);\n  2. Platelet count (PLT) ≥100,000\u002Fmm³ (100 × 10⁹\u002FL) (without corrective therapy within 7 days);\n  3. Hemoglobin (Hb) ≥9 g\u002FdL (90 g\u002FL) (without corrective therapy within 7 days);\n  4. Serum creatinine ≤1.5× upper limit of normal (ULN) or creatinine clearance ≥60 mL\u002Fmin (without corrective therapy within 7 days);\n  5. Total bilirubin (TBIL) ≤1.5×ULN (without corrective therapy within 7 days);\n  6. Aspartate aminotransferase (AST\u002FSGOT) and alanine aminotransferase (ALT\u002FSGPT) ≤1.5×ULN (without corrective therapy within 7 days);\n  7. Cardiac function: left ventricular ejection fraction (LVEF) ≥55%; QTc interval corrected by Fridericia's formula (QTcF) \\\u003C470 msec on 12-lead ECG;\n* Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to randomization and agree to use non-hormonal contraception from informed consent signing until 2 months after the last treatment.\n\nExclusion Criteria:\n\n* HER2-positive breast cancer confirmed by current pathological diagnosis;\n* Inflammatory breast cancer;\n* Stage IV (metastatic) breast cancer;\n* Bilateral breast cancer;\n* Prior history of breast cancer (including ductal carcinoma in situ or invasive breast cancer);\n* Any prior antitumor therapy for the current breast cancer, including systemic therapies (endocrine, chemotherapy, immunotherapy, biological therapy) or local therapies (radiotherapy, vascular embolization, axillary lymph node biopsy);\n* Diagnosis of any malignancy within 5 years prior to randomization, except cured cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma of the skin;\n* History of severe pulmonary diseases (e.g., interstitial pneumonia);\n* HIV infection, acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA ≥500 IU\u002FmL), hepatitis C (HCV antibody-positive with HCV RNA above the lower limit of detection), or co-infection with HBV and HCV;\n* Within 6 months prior to randomization: myocardial infarction, severe\u002Funstable angina, NYHA Class ≥II heart failure, ≥Grade 2 persistent arrhythmia (per NCI CTCAE v5.0), atrial fibrillation of any grade, coronary\u002Fperipheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident (including transient ischemic attack), or symptomatic pulmonary embolism;\n* Severe active infection within 4 weeks prior to randomization (requiring intravenous antibiotics, antifungals, or antivirals) or unexplained fever \\>38.5°C during screening\u002Fbefore first dose;\n* Known allergy to any component of the study drugs;\n* Current participation in another interventional drug clinical study;\n* Pregnancy or lactation;\n* Refusal to comply with follow-up;\n* Other severe physical\u002Fmental illnesses or laboratory abnormalities that may increase study risk, interfere with results, or render the patient unsuitable per investigator judgment.",{"count":56,"type":23},[26],[29,30,31,32,33,60],[62,63,64,65,66,67,68,69,70,71,72],{"date":525,"type":38},"2026-01-21",{"date":75,"type":38},{"date":42,"type":23},{"name":44,"class":45},{"id":530,"slug":531,"hasResults":12,"nctId":532,"briefTitle":533,"officialTitle":534,"acronym":4,"eligibilityCriteria":535,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":536,"targetDuration":4,"studyType":24,"phases":538,"briefSummary":539,"conditions":540,"keywords":541,"overallStatus":142,"whyStopped":4,"lastUpdateSubmitDate":550,"lastUpdatePostDateStruct":551,"startDateStruct":553,"completionDateStruct":555,"leadSponsor":557,"locationsCount":46},"100611746","shaving-as-an-safe-alternative-to-frozen-section-analysis-100611746","NCT07244588","Shaving as an Safe Alternative to Frozen Section Analysis","Evaluation of Tumor Bed Cavity Shaving as an Oncologically Safe Alternative to Frozen Section Analysis in Breast-Conserving Surgery","Inclusion Criteria:\n\n* Female patients aged ≥18 years.\n* Diagnosed with unifocal, operable invasive breast carcinoma.\n* Suitable for breast-conserving surgery. Criteria:\n\nExclusion criteria:\n\n-Contraindication of Breast-Conserving Surgery.",{"count":537,"type":23},30,[89],"Evaluation of Tumor Bed Cavity Shaving as an Oncologically Safe Alternative to Frozen Section Analysis in Breast-Conserving Surgery and aim of study To assess the oncological safety and practicality of tumor bed cavity shaving also aims to evaluate its impact on operative time and overall cost.",[166],[542,543,544,545,546,547,548,549],"Breast cancer","Breast conserve surgery","low socioeconomic settings","Shaving","Margin status","Fresh frozen section","Operative time","Safe Alternative","2025-11-20",{"date":552,"type":38},"2025-11-24",{"date":554,"type":23},"2025-12",{"date":556,"type":23},"2026-12",{"name":558,"class":45},"Mark Ezzat Gerges",{"id":560,"slug":561,"hasResults":12,"nctId":562,"briefTitle":563,"officialTitle":564,"acronym":4,"eligibilityCriteria":565,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":566,"targetDuration":4,"studyType":24,"phases":568,"briefSummary":569,"conditions":570,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":572,"lastUpdatePostDateStruct":573,"startDateStruct":575,"completionDateStruct":577,"leadSponsor":579,"locationsCount":581},"100482218","phase-2-statins-for-reduction-of-cardiac-toxicity-in-patients-receiving-her2-targeted-100482218","NCT05559164","Statins for Reduction of Cardiac Toxicity in Patients Receiving HER2 Targeted","STACIE: Statins for Reduction of Cardiac Toxicity in Patients Receiving HER2 Targeted Therapy","Inclusion Criteria:\n\n* Histologically and\u002For cytologically confirmed diagnosis of Stage I-III female breast cancer (including inflammatory breast cancer)\n* Scheduled to receive neoadjuvant\u002Fadjuvant HER2 targeted therapy\n* Between ≥18 years of age\n* Female patients of childbearing potential must have a negative pregnancy test (serum or urine) prior to enrollment. Female patients must agree to use effective barrier contraception during the period of therapy\n* Baseline LVEF ≥ 50%\n* Prior cancers allowed if no evidence of disease in last 5 years\n* ECOG 0-2\n* No prior history of treatment with HER2 targeted therapy or anthracyclines based chemotherapy\n* Adequate bone marrow function:\n\nI. ANC ≥ 1000\u002FuL II. platelet count ≥ 100,000\u002FuL III. hemoglobin ≥ 9.0 g\u002FdL\n\n• Adequate hepatic function: I. Total bilirubin ≤ 1.5 X ULN II. AST (SGOT) ≤ 5 X ULN III. ALT (SGPT) ≤ 5 X ULN\n\n* Adequate renal function, Creatinine \\\u003C 1.5x institutional ULN or calculated creatinine clearance ≥ 50 mL\u002Fmin as estimated using the Cockcroft-Gault formula\n* Ability to understand the nature of this study protocol and give written informed consent\n* Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures\n\nExclusion Criteria:\n\n* Participants with stage IV breast cancer\n* Participants currently taking statins\n* Uncontrolled hypertension (systolic blood pressure \\>190 mm Hg or diastolic blood pressure \\>100 mm Hg)\n* No active liver disease\n* Current use of CYP 3A4 inhibitors\n* Any condition including the presence of laboratory abnormalities, which, in the opinion of the investigator places the subject at unacceptable risk if he\u002Fshe were to participate in the study\n* Life expectancy \\\u003C 12 weeks\n* Pregnancy (positive pregnancy test) or lactation\n* Pre-existing sensory neuropathy \\> grade one\n* Has significant cardiovascular disease, such as:\n\nLVEF \\\u003C 50% at baseline as assessed by ECHO (preferred) i) Class III or Class IV myocardial disease as described by the New York Heart Association ii) Recent history (within 6 months prior to enrollment) of myocardial infarction; or iii) Symptomatic arrhythmia at the time of randomization\n\n* Major surgery without complete recovery in the past four weeks prior to screening\n* Concurrent active infection\n* Participant with uncontrolled and\u002F or active infection with HIV, Hepatitis B or Hepatitis C\n* Participant who has a history of allergy or hypersensitivity to any of the study drugs\n* Participant with a history of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, interstitial pulmonary fibrosis, pulmonary hypersensitivity pneumonitis\n* Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study",{"count":567,"type":23},60,[26],"This study proposes that the addition of statins reduces the treatment delays or early discontinuations secondary to cardiotoxicity in patients with Stage I-III HER2 positive breast being treated with anti-HER2 therapy.",[571,93],"Cardiac Toxicity","2025-11-13",{"date":574,"type":38},"2025-11-14",{"date":576,"type":38},"2022-09-19",{"date":578,"type":23},"2027-03-01",{"name":580,"class":45},"Rutgers, The State University of New Jersey",10,{"id":583,"slug":584,"hasResults":12,"nctId":585,"briefTitle":586,"officialTitle":587,"acronym":4,"eligibilityCriteria":588,"healthyVolunteers":12,"sex":85,"minAge":19,"maxAge":4,"enrollmentInfo":589,"targetDuration":4,"studyType":24,"phases":591,"briefSummary":592,"conditions":593,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":599,"lastUpdatePostDateStruct":600,"startDateStruct":602,"completionDateStruct":604,"leadSponsor":606,"locationsCount":608},"100405007","phase-2-trastuzumab-deruxtecan-alone-or-in-combination-with-anastrozole-for-the-treatment-of-early-stage-her2-low-hormone-receptor-positive-breast-cancer-100405007","NCT04553770","Trastuzumab Deruxtecan Alone or in Combination With Anastrozole for the Treatment of Early Stage HER2 Low, Hormone Receptor Positive Breast Cancer","A Phase II, Multicenter, Open-Label Trial to Evaluate the Safety and Efficacy of Trastuzumab Deruxtecan (DS-8201a) With or Without Anastrozole for HER2 Low Hormone Receptor Positive (HR+) Breast Cancer in the Neoadjuvant Setting","Inclusion Criteria:\n\n* Previously untreated operable invasive carcinoma of the breast greater than 2.0 cm (cT2) in size based on physical exam or imaging. Patients with clinical node negative disease or clinical node (cN1\u002FcN2) positive are allowed provided they are deemed to have operable disease at study entry\n* Participants with clinically involved lymph nodes should not have radiological evidence of distant disease per standard of care staging prior to patient informed consent form (PICF) signature\n* In the United States\n* Tumor is HER2-low by immunohistochemistry (IHC), defined as 1+ or 2+, confirmed by central testing (central testing results not required for enrollment, unless no local results available). If HER2 is 2+ by IHC, fluorescence in situ hybridization (FISH) must be performed (per standard of care) and the FISH result must be HER2 non-amplified per 2018 American Society of Clinical Oncology College of American Pathologists (ASCO CAP) guidelines\n* Tumor is HR positive (HR+) per ASCO CAP guidelines with known estrogen and progesterone receptor status, locally defined\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Normal cardiac function (left ventricular ejection fraction \\[LVEF\\] \\>= 50%) based on echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 28 days before randomization\u002Fenrollment\n* Platelet count \\>= 100 000\u002Fmm\\^3 (Platelet transfusion is not allowed within 1 week prior to screening assessment) (within 14 days before randomization\u002Fenrollment)\n* Hemoglobin \\>= 9.0 g\u002FdL (red blood cell transfusion is not allowed within 1 week prior to screening assessment) (within 14 days before randomization\u002Fenrollment)\n* Absolute neutrophil count (ANC) \\>=1500\u002Fmm\\^3 (Granulocyte colony-stimulating factor (G-CSF) administration is not allowed within 1 week prior to screening assessment) (within 14 days before randomization\u002Fenrollment)\n* Creatinine clearance \\>= 30 mL\u002Fmin as calculated using the Cockcroft-Gault equation or serum creatinine =\\\u003C 1.5 x upper limit of normal (ULN) (within 14 days before randomization\u002Fenrollment)\n* Alanine aminotransferase (ALT), aspartate aminotransferase (AST) =\\\u003C 3 x ULN (within 14 days before randomization\u002Fenrollment)\n* Total bilirubin =\\\u003C 1.5 x ULN (within 14 days of randomization\u002Fenrollment). Participants with Gilbert's syndrome with a total bilirubin =\\\u003C 2.0 times ULN and direct bilirubin within normal limits are permitted\n* Serum albumin \\>= 2.5 g\u002FdL (within 14 days before randomization\u002Fenrollment)\n* International normalized ratio (INR)\u002Fprothrombin time (PT) and activated partial thromboplastin time (aPTT) =\\\u003C 1.5 x ULN (within 14 days before randomization\u002Fenrollment)\n* Has adequate treatment washout period before randomization\u002Fenrollment, defined as:\n\n  * Major surgery \\>= 4 weeks\n  * Chloroquine\u002Fhydroxychloroquine \\> 14 days\n* Negative pregnancy test (serum) for women of child bearing potential (CBP):\n\n  * Women are considered of CBP unless: they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (i.e. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy, or tubal ligation at least six weeks prior to randomization. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment she is considered not of CBP\n* Male and female participants of reproductive\u002Fchildbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least 7 months for females and 4 months for males after the last dose of study drug. Highly effective contraception methods include:\n\n  * Total abstinence (when this is in line with the preferred and usual lifestyle of the patient). Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\n  * Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy or tubal ligation at least 6 weeks before taking trial treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\n  * Male partner sterilization (at least 6 months prior to randomization). For female patients on the trial the vasectomized male partner should be the sole partner for that patient. If vasectomy of the male partner is the highly effective method of contraception chosen, the success of the vasectomy should be medically confirmed according to local practice\n  * Placement of an intrauterine device (IUD)\n* Male participants must not freeze or donate sperm starting at screening and throughout the study period, and at least 4 months after the final study drug administration. Preservation of sperm should be considered prior to enrollment in this study\n* Female participants must not donate, or retrieve for their own use, ova from the time of screening and throughout the study treatment period, and for at least 7 months after the final study drug administration\n* Estradiol level must be in post-menopausal range per local lab interpretation prior to baseline biopsy\n\n  * Postmenopausal status is defined as:\n\n    * Patient underwent bilateral oophorectomy, or\n    * Age \\>= 60 years, or\n    * Age \\\u003C 60 years and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifene or ovarian suppression) and follicle-stimulating hormone (FSH) and plasma estradiol are in the postmenopausal ranges per local normal ranges\n  * Note: for women with therapy-induced amenorrhea, serial measurements of FSH and\u002For estradiol per local clinical guidelines are required for determination of postmenopausal status. All women who do not meet the criteria for postmenopausal status are considered premenopausal for the purpose of this trial\n* Pre- or peri-menopausal and amenable to being treated with ovarian function suppression drugs (goserelin, leuprolide, or triptorelin) per standard of care. Patients must have started treatment with ovarian function suppression at least 28 days prior to first dose of study treatment\n\nExclusion Criteria:\n\n* Recurrent or metastatic breast cancer\n* Bilateral breast cancer (multifocal or multicentric breast cancer is allowed provided that all biopsied lesions are HER2 1+ or 2+, not FISH amplified and are HR positive per ASCO guidelines)\n* Inflammatory breast cancer\n* Prior systemic therapy for invasive cancer\n\n  * Prior tamoxifen for history of ductal breast carcinoma in situ (DCIS) allowed, but no prior aromatase inhibitor, no prior chemotherapy and no prior HER2-targeted therapy\n* Prior ipsilateral chest wall radiation\n* Major surgery \\\u003C 4 weeks prior to enrollment\n* Medical history of myocardial infarction within 6 months before randomization\u002Fenrollment, symptomatic congestive heart failure (CHF) (New York Heart Association Class II to IV), troponin levels consistent with myocardial infarction as defined according to the manufacturer 28 days prior to randomization\n* Unable to swallow oral medications\n* Is pregnant or lactating, or planning to become pregnant\n* Corrected QT interval prolongation to \\> 470 ms (females) or \\> 450 ms (males) based on average of the screening triplicate 12-lead electrocardiogram\n* Known hypercoaguable disorder requiring use of anticoagulant\n* Significant gastrointestinal disorders limiting absorption or tolerance of oral medications (for example, history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline grade 2 or higher diarrhea)\n* History of (non-infectious) interstitial lung disease (ILD)\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening\n* Has multiple primary malignancies within 3 years, except:\n\n  * Adequately resected non-melanoma skin cancer\n  * Curatively treated non breast in-situ disease, and other solid non-breast tumors curatively treated are allowed if \\> 3 years from diagnosis and no evidence of recurrence in that time\n  * Prior history of DCIS is allowed as long as patient has not received an aromatase inhibitor, has not received ipsilateral breast\u002Fchest radiation\n  * Prior history of contralateral invasive breast cancer (diagnosed by biopsy \\> 2 years prior to current diagnosis) is allowed provided patient has not received prior aromatase inhibitor, CDK4\u002F6 inhibitor (CDK4\u002F6i), HER2-targeted therapy or chemotherapy and has not experienced any recurrence and has no evidence of recurrence (based on standard clinical evaluation)\n* Other concurrent anti-cancer therapy. Note: ovarian function suppression drugs (goserelin, leuprolide, or triptorelin) and\u002For bone modifying agents (bisphosphonates, denosumab) do not count as anti-cancer therapy for this criteria. If taking bisphosphonates or denosumab, must have been on these agents prior to signing consent\n* Has substance abuse or any other medical conditions such as clinically significant cardiac or psychological conditions, that may, in the opinion of the investigator, interfere with the subject's participation in the clinical study or evaluation of the clinical study results\n* Has known human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA). Subjects should be tested for HIV prior to randomization\u002Fenrollment if required by local regulations or Institutional Review Board (IRB)\u002Fethics committee (EC)\n* Have personal history within the last 12 months of any of the following conditions: syncope of cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest\n* Have received an autologous or allogeneic stem-cell transplant\n* Has active systemic bacterial infection (requiring intravenous \\[IV\\] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C \\[for example, hepatitis B surface antigen positive\\]). Screening is not required for enrollment\n* Concurrent treatment with ovarian hormonal replacement therapy. Prior treatment must be stopped prior to first baseline biopsy\n* Has history of severe hypersensitivity reactions to other monoclonal antibodies and\u002For to either the drug substances or inactive ingredients in the drug product\n* Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (i.e. pulmonary emboli within three months of the study enrollment, severe asthma, severe chronic obstructive pulmonary disease \\[COPD\\], restrictive lung disease, pleural effusion etc.), and any autoimmune, connective tissue or inflammatory disorders with pulmonary involvement (i.e. rheumatoid arthritis, Sjogren's, sarcoidosis etc.), or prior pneumonectomy\n* Life expectancy \\\u003C 3 months",{"count":590,"type":23},88,[26],"This phase II trial investigates how well trastuzumab deruxtecan works alone or in combination with anastrozole in treating patients with HER2 low, hormone receptor positive breast cancer. Trastuzumab deruxtecan is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug called deruxtecan. Trastuzumab attaches to HER2 expressed at low levels on cancer cells in a targeted way and delivers deruxtecan to kill them. Anastrozole works by decreasing estrogen production and suppressing the growth of tumors that need estrogen to grow. This study is evaluating how effective trastuzumab deruxtecan is at treating hormone receptor positive cancer cells that have low levels of HER2 expressed on them when given alone or in combination with anastrozole.",[93,141,594,595,596,597,598],"Invasive Breast Cancer","Stage II Breast Cancer","Stage IIA Breast Cancer","Stage IIB Breast Cancer","Stage III Breast Cancer","2025-11-06",{"date":601,"type":38},"2025-11-10",{"date":603,"type":38},"2020-10-09",{"date":605,"type":23},"2026-12-31",{"name":607,"class":45},"Jonsson Comprehensive Cancer Center",9,{"id":610,"slug":611,"hasResults":12,"nctId":612,"briefTitle":613,"officialTitle":614,"acronym":615,"eligibilityCriteria":616,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":617,"targetDuration":4,"studyType":24,"phases":619,"briefSummary":620,"conditions":621,"keywords":622,"overallStatus":142,"whyStopped":4,"lastUpdateSubmitDate":626,"lastUpdatePostDateStruct":627,"startDateStruct":629,"completionDateStruct":631,"leadSponsor":633,"locationsCount":326},"100609498","impact-of-exercise-on-quality-of-life-of-ebc-patients-on-treatment-with-adjuvant-ai-with-or-without-cdk46-inhibitors-100609498","NCT07215364","Impact of Exercise on Quality of Life of EBC Patients on Treatment With Adjuvant AI With or Without CDK4\u002F6 Inhibitors","Impact of EXercise on Quality of Life of Early Breast Cancer Patients on Treatment With Adjuvant Aromatase Inhibitors With or Without CDK4\u002F6 Inhibitors. \"The EXAI Study\"","EX-AI","Inclusion Criteria:\n\n1. Written informed consent document (ICD) prior to any specific study procedures, showing patience, willingness and ability to comply with the physical activity program in the experimental group, and scheduled visits and study procedures in both groups.\n2. Patients ≥18 years of age at signing of ICD.\n3. Documented histologically confirmed HR+\u002FHER2- invasive EBC, adequately treated according to standard clinical practice and with absence of any evidence of disease (loco-regional or metastatic at distance).\n\n   HR and HER2 assessments are performed under institutional guidelines.\n   * HR testing should utilize an assay consistent with the most recent American Society of Clinical Oncology (ASCO)\u002F College of American Pathologists (CAP) Guidelines.\n   * HER2 negativity is determined as immunohistochemistry (IHC) score 0\u002F1+ or negative by in situ hybridization (ISH) according to the recommendations of the most recent ASCO\u002FCAP Guidelines.\n4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2.\n5. Pre-, peri-, and post-menopausal women (as determined by the investigator and according to the institutional guidelines) that have already received between 10 and 18 weeks of an AI (with or without a LHRHa) before the randomization in the study and administered according to local guidelines.\n\n   Note: Patients that are candidate to receive an adjuvant CDK4\u002F6i will only be eligible if the CDK4\u002F6i was initiated at least 6 weeks before the randomization in the study and administered according to local guidelines.\n6. Patients must have undergone adequate (definitive) loco-regional therapy (surgery with or without radiation therapy), with or without neo-\u002Fadjuvant systemic CT.\n7. Patients must have an adequate organ and bone marrow function according to the standard clinical practice and institutional guidelines.\n8. Patients must be able and willing to fill out repeated questionnaires on QoL, pain and fatigue, as well as to adhere to the physical activity program.\n9. Fluent Spanish language skills for the complete comprehension of the questionnaires.\n10. With the consent of the investigator for participation in physical training and considering the medical history of the patient.\n\nExclusion Criteria:\n\n1. Patients have received less than 10 weeks or more than 18 weeks of an AI (with or without a LHRHa) before the randomization in the study.\n2. Patients that are candidate to receive an adjuvant CDK4\u002F6i initiated the treatment less than 6 weeks before the randomization in the study.\n3. Patients have musculoskeletal injuries.\n4. Patients have known significant heart disease (myocardial infarction, unstable angina, congestive heart failure, cardiomyopathy, etc.).\n5. Patients with weight over 150kg.\n6. Patients have any type of illness or mental condition that prevents or compromises the well-being of the patient or compliance with the procedures.\n7. Patients have any cardiovascular contraindication to physical training by the investigator.\n8. Patients have been performing supervised training, either aerobic and\u002For resistance training (at a gym \\[group or individual classes\\] or in a specific sport), at least 2 days per week in the past 6 months.\n9. No access and\u002For unable to manage the website and other digital tools (i.e. applications) for training sessions.",{"count":618,"type":23},74,[89],"This is a national clinical trial (Spain), conducted in approximately 5 sites, where patients who agree to participate will be included in one of two exercise program groups: the experimental group (a combined resistance and aerobic exercise program) and the control group.\n\nThe study will begin with a pilot phase involving approximately 74 patients.\n\nApproximately 37 patients in the experimental group will follow a 6-month training program consisting of exercise sessions three alternate days per week (combining resistance and aerobic exercise).\n\nApproximately 37 patients in the control group will receive standard medical care. These patients will be provided with international exercise guidelines for cancer patients.\n\nPatients will continue with their assigned physical activity intervention until the maximum number of months for the intervention, unacceptable toxicity, discontinuation of hormone therapy, or withdrawal of consent-whichever occurs first.",[93],[623,624,625],"early-stage breast cancer (EBC)","HR-positive","HER2-negative","2025-10-01",{"date":628,"type":38},"2025-10-10",{"date":630,"type":23},"2026-03",{"date":632,"type":23},"2029-03",{"name":634,"class":45},"Spanish Breast Cancer Research Group",{"id":636,"slug":637,"hasResults":12,"nctId":638,"briefTitle":639,"officialTitle":640,"acronym":4,"eligibilityCriteria":641,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":219,"enrollmentInfo":642,"targetDuration":4,"studyType":24,"phases":644,"briefSummary":645,"conditions":646,"keywords":650,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":653,"lastUpdatePostDateStruct":654,"startDateStruct":656,"completionDateStruct":658,"leadSponsor":660,"locationsCount":46},"100497697","phase-3-adjuvant-trastuzumab-plus-neratinib-in-hormone-receptor-positivehuman-epidermal-growth-factor-receptor-2-positive-breast-cancer-after-neoadjuvant-trastuzumab-plus-pertuzumab-100497697","NCT05760612","Adjuvant Trastuzumab Plus Neratinib in Hormone Receptor-Positive\u002FHuman Epidermal Growth Factor Receptor 2-Positive Breast Cancer After Neoadjuvant Trastuzumab Plus Pertuzumab","A Randomized, Open-Label, Phase III Trial Comparing Adjuvant Trastuzumab Plus Neratinib Versus Trastuzumab Plus Pertuzumab in Hormone Receptor-Positive\u002FHuman Epidermal Growth Factor Receptor 2-Positive Breast Cancer With Residual Cancer Burden 0\u002FI After Neoadjuvant Trastuzumab Plus Pertuzumab","Inclusion Criteria:\n\n1. Female patients aged 18-70 years;\n2. Eastern Cooperative Oncology Group performance status of 0 or 1;\n3. Clinical stage at initial diagnosis (per the 8th edition of the American Joint Committee on Cancer Staging Manual): cT1-4\u002FN1-3\u002FM0 (cT1mi\u002FN0 or cT1a-b\u002FN0 are eligible), meeting the criteria for neoadjuvant therapy as per NCCN 2022 guidelines;\n4. Histologically confirmed hormone receptor-positive (estrogen receptor ≥1% and\u002For progesterone receptor ≥1%) and HER2-positive (immunohistochemistry 3+ or fluorescence in situ hybridization-positive) invasive breast cancer;\n5. Completion of ≥4 cycles of neoadjuvant therapy with trastuzumab and pertuzumab, without recurrence or metastatic disease prior to adjuvant treatment; residual cancer burden class 0 or I after neoadjuvant therapy; time from initial surgery to randomization ≤12 weeks;\n6. Adequate organ function within 2 weeks prior to screening (without transfusion or use of growth factors):\n\n   * Absolute neutrophil count ≥1.5 × 10⁹\u002FL;\n   * Platelet count ≥90 × 10⁹\u002FL;\n   * Hemoglobin ≥90 g\u002FL;\n   * Total bilirubin ≤1.5 × upper limit of normal (ULN);\n   * Alanine aminotransferase and aspartate aminotransferase ≤1.5 × ULN;\n7. Post-neoadjuvant therapy echocardiography showing left ventricular ejection fraction (LVEF) ≥50% during screening, with an absolute decrease of ≤15% compared to pre-chemotherapy values; if no pre-chemotherapy LVEF assessment is available, LVEF must be ≥55% during screening;\n8. Life expectancy ≥6 months;\n9. For premenopausal or non-sterilized female patients: agreement to abstain from sexual activity or use effective non-hormonal contraception during study treatment and for 8 weeks after the last dose;\n10. Willingness to participate voluntarily, provide signed informed consent, demonstrate good compliance, and cooperate with follow-up.\n\nExclusion Criteria:\n\n1. History of local or regional breast cancer recurrence;\n2. Clinical stage IV (metastatic) breast cancer;\n3. Bilateral breast cancer;\n4. History of other malignant tumors within the past 5 years, except for curatively treated cervical carcinoma in situ, basal cell carcinoma, or cutaneous squamous cell carcinoma;\n5. Prior treatment with pyrotinib, lapatinib, neratinib, or other tyrosine kinase inhibitors; trastuzumab emtansine; or any antitumor biological or immunotherapy;\n6. Concurrent participation in another clinical trial involving antitumor therapy, including endocrine therapy, bisphosphonate therapy, or immunotherapy;\n7. Significant cardiac disease, including:\n\n   * Heart failure or systolic dysfunction (LVEF \\\u003C 50%);\n   * Poorly controlled arrhythmias (e.g., atrial tachycardia, significant ventricular arrhythmia, or high-grade atrioventricular block);\n   * Angina requiring antianginal medication;\n   * Clinically significant valvular heart disease;\n   * Electrocardiographic evidence of transmural myocardial infarction;\n   * Poorly controlled hypertension (systolic blood pressure \\> 180 mmHg and\u002For diastolic blood pressure \\> 100 mmHg) despite medication;\n8. Impaired drug absorption due to dysphagia, intestinal obstruction, or other gastrointestinal disorders;\n9. History of neurological or psychiatric conditions that may compromise compliance or informed consent;\n10. Chronic gastrointestinal disorders with predominant diarrhea;\n11. Known hypersensitivity to any study drug components; history of immunodeficiency (e.g., HIV positivity, congenital or acquired immunodeficiency disorder), or prior organ transplantation;\n12. Pregnancy, lactation, or positive pregnancy test at baseline in women of childbearing potential;\n13. Severe comorbidities that may interfere with treatment, including active infections (e.g., hepatitis B, hepatitis C, tuberculosis, syphilis) or any other condition deemed by the investigator to render the patient unsuitable for trial participation.",{"count":643,"type":23},300,[402],"Neratinib is an irreversible pan-HER tyrosine kinase inhibitor (TKI). Currently, no studies have investigated the use of macromolecular anti-HER2 agents combined with TKIs for the treatment of non-pCR HER2-positive breast cancer following neoadjuvant therapy. Furthermore, there are no prospective randomized controlled trials comparing trastuzumab plus pertuzumab versus trastuzumab plus TKIs in HER2-positive breast cancer patients with residual cancer burden class (RCB) I or II after neoadjuvant trastuzumab and pertuzumab. Therefore, this study aimed to evaluate the efficacy and safety of adjuvant trastuzumab plus neratinib in patients with hormone receptor-positive\u002FHER2-positive breast cancer and RCB 0\u002FI following neoadjuvant trastuzumab and pertuzumab therapy.",[93,228,647,648,649],"Adjuvant Treatment After Trastuzumab","RCB Classification 1-2","Neratini",[651,652,467],"Hormone receptor positive HER2 positive breast cancer","targeted therapy","2025-09-21",{"date":655,"type":38},"2025-09-25",{"date":657,"type":38},"2023-03-14",{"date":659,"type":23},"2028-11-01",{"name":661,"class":45},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University",{"id":663,"slug":664,"hasResults":12,"nctId":665,"briefTitle":666,"officialTitle":667,"acronym":668,"eligibilityCriteria":669,"healthyVolunteers":12,"sex":18,"minAge":369,"maxAge":157,"enrollmentInfo":670,"targetDuration":4,"studyType":24,"phases":672,"briefSummary":673,"conditions":674,"keywords":675,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":679,"lastUpdatePostDateStruct":680,"startDateStruct":682,"completionDateStruct":684,"leadSponsor":686,"locationsCount":504},"100512793","breast-cancer-exercise-intervention-study-100512793","NCT05957068","Breast Cancer Exercise Intervention Study","Breast Cancer Exercise Intervention Study (BREXINT)","BREXINT","Inclusion Criteria:\n\n* Patients with histologically or cytologically proven stage 1, 2, or 3 breast cancer\n* Patients who have undergone curative breast surgery\n* Patients who have received (neo)adjuvant chemotherapy (if given) and\u002For radiotherapy (if given)\n* Females aged 21 years and older\n* ≤ 8 weeks from breast surgery, or the last adjuvant chemotherapy or radiotherapy session, whichever is latest.\n\nExclusion Criteria:\n\n* Cardiovascular, respiratory, musculoskeletal problems that preclude moderate physical activity.\n* Major medical problems that are deemed by the investigator to be unsuitable for enrollment.",{"count":671,"type":23},2156,[89],"This is a 24-week exercise programme consisting of aerobic exercise and muscle strength training, 3 sessions per week. The first 9 sessions are supervised by physiotherapists in person, followed by 63 sessions monitored remotely (video) or supervised by trainers at ActiveSG (Sport Singapore) gyms.",[93,231],[668,676,677,678],"Muscular Strength","Cardiorespiratory Fitness","Quality of Life","2025-09-03",{"date":681,"type":38},"2025-09-05",{"date":683,"type":38},"2023-07-01",{"date":685,"type":23},"2033-05-31",{"name":687,"class":45},"National Cancer Centre, Singapore"]