[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"breast-cancer-early-stage-breast-cancer-stage-1-3\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:breast-cancer-early-stage-breast-cancer-stage-1-3":34},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,38,0,25,[9,60,82,123,155,183,208,238,267,298,331,367,389,418,431,459,486,514,540,563,587,610,632,659,686],{"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":35,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":59},"100053782","phase-2-ctdna-guided-de-escalation-of-adjuvant-chemotherapy-with-dalpiciclib-in-hr-positiveher2-negative-breast-cancer-100053782",false,"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.","FEMALE","18 Years","75 Years",{"count":22,"type":23},393,"ESTIMATED","INTERVENTIONAL",[26],"PHASE2","* 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.",[29,30,31,32,33,34],"Hormone Receptor-Positive Breast Cancer","High-risk Breast Cancer","Early-Stage Breast Cancer","HER2-negative Breast Cancer","ctDNA Monitoring","Breast Cancer Early Stage Breast Cancer (Stage 1-3)",[36,37,38,39,40,41,42,43,44,45,46],"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","RECRUITING","2026-07-10",{"date":50,"type":51},"2026-07-13","ACTUAL",{"date":53,"type":51},"2025-08-01",{"date":55,"type":23},"2029-12-31",{"name":57,"class":58},"Peking University People's Hospital","OTHER",1,{"id":61,"slug":62,"hasResults":12,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":4,"eligibilityCriteria":66,"healthyVolunteers":12,"sex":18,"minAge":67,"maxAge":4,"enrollmentInfo":68,"targetDuration":4,"studyType":24,"phases":70,"briefSummary":72,"conditions":73,"keywords":4,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":80,"locationsCount":59},"100584156","single-vs-hypofractionated-irradiation-for-timely-access-to-partial-breast-radiotherapy-100584156","NCT06885671","Single vs Hypofractionated Irradiation For Timely Access to Partial Breast Radiotherapy","Phase II Single vs Hypofractionated Irradiation For Timely Access to Partial Breast Radiotherapy: SHIFT-PB","Inclusion Criteria:\n\n* Female participants age 40 or older\n* Able to provide informed consent\n* pTis-2 pN0 cM0 breast cancer, with tumor size \\\u003C3 cm as per provincial guidelines\n* Able to complete electronic or paper entry of participant reported outcomes independently or with assistance from caregiver\u002Ffamily\u002Ffriend\u002Fresearch staff\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2\n* A history and physical (clinical breast) examination, including ECOG performance status, performed within 8 weeks prior to enrollment.\n* Participant is judged able to:\n\n  * Maintain a stable position during therapy\n  * Tolerate immobilization device(s) that may be required to deliver PBI safely\n* Negative pregnancy test for People of Child-Bearing Potential (POCBP) within 4 weeks of RT start date\n\nExclusion Criteria:\n\n* History of non-breast malignancies except adequately treated non-melanoma skin cancers, in situ cancers treated by local excision or other cancers curatively treated with no evidence of disease for ≥ 5 years.\n* Uncontrolled concurrent malignant cancer\n* Seroma not visible\n* Ipsilateral implanted cardiac device\n* Prior radiotherapy requiring summation for planning.\n* Requirement for a radiation boost (as determined by the treating investigator)\n* Positive surgical margins\n* Surgical cavities lacking clear delineation (surgical clips are not required but may assist in target delineation)\n* Known germline BRCA1\u002F2 mutation.\n* Serious medical comorbidities precluding radiotherapy (e.g., connective tissue disorders such as lupus or scleroderma)\n* Pregnant or breastfeeding","40 Years",{"count":69,"type":23},60,[71],"NA","Partial Breast Irradiation (PBI) is a targeted radiation approach commonly administered post-lumpectomy, specifically targeting the tumour bed. This targeted therapy reduces the exposure to other nearby tissues such as lungs, heart, and chest wall. However, traditional PBI treatment involves lengthy multiple fraction courses which presents a burden to patients from rural and remote communities, who must travel long distances to receive high quality cancer care. The purpose of this study is to compare single fraction (SF) PBI vs. multiple fraction (MF) PBI.",[34],"2026-06-18",{"date":76,"type":51},"2026-06-23",{"date":78,"type":23},"2026-06-08",{"date":55,"type":23},{"name":81,"class":58},"British Columbia Cancer Agency",{"id":83,"slug":84,"hasResults":12,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":12,"sex":90,"minAge":19,"maxAge":91,"enrollmentInfo":92,"targetDuration":4,"studyType":24,"phases":94,"briefSummary":95,"conditions":96,"keywords":103,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":59},"100587602","judicious-surveillance-for-trastuzumab-induced-cardiotoxicity-in-the-first-year-100587602","NCT06930521","JUdicious Surveillance for Trastuzumab Induced Cardiotoxicity in the First Year","JUdicious Surveillance for Trastuzumab Induced Cardiotoxicity in the First Year (JUSTIFY): a Randomized Controlled Trial","JUSTIFY","Inclusion Criteria:\n\n1. Stage 1-3 breast cancer (BC).\n2. Age 18-79 years.\n3. HER-2 positive BC with planned HER2 targeted therapy (HER2TT) for curative intent.\n\nExclusion Criteria:\n\n1. Distant metastases detected clinically, radiographically, or histologically\n2. Baseline echocardiogram images of insufficient quality for a quantitative assessment of left ventricular ejection fraction (LVEF)\n3. Pre-existing cardiovascular disease, defined as:\n\n   1. Prior myocardial infarction (even if LVEF has normalized)\n   2. Prior heart failure (HF, including patients with preserved ejection fraction and normalized LVEF)\n   3. Baseline LVEF \\\u003C55%\n   4. Atrial fibrillation\n   5. Greater than moderate valvular disease (i.e., severe, or moderate-severe)\n4. Cumulative anthracycline exposure ≥250mg\u002Fm2 before starting HER2TT\n5. New York Heart Association Functional Class II, III or IV, or Eastern Cooperative Oncology Group score \\>2\\*\n6. Symptoms potentially due to serious cardiac disease as per investigator's judgement\\* \\*Exclusion criterion adopted as they make clinical assessment less reliable to detect emergent HF.","ALL","79 Years",{"count":93,"type":23},300,[71],"This study focuses on male and female patients being treated for breast cancer that is positive for the HER2 receptor which requires special treatments targeting that receptor. The problem is that these treatments, while effective for the cancer, can sometimes harm the heart. Because of this, patients have to undergo heart tests every three months during treatment, even if they have no history of heart disease or feel fine.\n\nThe guidelines for these regular heart tests were established decades ago when these treatments were first introduced, but research shows that most of these tests don't actually change the treatment plan. This suggests that many patients are going through unnecessary tests, which can cause stress, delay treatments, and increase healthcare costs.\n\nTo address this, the researchers propose a new study with 300 patients with HER2 positive breast cancer to test a more personalized approach to cardiac surveillance. Participants will be classified based on their risk of heart problems: low or intermediate. Instead of testing every patient every three months, those in the intermediate group will be tested every 4 months, and those in the low-risk group will be tested every 6 months. The researchers will compare this new approach to the current system to see if fewer tests are just as safe and effective.\n\nThe researchers will measure heart health, how well cancer treatments are completed, and how patients feel about having fewer tests. If this new approach works, it could save money and reduce the burden on female patients without risking their health.",[97,98,34,99,100,101,102],"Cardiovascular Health","Breast Cancer","Cardio-oncology","Circulatory and Respiratory Health","Clinical and Translational Cardiovascular Sciences","Health Services and Systems - Healthcare Effectiveness &Amp; Outcomes",[104,105,106,107,108,109,110,111,112,113],"Trastuzumab","Cardiac imaging","Her-2 positive breast cancer","Echocardiography","Cardiotoxicity","Left ventricular ejection fraction","Heart failure","Randomized controlled trial","Nuclear imaging","Non-inferiority","2026-06-11",{"date":116,"type":51},"2026-06-15",{"date":118,"type":51},"2026-04-22",{"date":120,"type":23},"2033-06",{"name":122,"class":58},"Women's College Hospital",{"id":124,"slug":125,"hasResults":12,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":12,"sex":90,"minAge":131,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":134,"phases":4,"briefSummary":135,"conditions":136,"keywords":139,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":154},"100613958","aspects-of-adjuvant-cdk46-inhibitors-in-older-breast-cancer-patients---focusing-on-geriatric-screening-100613958","NCT07273357","Aspects of Adjuvant CDK4\u002F6 Inhibitors in Older Breast Cancer Patients - Focusing on Geriatric Screening","Follow-Up After adjuvanT CDK4\u002F6i Use in oldeR brEast Cancer Patients - Aspects on Geriatric Screening, Toxicities, and Quality of Life (FUTURE)","FUTURE","Inclusion Criteria:\n\n* ≥70 years old\n* Female\u002Fmale\n* Completed surgery (primary or after neoadjuvant therapy)\n* Starting adjuvant CDK4\u002F6i and endocrine therapy\n* Cognitive performance to be able answer questionaries\n* No language difficulties\n\nExclusion Criteria:\n\n* Impaired cognitive function not able to understand the study intention or perform questionaries\n* Declining adjuvant CDK4\u002F6i","70 Years",{"count":133,"type":23},200,"OBSERVATIONAL","Older breast cancer patients should not be categorically excluded from adjuvant therapies, including the recommended CDK4\u002F6 inhibitors (CDK4\u002F6i) administered in combination with endocrine therapy. Nevertheless, this population frequently presents with comorbidities that may increase susceptibility to treatment-related toxicities, including impacts on quality of life, which must be carefully considered when selecting therapeutic regimens. Given the limited representation of older patients in the clinical trials behind the recommendations for adjuvant CDK4\u002F6i therapy, coupled with the uncertain magnitude of clinical benefit and the reported rates of toxicity and treatment discontinuation, it is essential to critically evaluate both efficacy and safety in this specific patient subgroup. National and international guidelines recommend the integration of geriatric assessments into routine clinical practice to facilitate individualized treatment decisions; however, such assessments are not yet widely implemented in many oncology departments and are not routinely in use to guide adjuvant CDK4\u002F6i therapy.\n\nThis study aims to investigate the implementation of geriatric assessments in older breast cancer patients (≥70 years) and to examine multiple dimensions of CDK4\u002F6i treatment in this cohort, including short- and medium-term effects on quality of life, dose intensity, and clinical outcomes. By doing so, the investigators seek to more accurately delineate the benefits and risks of adjuvant CDK4\u002F6i therapy in this specific patient population.",[137,138,34],"Geriatric Assessment","Adjuvant Drug Therapy",[140,141,142,143],"Older patients","Geriatric screening","Adjuvant CDK4\u002F6 inhibitors","Breast cancer","2026-06-09",{"date":146,"type":51},"2026-06-10",{"date":148,"type":51},"2026-04-01",{"date":150,"type":23},"2039-08-01",{"name":152,"class":153},"Region Jönköping County","OTHER_GOV",5,{"id":156,"slug":157,"hasResults":12,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":162,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":163,"targetDuration":4,"studyType":24,"phases":165,"briefSummary":166,"conditions":167,"keywords":168,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":182},"100586587","phase-2-flash-breast-evaluating-the-efficacy-of-fezolinetant-in-reducing-vasomotor-symptoms-in-women-with-breast-cancer-on-endocrine-therapy-100586587","NCT06917313","FLASH-Breast: Evaluating the Efficacy of Fezolinetant in Reducing Vasomotor Symptoms in Women With Breast Cancer on Endocrine Therapy","A Randomized Phase II Study to Evaluate the Efficacy of Fezolinetant in Reducing Vasomotor Symptoms in Women With Breast Cancer on Endocrine Therapy","Inclusion Criteria:\n\nWomen with diagnosed, histologically confirmed, clinical stage I-III, HR+ invasive breast cancer as defined by ASCO CAP guidelines for whom adjuvant endocrine therapy would be indicated, regardless of HER2 status.\n\nAge 18 years and older.\n\nCurrently on endocrine therapy (tamoxifen or aromatase inhibitors) as part of standard of care treatment for HR+ breast cancer. Endocrine therapy may be administered with or without ovarian suppression and\u002For CDK4\u002F6 inhibitors as permitted in Section 7.1.1. Participants with HER2-positive disease are eligible and may receive concurrent HER2 monoclonal antibody therapy (e.g., trastuzumab or pertuzumab), but not HER2 antibody-drug conjugates (e.g., ado-trastuzumab emtansine T-DM1, or trastuzumab deruxtecan T-DXd).\n\nWilling and able to provide written informed consent\u002Fassent for the trial.\n\nPostmenopausal as defined by spontaneous amenorrhea for at least 12 consecutive months, spontaneous amenorrhea for at least 6 months with biochemical criteria or menopause (FSH \\> 40 IU\u002FL), or bilateral oophorectomy for at least 6 weeks before the screening visit, or if premenopausal chemically suppressed by GnRH agonist therapy with ultrasensitive estradiol level \\\u003C10.\n\nOn endocrine therapy for a minimum of 3 months and has planned duration of 12 weeks left in the treatment regimen. Participants receiving a CDK4\u002F6 inhibitor must have been on treatment for at least 4 weeks prior to enrollment.\n\nExperiencing an average of seven or more moderate to severe hot flashes per day over a 7-day period as documented by Symptom Diary during the Screening Period and seeking treatment or relief for VMS.\n\nAble to swallow oral formulation of the study agent.\n\nExclusion Criteria:\n\nParticipants who have a diagnosis of stage IV metastatic disease.\n\nReceiving any other cancer treatment other than endocrine therapy. This includes chemotherapy, targeted therapies, and immunotherapy.\n\nReceiving cytochrome CYP1A2 inhibitors.\n\nParticipants who have initiated, discontinued, or had a dose adjustment of treatment for vasomotor symptoms (prescription, over the counter, or herbal) within 28 days prior to screening.\n\nPregnant or lactating patients.\n\nKnown cirrhosis or active liver disease, jaundice, or elevated liver aminotransferases (ALT or AST) \\>2x ULN, or elevated total bilirubin, OR elevated direct bilirubin, or elevated INR, or elevated alkaline phosphatase \\>2x ULN.\n\nCreatinine \\> 1.5 times upper limit of normal; or estimated GFR ≤ 30 mL\u002Fmin per 1.73 m2 at screening.\n\nJudgement by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.",true,{"count":164,"type":23},92,[26],"This is a phase II, randomized, double-blinded, placebo-controlled trial designed to evaluate the efficacy of fezolinetant (45 mg a day) vs. placebo in reducing moderate to severe vasomotor symptoms (VMS) in breast cancer survivors on endocrine therapy (tamoxifen, aromatase inhibitors). The trial will proceed in a single stage, and the total of 92 participants will be randomized in 1:1 fashion to fezolinetant or placebo arm respectively.",[34],[169,170,171,172],"adjuvant endocrine therapy","vasomotor symptoms","tamoxifen","aromatase","2026-05-30",{"date":175,"type":51},"2026-06-02",{"date":177,"type":51},"2025-12-05",{"date":179,"type":23},"2028-03",{"name":181,"class":58},"Yale University",2,{"id":184,"slug":185,"hasResults":12,"nctId":186,"briefTitle":187,"officialTitle":187,"acronym":188,"eligibilityCriteria":189,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":190,"targetDuration":4,"studyType":24,"phases":192,"briefSummary":193,"conditions":194,"keywords":195,"overallStatus":198,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":59},"100638779","on-treatment-single-cell-analysis-for-the-identification-of-early-tumor-response-biomarkers-on-prospective-collected-serial-tumor-biopsies-in-triple-negative-breast-cancer-patient-during-standard-neoadjuvant-chemo-immunotherapy-100638779","NCT07597642","ON-treatment Single-cell Analysis for the Identification of Early Tumor Response Biomarkers on Prospective Collected Serial Tumor Biopsies in Triple Negative Breast Cancer Patient During Standard Neoadjuvant Chemo-immunotherapy","ONSET","Inclusion Criteria:\n\n1. Female patients aged ≥18 years.\n2. ECOG performance status 0-1.\n3. Histologically confirmed early breast cancer with one of the following molecular profiles:\n\n   * TNBC: ER and PR negative (IHC \\\u003C10%) and HER2 negative (IHC 0-1+ or FISH non-amplified).\n   * High-risk luminal (ER+\u002FHER2-): ER positive (IHC ≥10%) HER2 negative (IHC 0-1+ or FISH non-amplified), with high-risk features (e.g., Grade 3, PR-negative, high proliferation, high TILS).\n4. Clinical indication for neoadjuvant treatment according to standard practice:\n\n   * TNBC: cT1c and\u002For cN positive, or cT2 (\\>2 cm) and\u002For cN positive (stage II,III).\n   * High-risk luminal: features as defined above (Grade 3, PR-negative, high proliferation, ER low).\n5. Ability to understand and sign written informed consent for participation in the study, approved by the local Ethics Committee.\n\nExclusion Criteria:\n\n1. HER2-positive tumors.\n2. Multifocal tumors - exclusion if a single index lesion cannot be identified and sampled; otherwise allowed if a representative lesion can be biopsied.\n3. Known metastatic disease. 4 Clinical contraindications to the planned neoadjuvant therapy.\n\n5\\. Decision for upfront surgery as determined by the multidisciplinary team. 6. Inability to provide informed consent. 7. Pregnancy or breastfeeding. 8. Prior systemic therapy (chemotherapy, immunotherapy, or endocrine therapy) for the current breast cancer before baseline biopsy 9. On-treatment biopsy clinically not feasible or controindicated",{"count":191,"type":23},55,[71],"This study explores early breast cancer, focusing on triple-negative and high-risk luminal subtypes. It combines single-cell RNA sequencing and spatial imaging of tumor samples collected at different time points during treatment. The aim is to better understand how cancer cells and immune cells interact and to identify biomarkers that can predict whether a patient will respond to chemo-immunotherapy or develop resistance.\n\nThe study assumes that early molecular and spatial changes at the single-cell level can predict treatment response. This knowledge could help doctors adapt therapies, avoiding unnecessary treatment while improving effectiveness. The project seeks to reveal, for the first time, how cellular diversity and spatial relationships contribute to treatment resistance and disease progression.\n\nTumor samples will be analyzed before treatment, after the first treatment cycle (C1D1), and at surgery. Only the biopsy taken after C1D1 is collected specifically for this study; all other samples come from routine clinical care.",[34],[196,197],"triple negative breast cancer","high-risk luminal (ER+\u002FHER2neg)","NOT_YET_RECRUITING","2026-05-19",{"date":201,"type":51},"2026-05-22",{"date":203,"type":23},"2026-09",{"date":205,"type":23},"2029-03",{"name":207,"class":58},"IRCCS San Raffaele",{"id":209,"slug":210,"hasResults":12,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":4,"eligibilityCriteria":214,"healthyVolunteers":12,"sex":18,"minAge":215,"maxAge":216,"enrollmentInfo":217,"targetDuration":4,"studyType":24,"phases":219,"briefSummary":220,"conditions":221,"keywords":223,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":182},"100622732","feasibility-and-acceptibility-of-a-multi-site-trial-of-time-restircted-eating-during-chemotheraply-for-breast-cancer-100622732","NCT07387445","Feasibility and Acceptibility of a Multi-site Trial of Time Restircted Eating During Chemotheraply for Breast Cancer.","Time Restricted Eating During Chemotherapy for Breast Cancer","Inclusion Criteria:\n\n* Age 25-99 at time of consent\n* English language or Spanish language (based on availability of lab interpreters)\n* ECOG 0 or 1\n* Breast cancer to meet histologically confirmed Stage I-III or Stage IV with Medical Oncology approval.\n* Demonstrates adequate organ function (absolute neutrophil count ≥ 1,500\u002FμL).\n* All screening labs to be obtained within 30 days prior to registration.\n* Able to provide 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* 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* 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\n* Women with type 1 or insulin dependent type 2 diabetes\n* Women with BMI \\> 45kg\u002Fm2 and \\\u003C 18.5 kg\u002Fm2\n* Women who are pregnant or nursing. A negative serum or urine pregnancy test is required per institutional practice guidelines.\n* Shift workers\n* Women with a history of eating disorders\n* Enrolled participants with a significant weight loss or weight gain within 3 months of the study (weight gain or loss \\>4kg)\n* Uncontrolled HIV\u002FAIDS or active viral hepatitis\n* Any prior malignancy \\\u003C5 years, chemotherapy within the last year 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.\n* Breast cancer recurrence classified by the treating medical oncologist\n* Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial.\n* Other major comorbidity, as determined by study PI\n* Illicit drug use within previous 3 months or excessive use of alcohol (i.e., \\> 2 drinks\u002Fday)\n* Currently participating in Weight Watcher's or another weight loss program, including weight loss medication such as GLP-1 medications.\n* Myocardial infarction\n* Congestive heart failure\n* Chronic hepatitis\n* Cirrhosis\n* Chronic pancreatitis\n* History of solid organ transplantation","25 Years","99 Years",{"count":218,"type":23},40,[71],"This study is being done to better understand how time restricted eating (eating all food in an 8 hour window) can help a person receiving chemotherapy treatment for breast cancer, stages I-IV. The aim is to find out if time restricted is feasible and acceptable to individuals starting chemotherapy for breast cancer. We will test 3 different eating window options compared to a control group for 24 weeks.",[34,222,98],"Breast Neoplasm Female",[224,225,226,227,228],"breast cancer","fasting","intermittent fasting","time restricted eating","chemotherapy initiation","2026-04-27",{"date":231,"type":51},"2026-05-01",{"date":233,"type":51},"2026-02-01",{"date":235,"type":23},"2026-12-31",{"name":237,"class":58},"University of Illinois at Chicago",{"id":239,"slug":240,"hasResults":12,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":4,"eligibilityCriteria":244,"healthyVolunteers":12,"sex":18,"minAge":245,"maxAge":131,"enrollmentInfo":246,"targetDuration":4,"studyType":24,"phases":248,"briefSummary":249,"conditions":250,"keywords":252,"overallStatus":198,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":260,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":59},"100582626","collaborative-research-multiscale-modeling-and-intervention-for-improving-long-term-medication-100582626","NCT06865755","Collaborative Research: Multiscale Modeling and Intervention for Improving Long-Term Medication","Deploying and Evaluating a Technology Based System to Help People Adhere to Long Term Medications","Inclusion Criteria:\n\n* are English-speaking and reading;\n* are between ages 21 and 70 years;\n* are diagnosed with stage 0-3 breast cancer in the past 5 years;\n* have completed all surgery, radiation, and chemotherapy, except endocrine therapy;\n* are prescribed endocrine therapy;\n* do not have a physical impairment that would prevent them from using the MM system;\n* are able to provide informed consent;\n* are willing and able to use the MM system for 6 months;\n* have an Iphone or Android phone.","21 Years",{"count":247,"type":23},15,[71],"The goal of this study is to learn about the impact of an integrated medication monitoring system in breast cancer survivors aged 21-70 who are prescribed endocrine therapy. The main question it aims to address is: Does the integrated medication monitoring system improve medication adherence among breast cancer survivors when used over a six-month period?\n\nFifteen English-speaking breast cancer survivors who meet the inclusion criteria will use a combination of smartphone-based ecological momentary assessments, a medication event monitoring system (Wisepill), and a wearable sensor (Fitbit). After 2 months, participants will be provided personalized content to facilitate medication adherence through an app (Digital Trails) and through WisePill. Participants will complete online surveys at baseline, 3 months, and 6 months to assess their experiences and adherence.",[251,34],"Breast Cancer Survivor",[253,254,255,256,257,258,259],"Single-Arm Study Design","Medication Event Monitoring System (MEMS)","Medication Adherence","Breast Cancer Survivors","Personalized Interventions","endocrine therapy","mobile health",{"date":229,"type":51},{"date":262,"type":23},"2026-07",{"date":264,"type":23},"2026-12",{"name":266,"class":58},"San Diego State University",{"id":268,"slug":269,"hasResults":12,"nctId":270,"briefTitle":271,"officialTitle":271,"acronym":272,"eligibilityCriteria":273,"healthyVolunteers":162,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":274,"targetDuration":4,"studyType":24,"phases":276,"briefSummary":277,"conditions":278,"keywords":281,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":59},"100578146","evaluation-of-circulating-tumor-cells-ctc-relevance-in-breast-cancer-follow-up-using-the-screencell-device-100578146","NCT06807502","Evaluation of Circulating Tumor Cells (CTC) Relevance in Breast Cancer Follow-up Using the ScreenCell Device","PROBE-CTC","INCLUSION CRITERIA\n\nFor all participants :\n\n* Female with age greater than or equal to 18 years\n\nFor participants with metastatic breast cancer:\n\n\\- Patient observed with metastatic breast cancer from the outset or metastatic fall from previously treated breast cancer with change of therapeutic line at the time of inclusion.\n\nFor participants with non-metastatic invasive breast cancer:\n\n\\- Patient observed with non-metastatic infiltrative breast cancer who had not received any treatment at the time of inclusion (naïve to any treatment)\n\nFor healthy volunteers:\n\n* Participant free of any cancer at the time of inclusion, confirmed using a mammogram whose results must be satisfactory, done at the latest two years before inclusion\n* Participant with no history of cancer\n\nEXCLUSION CRITERIA\n\nFor all participants:\n\n* Male\n* Age less than 18 years old\n* Refusal to participate or withdrawal of consent\n* Pregnant and\u002For breastfeeding women\n* Discovery of a cancerous pathology (other than breast cancer for patients) during participant follow-up.\n\nFor healthy volunteers:\n\n* History of cancer\n* Detection of CTC (positive profile) during screening",{"count":275,"type":23},93,[71],"Liquid biopsy is a noninvasive method for detecting and quantifying circulating tumor cells (CTCs). Thanks to ScreenCell technology, this study aims to evaluate the evolution of the number of CTCs during breast cancer follow-up.\n\nThe identification and characterization of CTCs would make it possible to obtain information on the stage and molecular characteristics of cancer during follow-up",[279,280,34],"Breast Cancer, Metastatic","Breast Cancer Invasive",[282,283,284,98,285,286,287],"CTC","Circulating Tumor Cells","Detection","Follow-up","Liquid Biopsy","Blood Test","2026-04-21",{"date":290,"type":51},"2026-04-24",{"date":292,"type":51},"2025-02-24",{"date":294,"type":23},"2026-11-30",{"name":296,"class":297},"ScreenCell","INDUSTRY",{"id":299,"slug":300,"hasResults":12,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":304,"eligibilityCriteria":305,"healthyVolunteers":12,"sex":18,"minAge":131,"maxAge":4,"enrollmentInfo":306,"targetDuration":4,"studyType":24,"phases":308,"briefSummary":309,"conditions":310,"keywords":312,"overallStatus":198,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":323,"startDateStruct":325,"completionDateStruct":326,"leadSponsor":328,"locationsCount":330},"100623552","cryo-1-cryoablation-in-elderly-patients-with-early-stage-breast-cancer-100623552","NCT07398118","CRYO-1: Cryoablation in Elderly Patients With Early-Stage Breast Cancer.","Treatment of Elderly Patients With Early Stage Breast Cancer (CRYO-1): The Efficacy of Cryoablation In The Elderly - A Phase II Multicentre, Feasibility Study.","CRYO-1","Inclusion Criteria:\n\n* Age ≥ 70 years\n* Histologically confirmed invasive breast cancer\n* Clinical stage cT1N0M0 based on mammography and ultrasound ER-positive, HER2-negative (IHC 0-1+ or 2+ with negative ISH), any PR status\n* Presence of concurrent DCIS is allowed if limited to \\\u003C25% of the pre-NST biopsy, with no radiologic suspicion of an extensive component\n* Unifocal disease \\\u003C2 cm, well visualized on ultrasound, with a minimum distance of ≥5 mm from the skin, nipple and thoracic wall\n* Ability and willingness to comply with project requirements\n* Preoperative endocrine therapy is allowed\n* Written informed consent given by the subject\n\nExclusion Criteria:\n\n* Pure DCIS lesions without invasive component\n* Extensive calcifications on imaging suggestive of widespread disease\n* Invasive lobular carcinoma (as assessed by IHC)\n* Triple-negative or HER2-positive subtype (defined as (IHC 3+ or ISH positive)\n* History of ipsilateral breast cancer or DCIS\n* Prior ipsilateral radiotherapy\n* Inability to communicate in Dutch or English language\n* Planned (e)migration or long-term stay abroad within one year after inclusion",{"count":307,"type":23},61,[71],"This study looks at a new way to treat early-stage breast cancer in older adults using a freezing technique called cryoablation.\n\nOlder adults with early-stage breast cancer are usually treated with surgery or primary endocrine therapy (hormone therapy). While these treatments can be effective, they may also be burdensome. Surgery can lead to pain, slow recovery, or complications, and primary endocrine therapy often requires long-term medication and may cause side effects or stop working over time. Cryoablation may offer a less invasive treatment option.\n\nThe goal of this study is to find out whether cryoablation can be safely and successfully used as the main treatment for older adults with early-stage breast cancer. Cryoablation destroys the tumour by freezing it. The procedure is performed through the skin using imaging guidance and does not involve surgical removal of the tumour.\n\nParticipants in this study are adults aged 70 years or older who have a small breast tumour that has not spread to the lymph nodes. All participants receive cryoablation as a single treatment.\n\nAfter the procedure, participants are followed closely. Researchers will collect information on side effects, recovery, whether additional treatment is needed, and how participants experience the treatment. Quality of life will also be assessed.\n\nThis study is carried out in several hospitals. All participants must give written informed consent before taking part. The results of this study may help determine whether cryoablation could be a safe and practical treatment option for older adults with early-stage breast cancer and guide future research.",[311,34],"Breast Cancer Stage I",[313,37,314,315,316,317,318,319,320,321],"Cryoablation","Non-curative","Elderly","Minimally invasive treatment","Breast tumour","Local tumour control","Feasibility study","Cryotherapy","Non-surgical treatment","2026-03-20",{"date":324,"type":51},"2026-03-23",{"date":148,"type":23},{"date":327,"type":23},"2028-06-30",{"name":329,"class":58},"St. Antonius Hospital",3,{"id":332,"slug":333,"hasResults":12,"nctId":334,"briefTitle":335,"officialTitle":336,"acronym":337,"eligibilityCriteria":338,"healthyVolunteers":12,"sex":90,"minAge":19,"maxAge":4,"enrollmentInfo":339,"targetDuration":4,"studyType":24,"phases":341,"briefSummary":342,"conditions":343,"keywords":351,"overallStatus":198,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":360,"startDateStruct":361,"completionDateStruct":363,"leadSponsor":365,"locationsCount":59},"100580200","advancing-care-coordination-between-cancer-and-primary-care-teams-for-complex-cancer-survivors-100580200","NCT06834204","Advancing Care Coordination Between Cancer and Primary Care Teams for Complex Cancer Survivors","ACCESS-PC: Advancing Care Coordination to Enhance Shared Care for Complex Cancer Survivors in Primary Care.","ACCESS-PC","Inclusion Criteria:\n\n* diagnosed with any of the following cancers \\[Stage I-III\\]: breast, prostate, urinary bladder, and endometrial in the past 6 months;\n* being treated for cancer with curative intent;\n* had initial patient visit at the cancer center in the last 3 months;\n* are being treated for cancer with curative intent at the Rutgers Cancer Institute of New Jersey\n* have ≥1 CVD risk factor (hypertension, hyperlipidemia or type II diabetes) prior to cancer diagnosis that requires medication management;\n* currently receiving care from a primary care provider;\n* Speak English or Spanish\n\nExclusion Criteria:\n\n* had myocardial infarction or stroke within the previous 1 year;\n* have heart failure with an ejection fraction \\\u003C30%; (3) have stage IV-V chronic kidney disease (eGFR \\\u003C30);\n* or do not speak English or Spanish. Patients whose cancer progresses to metastatic disease during the course of the 18-month trial will be allowed to continue to participate unless they voluntarily withdraw",{"count":340,"type":23},266,[71],"The purpose of this randomized clinical trial is to learn if 'complex' cancer patients who receive care guided by a health system intervention, Primary Care Connect (PC2) have their risks of cardiovascular disease (CVD) managed better than those who receive usual care. This study focuses on \"complex\" cancer survivors who have higher CVD risk when diagnosed with cancer because they also have had a diagnosis of 1 or more chronic conditions (e.g., hypertension, diabetes, and\u002For hyperlipidemia) requiring medication management. This study also aims to learn about the ease of implementing the health system intervention from the perspectives of cancer teams, primary care teams, and complex cancer patients.\n\nThe main questions the study aims to answer are:\n\n* Do patients enrolled in the PC2 arm remain connected to their primary care teams during active cancer treatment for chronic disease management compared to patients in usual care?\n* Do patients enrolled in the PC2 arm have better management of their chronic conditions during active cancer treatment compared to patients in usual care?\n* How do the care team and patients experience this change in care delivery related to their work and care experiences?\n\nThis study will compare complex cancer survivors who receive care according to the PC2 intervention to usual care to see if PC2 works to improve cardiovascular risk management.\n\nParticipants will:\n\n* receive educational materials about the study upon enrollment\n* complete on-line or written surveys at 4 times\n* Visit the clinic for check ups and test related to the study 4 times",[344,34,345,346,347,348,349,350],"Cancer","Bladder Cancer","Prostate Cancer (Adenocarcinoma)","Endometrial Cancer","Hypertension","Hyperlipidemia (E.G., Hypercholesterolemia)","Diabetes Mellitus",[352,353,354,355,356,357,358,359],"primary care","cancer","cardiovascular","shared care","care coordination","implementation","cancer multi-team system","complex cancer survivor",{"date":324,"type":51},{"date":362,"type":23},"2026-04-15",{"date":364,"type":23},"2029-04-30",{"name":366,"class":58},"Rutgers, The State University of New Jersey",{"id":368,"slug":369,"hasResults":12,"nctId":370,"briefTitle":371,"officialTitle":372,"acronym":373,"eligibilityCriteria":374,"healthyVolunteers":12,"sex":90,"minAge":19,"maxAge":4,"enrollmentInfo":375,"targetDuration":4,"studyType":134,"phases":4,"briefSummary":376,"conditions":377,"keywords":378,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":380,"lastUpdatePostDateStruct":381,"startDateStruct":383,"completionDateStruct":385,"leadSponsor":387,"locationsCount":59},"100571725","evaluation-of-her2dx-assay-on-treatment-decisions-in-patients-with-early-stage-her2-breast-cancer-the-her2breastdx-100571725","NCT06723990","Evaluation of HER2DX Assay on Treatment Decisions in Patients With Early Stage HER2+ Breast Cancer: the HER2BREASTDX","Prospective Observational Monocentric Study to Evaluate the Impact of the HER2DX Assay on Treatment Decisions in Patients With Early Stage HER2+ Breast Cancer: the HER2-BREAST-DX","HER2BREASTDX","Inclusion Criteria:\n\n* Patients ≥ 18 years of age;\n* Histologically confirmed HER2+ breast cancer;\n* Stage I-III breast cancer without evidence of distant metastases;\n* Being candidate to neoadjuvant\u002Fadjuvant therapy and locoregional treatment (surgery +\u002F- radiotherapy);\n* Written informed consent, signed by the patient, to study-specific procedures (the consent will consist of 2 levels: level 1 specifically for patients enrolled in the primary endpoint cohort and level 2 for all patients);\n\nExclusion Criteria:\n\n* HER2- BC;\n* Stage IV breast cancer;\n* Lack of informed consent because of patient's incapable of discernment or unwilling to participate;",{"count":69,"type":23},"To prospectively evaluate the impact of HER2DX on the decision-making processes of the treating physicians and especially among the routine multidisciplinary tumour board, in defining type and setting of systemic therapy administration in patients with stage I-III HER2+ BC, and the degree of clinician's confidence in the treatment recommendation.",[34],[379],"HER2 positive breast cancer patients with stage I-III","2026-02-09",{"date":382,"type":51},"2026-02-11",{"date":384,"type":51},"2024-10-24",{"date":386,"type":23},"2027-11",{"name":388,"class":58},"European Institute of Oncology",{"id":390,"slug":391,"hasResults":12,"nctId":392,"briefTitle":393,"officialTitle":394,"acronym":4,"eligibilityCriteria":395,"healthyVolunteers":12,"sex":18,"minAge":67,"maxAge":396,"enrollmentInfo":397,"targetDuration":4,"studyType":24,"phases":399,"briefSummary":401,"conditions":402,"keywords":403,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":409,"lastUpdatePostDateStruct":410,"startDateStruct":412,"completionDateStruct":414,"leadSponsor":416,"locationsCount":59},"100621681","phase-2-continuous-positive-airway-pressure-cpap-assisted-radiotherapy-in-breast-cancer-100621681","NCT07373782","Continuous Positive Airway Pressure (CPAP) Assisted Radiotherapy in Breast Cancer","Reducing Cardiac Radiation Dose in Continuous Positive Airway Pressure (CPAP) Assisted Radiotherapy in Breast Cancer: a Prospective Non-Randomized Clinical Trial","Inclusion Criteria:\n\n1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures\n2. At least 40 years of age and 80 years or younger at the time of signing the Informed Consent Form (ICF)\n3. Female patients\n4. Patients that underwent breast conserving surgery (BCS)\n5. Left-sided invasive BC \u002F in situ carcinoma with indication for adjuvant RT (\\\u003C70 years old)\n6. Left-sided invasive BC with indication for adjuvant locoregional RT (including RT of the regional lymph nodes) (70-80 years old)\n7. Right-sided invasive BC with indication for adjuvant locoregional RT (including RT of the regional lymph nodes)\n8. Prior chemotherapy allowed\n9. Prior immunotherapy allowed\n10. Prior \u002F concomitant hormonal therapy allowed\n11. Prior \u002F concomitant HER2-targeted therapy allowed\n\nExclusion Criteria:\n\n1. Patient has active bullous lung disease, bypassed upper airway, pneumothorax, cerebral spinal fluid leaks, abnormalities of the cribriform plate (contra-indications for the use of CPAP)\n2. Patient has history of major head trauma and\u002For pneumocephalus (contra-indications for the use of CPAP)\n3. Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the CIP.\n4. Female who is pregnant, breast-feeding or intends to become pregnant (which is a contra-indication for RT in general)\n5. Male BC patients\n6. Patients that underwent mastectomy Patients whose initial tumor was located just beneath the skin (defined as being less than 28mm below the breast surface), indicating the need for an electron boost\n7. Patients requiring RT boost on positive lymph nodes\n8. Distant metastasis\n9. Breast implants in situ\n10. Right-sided in situ carcinoma\n11. Right-sided invasive BC only requiring local adjuvant RT (without irradiation of the regional lymph nodes, because the presumed benefit on cardiac doses of local right-sided breast irradiation is assumed to be rather small because of the left anatomical position of the heart)\n12. Bilateral BC\n13. Concomitant use of chemotherapy during RT\n14. Substantial comorbidities, incompatible with RT or CPAP use, estimated by the treating radiation oncologist\n15. Insufficient arm mobility to perform comfortable arm positioning in radiation treatment position, evaluated by the treating radiation oncologist\n16. Other active oncological disease \u002F treatment with the exception of non-melanoma skin cancer\n17. Previous RT with overlapping RT fields with actual target volume","80 Years",{"count":398,"type":23},53,[26,400],"PHASE3","This study is a prospective, non-randomized clinical study aimed at investigating the potential benefits of continuous positive airway pressure (CPAP) support during radiotherapy for breast cancer. CPAP is a device commonly used to support breathing, for example in patients with sleep apnea. The investigators expect a reduction in radiation doses to the heart and\u002For lungs with CPAP-supported radiotherapy compared to standard radiotherapy (without CPAP), which may also lead to a decrease in radiation-induced heart and\u002For lung conditions in the long term. The study will also examine how the use of a CPAP device can be implemented in daily radiotherapy practice.",[34],[224,404,405,406,407,408],"radiotherapy","cpap","continuous positive airway pressure","dosimetry","toxicity","2026-01-22",{"date":411,"type":51},"2026-01-28",{"date":413,"type":51},"2025-02-11",{"date":415,"type":23},"2027-06",{"name":417,"class":58},"Universitaire Ziekenhuizen KU Leuven",{"id":419,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":420,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":421,"targetDuration":4,"studyType":24,"phases":422,"briefSummary":27,"conditions":423,"keywords":424,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":425,"lastUpdatePostDateStruct":426,"startDateStruct":428,"completionDateStruct":429,"leadSponsor":430,"locationsCount":59},"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":22,"type":23},[26],[29,30,31,32,33,34],[36,37,38,39,40,41,42,43,44,45,46],"2026-01-18",{"date":427,"type":51},"2026-01-21",{"date":53,"type":51},{"date":55,"type":23},{"name":57,"class":58},{"id":432,"slug":433,"hasResults":12,"nctId":434,"briefTitle":435,"officialTitle":436,"acronym":437,"eligibilityCriteria":438,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":439,"targetDuration":4,"studyType":24,"phases":441,"briefSummary":442,"conditions":443,"keywords":445,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":451,"lastUpdatePostDateStruct":452,"startDateStruct":454,"completionDateStruct":456,"leadSponsor":457,"locationsCount":59},"100601215","multimodal-prehabilitation-program-that-combines-physical-exercise-psychological-intervention-and-nutritional-support-to-improve-the-response-to-neoadjuvant-chemoterhapy-in-early-breast-cancer-patients-100601215","NCT07107594","Multimodal Prehabilitation Program That Combines Physical Exercise, Psychological Intervention and Nutritional Support to Improve the Response to Neoadjuvant Chemoterhapy in Early Breast Cancer Patients","Multimodal Intervention During Neoadjuvant Chemotherapy in Patients With Early-breast Cancer as a Strategy to Improve Treatment Response: DIANA Trial (Multimodal Prehabilitation: DIet, ANxiety Control Psychotherapy, Physical Activity)","DIANA","Inclusion Criteria:\n\n* Histologically confirmed diagnosis of non-metastatic breast cancer: stages cT1-T4, cN0-N3, M0, and candidates for neoadjuvant chemotherapy (NAC).\n* Age ≥ 18 years.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Contraindication or physical inability to perform moderate-to-high intensity physical exercise.\n* Pregnant or breastfeeding patients.\n* Presence of other active synchronous neoplasms.\n* Metastatic breast cancer (stage IV).\n* Patients already engaging in regular physical exercise: more than 150 minutes of moderate or intense aerobic exercise per week.\n* Male breast cancer patients.\n* Personal history of a previous malignancy treated with chemotherapy.\n* Severe or poorly controlled psychiatric illness (including uncontrolled active substance abuse).",{"count":440,"type":23},214,[71],"The aim of this clinical trial is to evaluate whether following a multimodal prehabilitation program including physical exercise, nutritional support and psychological intervention during neoadjuvant chemotherapy in breast cancer patients could improve the pathological response to chemotherapy.\n\n214 women with non-metastatic breast cancer with indication of chemotherapy before surgery will be eligible to participate. Patients will be randomly assigned to either the intervention group or the control group.\n\n* Patients assigned to the intervention group (107 women) will undergo a directed multimodal prehabilitation program during the chemotherapy (4-6 months), including structured physical exercise, psychological intervention and nutritional guidance.\n* Patients assigned to the control group (107 women) will undergo standard clinical management for their disease without multimodal prehabilitation.\n\nThe response to chemotherapy between the two groups will be evaluated and compared. It is expected that multimodal prehabilitation will increase the response to chemotherapy and will improve the postoperative recovery of patients and their quality of life, as well as reducing the number of complications from surgery and chemotherapy treatment. Changes in the tumor microenvironment are also expected after prehabilitation.",[34,444],"Prehabilitation",[143,446,444,447,448,449,450],"Early breast cancer","Multimodal prehabilitation","Neoadjuvant chemotherapy","Lifestyle","Quality of life","2026-01-14",{"date":453,"type":51},"2026-01-15",{"date":455,"type":51},"2025-01-14",{"date":179,"type":23},{"name":458,"class":58},"Hospital Clinic of Barcelona",{"id":460,"slug":461,"hasResults":12,"nctId":462,"briefTitle":463,"officialTitle":463,"acronym":4,"eligibilityCriteria":464,"healthyVolunteers":162,"sex":18,"minAge":67,"maxAge":131,"enrollmentInfo":465,"targetDuration":4,"studyType":134,"phases":4,"briefSummary":466,"conditions":467,"keywords":475,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":478,"lastUpdatePostDateStruct":479,"startDateStruct":480,"completionDateStruct":482,"leadSponsor":484,"locationsCount":59},"100618429","validation-of-the-oncoliq-test-for-the-early-detection-of-breast-cancer-100618429","NCT07331506","Validation of the Oncoliq Test for the Early Detection of Breast Cancer.","Inclusion Criteria:\n\nGroup 1 - Breast Cancer:\n\nAge between 40 and 70 years Diagnosis of breast cancer at any stage No prior surgical treatment No prior antineoplastic treatment Pathology report available at the time of enrollment Signed informed consent\n\nGroup 2 - No Cancer (Control):\n\nAge between 50 and 70 years No diagnosis or personal history of any type of cancer Digital mammography and breast ultrasound showing no breast pathology (BI-RADS 1 or 2) Signed informed consent\n\nExclusion Criteria:\n\nRefusal to sign the informed consent Communication issues that hinder understanding (hearing loss, blindness, intellectual disability, or dementia) Venipuncture for blood collection impracticable or posing a risk Personal history of previous cancer",{"count":93,"type":23},"Cancer continues to be one of the most significant public health issues worldwide. Thanks to early detection, the mortality rate of certain types of cancer has decreased significantly. However, the lack of accessible, low-cost, non-invasive, non-toxic, and easy-to-implement diagnostic methods results in late diagnoses, leading to 1 in every 6 people dying from cancer today.\n\nMicroRNAs (miRNAs) are small non-coding RNAs that regulate gene expression and are found both inside cells and in bodily fluids such as blood and urine. Several studies have demonstrated their role in human diseases, especially cancer, where tumors release miRNAs into the bloodstream that can be used as biomarkers for early detection.\n\nThe research and development team at Oncoliq SAS identified a panel of miRNAs associated with breast cancer, with a detection performance of 82% sensitivity and 83% specificity, validated in exploratory and preliminary confirmatory studies. These results led to the filing of a patent based on liquid biopsy technology.\n\nThe objective of this protocol is to establish a panel of miRNAs for the early detection of breast cancer using samples from breast cancer patients and a cancer-free control group. Validation of the miRNAs will be carried out through RT-qPCR. This stage constitutes the analytical validation of the biomarkers, with the goal of developing an algorithm capable of classifying individuals with and without breast cancer. In future stages, a pilot clinical trial is planned to evaluate test implementation and clinical validation.",[468,34,469,470,471,472,473,474],"Breast Cancer Detection","Breast Cancer Female","Breast Cancer - Ductal Carcinoma in Situ (DCIS)","Breast Cancer - Infiltrating Ductal Carcinoma","Breast Cancer With Low to Intermediate HER2 Expression","Breast Cancer (Early Breast Cancer)","Breast Cancer - Female",[143,284,476,477],"Liquid biopsy","miRNAs","2026-01-13",{"date":453,"type":51},{"date":481,"type":51},"2025-10-17",{"date":483,"type":23},"2026-02-28",{"name":485,"class":297},"Oncoliq US Inc",{"id":487,"slug":488,"hasResults":12,"nctId":489,"briefTitle":490,"officialTitle":491,"acronym":4,"eligibilityCriteria":492,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":493,"targetDuration":4,"studyType":24,"phases":495,"briefSummary":496,"conditions":497,"keywords":499,"overallStatus":198,"whyStopped":4,"lastUpdateSubmitDate":505,"lastUpdatePostDateStruct":506,"startDateStruct":508,"completionDateStruct":510,"leadSponsor":512,"locationsCount":59},"100617373","phase-2-chemotherapy-with-or-without-adebrelimab-and-t-dxh-as-neoadjuvant-therapy-for-hrher2-low-early-stage-breast-cancer-100617373","NCT07317778","Chemotherapy With or Without Adebrelimab and T-DXh as Neoadjuvant Therapy for HR+\u002FHER2 Low Early Stage Breast Cancer","Chemotherapy Combine With or Without Adebrelimab and Trastuzumab Rezetecan(SHR-A1811) as Neoadjuvant Therapy for Hormone Receptor Positive\u002FHER2 Low Early Stage Breast Cancer: A Randomized Phase II Trial","Inclusion Criteria:\n\n* ECOG score: 0-1;\n* Pathologically confirmed invasive breast cancer, with tumor stage T1c-T2, cN1-2 or T3-4 cN0-2;\n* HR positive\u002FHER2 low expression(defined as HER2 IHC 1+\u002F2+, FISH negative);\n* Known PD-L1 expression status, or sufficient tumor tissue for PD-L1 testing;\n* Sufficient organ function\n* Female patients who have not undergone menopause or sterilization, accept for abstain from sexual activity or use an effective contraceptive method during the treatment period and at least 7 months after the last administration of the study medication;\n* Voluntarily participate and sign the informed consent form.\n\nExclusion Criteria:\n\n* Inflammatory breast cancer;\n* Previously received anti-tumor therapy or radiotherapy for any malignant tumor(not including cured cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma);\n* Concurrently received anti-tumor therapy in other clinical trials, including endocrine therapy, bisphosphonate therapy or immunotherapy;\n* Within 4 weeks before enrollment, underwent major surgical procedures unrelated to breast cancer, or the patient has not fully recovered from such procedures;\n* Had clinically significant pulmonary diseases, including but not limited to interstitial pneumonia, pneumonia, pulmonary fibrosis and radiation pneumonia (except for radiological changes that do not require treatment), or was found to have such diseases during the screening period;\n* Had any cardiac diseases, including: (1) Severe \u002F unstable angina pectoris; (2) Requires drug treatment or has clinically significant arrhythmia; (3) Had a myocardial infarction within 6 months before enrollment; (4) Has symptomatic congestive heart failure with NYHA grade ≥ II; (5) Any other heart diseases judged by the researcher as not suitable for participation in this trial;\n* Known to have had an allergic history to the components of the drug in this protocol; have a history of immunodeficiency, including positive HIV test, or have other acquired or congenital immune deficiency diseases, or have a history of organ transplantation;\n* Had severe comorbidities or other conditions that would interfere with the planned treatment, or any other situation that the researcher considered the patient was not suitable for participation in this study.",{"count":494,"type":23},249,[26],"The goal of this clinical trial is to learn if add SHR-A1811 and\u002For Adebrelimab on standard chemotherapy could further improve the pCR rate in HR+\u002FHER2 low early stage breast cancer patients. It will also learn about the safety of these combination regimen. The main questions it aims to answer are:\n\nIs Adebrelimab plus chemotherapy better than T-EC chemotherapy alone in neoadjuvant setting of HR+\u002FHER2-low early stage population? Is SHR-A1811-EC plus Adebrelimab better than T-EC chemotherapy and\u002For Adebrelimab plus chemotherapy\n\nParticipants will:\n\nTake 8 cycles of standard chemotherapy at day1, every 3 weeks cycle(standard care), or take 8 cycles of adebrelimab plus standard chemotherapy at day 1, every 3 weeks cycle(experimental 2), or take 4 cycles of SHR-A1811 and Adebrelimab at day 1, every 3 weeks cycle, then 4 cycles of adebrelimab plus EC chemotherapy at day 1, every 3 weeks cycke(experimental 1).\n\nVisit the clinic once every 6 weeks at neoadjuvant period for tumor assessment. Take surgery after completion of 8 cycles of neoadjuvant therapy and assess the pathological response. Then, visit the clinic once every 12 weeks at first year and then every 6 months for tumor assessment.",[34,498],"HR Positive\u002FHER2 Low Breast Cancer",[500,501,502,503,504],"SHR-A1811","adebrelimab","Trastuzumab Rezetecan","HR+\u002FHER2-low","early stage breast cancer","2025-12-24",{"date":507,"type":51},"2026-01-05",{"date":509,"type":23},"2026-02-15",{"date":511,"type":23},"2033-09-15",{"name":513,"class":58},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences",{"id":515,"slug":516,"hasResults":12,"nctId":517,"briefTitle":518,"officialTitle":519,"acronym":520,"eligibilityCriteria":521,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":131,"enrollmentInfo":522,"targetDuration":524,"studyType":134,"phases":4,"briefSummary":525,"conditions":526,"keywords":527,"overallStatus":198,"whyStopped":4,"lastUpdateSubmitDate":531,"lastUpdatePostDateStruct":532,"startDateStruct":534,"completionDateStruct":536,"leadSponsor":538,"locationsCount":330},"100616877","cellular-level-fluorescence-imaging-for-intraoperative-margin-assessment-in-breast-cancer-100616877","NCT07311317","Cellular-Level Fluorescence Imaging for Intraoperative Margin Assessment in Breast Cancer","Assessment of the Accuracy of a Novel Cellular-Level Fluorescence-Guided Imaging Technique in Scanning Tumor Margins During Breast Tumor Resection: A Prospective, Self-Controlled Study","FLASH","Inclusion Criteria:\n\n* Age between 18 - 70 years\n* Patients scheduled for breast tumor resection\n* Clinically or radiologically showing a solitary lesion and\n\n  1. (Before neoadjuvant chemotherapy) Maximum tumor diameter ≤ 5cm;\n  2. cN0-1;\n  3. No clinical or imaging evidence of nipple, skin, chest wall invasion, or distant metastasis before surgery.\n* Subjects voluntarily sign informed consent or are exempted from signing upon approval by the ethics committee.\n\nExclusion Criteria:\n\n* Inflammatory breast cancer;\n* Patients allergic to methylene blue and sodium fluorescein;\n* Unable to understand the trial requirements or unable to complete the study follow-up plan;\n* Pregnant and breastfeeding women;\n* Patients unable to complete follow-up due to mental illness, cognitive or emotional disorders;\n* Those with severe comorbidities (such as organ dysfunction, immune deficiency) or poor general condition;\n* Those participating in other clinical studies that may affect this trial;\n* Those for whom satisfactory specimens for both frozen pathology and paraffin pathology cannot be obtained during surgery;\n* Those who cannot obtain a paraffin pathology report.",{"count":523,"type":23},165,"1 Month","Accurate intraoperative margin assessment in breast cancer surgery remains challenging. Current reliance on frozen section pathology is limited by prolonged processing time, sampling constraints, and resource intensity, contributing to variable outcomes.\n\nThe EndoSCell Scanner is a novel cellular-resolution fluorescence-guided imaging technology designed to address these limitations. It enables real-time, pathology-level visualization of malignant cellular features at the surgical bed. With a 3mm probe allowing comprehensive 360° margin assessment, it reduces procedural time to under five minutes and may significantly lower secondary surgery rates.\n\nThis prospective, self-controlled study aims to evaluate the accuracy of the EndoSCell Scanner for intraoperative margin assessment in patients undergoing mastectomy. Its performance will be systematically compared against both frozen section and final paraffin pathology to validate sensitivity and operational efficiency. If proven effective, this technology could become a standard adjunct tool, standardizing precision in breast cancer surgery and improving patient outcomes by enhancing surgical consistency.",[34],[528,529,530],"Breast Cancer,","Fluorescence-guided","Cellular","2025-12-20",{"date":533,"type":51},"2025-12-30",{"date":535,"type":23},"2026-01",{"date":537,"type":23},"2027-01",{"name":539,"class":58},"West China Hospital",{"id":541,"slug":542,"hasResults":12,"nctId":543,"briefTitle":544,"officialTitle":545,"acronym":4,"eligibilityCriteria":546,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":131,"enrollmentInfo":547,"targetDuration":4,"studyType":24,"phases":549,"briefSummary":550,"conditions":551,"keywords":552,"overallStatus":198,"whyStopped":4,"lastUpdateSubmitDate":554,"lastUpdatePostDateStruct":555,"startDateStruct":557,"completionDateStruct":559,"leadSponsor":561,"locationsCount":59},"100613676","phase-3-rasolve-125i-radioactive-seed-marking-effects-on-pathological-complete-response-rate-and-prognosis-post-neoadjuvant-therapy-in-earlyadvanced-breast-cancer-100613676","NCT07269691","RaSOLVE: 125I Radioactive Seed Marking Effects on Pathological Complete Response Rate and Prognosis Post-Neoadjuvant Therapy in Early\u002FAdvanced Breast Cancer","RaSOLVE: An Open-Label, Controlled, Randomized, Multicenter Phase III Clinical Trial Assessing the Impact of Preoperative 125I Radioactive Seed Localization on Pathological Complete Response Rate (tpCR: ypT0\u002Fis ypN0) and Long-Term Prognosis (iDFS\u002FOS) in Women With Early or Locally Advanced Newly Diagnosed Untreated Breast Cancer Following Neoadjuvant Therapy","Inclusion Criteria:\n\n* Female patients aged 18 to 70 years.\n* ECOG performance status 0-1.\n* Pathologically confirmed, previously untreated, unilateral primary invasive breast cancer.\n* Clinical stage cT1cN1-2M0 or cT2-3N0-2M0 (AJCC 8th edition).\n* Adequate organ function within 7 days prior to randomization:\n\n  * Hemoglobin ≥ 90 g\u002FL\n  * ANC ≥ 1.5×10⁹\u002FL; Lymphocyte count ≥ 0.5×10⁹\u002FL\n  * Platelet count ≥ 100×10⁹\u002FL\n  * WBC 3.0-15×10⁹\u002FL\n  * ALT, AST ≤ 2.5×ULN; ALP ≤ 2.5×ULN; TBIL ≤ 1.5×ULN\n  * Serum creatinine ≤ 1.5×ULN and creatinine clearance ≥ 60 mL\u002Fmin\n  * PT, APTT ≤ 1.5×ULN\n  * Urine protein \\\u003C 2+ or 24-hour urine protein ≤ 1 g\n  * LVEF ≥ 55%\n  * QTcF \\\u003C 470 ms\n* Negative serum pregnancy test within 3 days prior to first treatment for women of childbearing potential and agreement to use effective contraception.\n* Willing and able to sign informed consent.\n\nExclusion Criteria:\n\n* Bilateral breast cancer or history of DCIS, LCIS, invasive breast cancer, or metastatic breast cancer.\n* Any malignancy diagnosed within the past 5 years except cured cervical carcinoma in situ or non-melanoma skin cancer.\n* Prior systemic chemotherapy, targeted therapy, immunotherapy, or radiotherapy within 1 year.\n* Prior exposure to anthracyclines, taxanes, or platinum agents.\n* Primary or secondary immunodeficiency; uncontrolled autoimmune disease (except controlled hypothyroidism or type 1 diabetes).\n* Interstitial lung disease or severe chronic lung disease.\n* Clinically significant cardiovascular disease, including:\n\n  * NYHA class ≥ III\n  * Myocardial infarction or stroke within 3 months\n  * Uncontrolled hypertension\n  * Clinically significant arrhythmia or heart failure\n* Arterial\u002Fvenous thrombosis within 3 months.\n* Vaccination with live attenuated vaccine within 28 days.\n* Active HBV, HCV, or HIV infection.\n* Major surgery within 28 days (except diagnostic procedures).\n* Severe infection within 4 weeks or systemic antibiotic-treated infection within 2 weeks.\n* History of bone marrow or organ transplantation.\n* Coagulation abnormalities (INR \\> 1.5 or APTT \\> 1.5×ULN).\n* Peripheral neuropathy ≥ Grade 2.\n* Treatment with systemic immunostimulatory agents within 4 weeks or immunosuppressive agents within 2 weeks.\n* Known allergy to study agents.\n* Participation in another clinical trial within 4 weeks.\n* Pregnancy, breastfeeding, or planning pregnancy.\n* Substance abuse or psychiatric conditions that may affect compliance.\n* Any condition that, in the investigator's judgment, makes the patient unsuitable for the study.",{"count":548,"type":23},194,[400],"This study is an open-label, controlled, multicenter phase III clinical trial designed to evaluate whether the use of iodine-125 radioactive seed markers can improve treatment response for patients with early or locally advanced breast cancer undergoing neoadjuvant therapy.\n\nNeoadjuvant therapy is widely used for breast cancer to shrink tumors, increase the chances of breast-conserving surgery, and help determine the most effective postoperative treatments. Achieving a pathological complete response (pCR) after neoadjuvant therapy is strongly associated with better long-term outcomes.\n\nIn this study, qualified participants will be randomly assigned in a 1:1 ratio to either the experimental group or the control group.\n\nExperimental group: Patients will receive placement of iodine-125 seed markers in the primary breast tumor and biopsy-proven positive axillary lymph nodes before starting neoadjuvant therapy.\n\nControl group: Patients will undergo standard neoadjuvant therapy without seed placement.\n\nAll participants will then complete neoadjuvant therapy followed by surgery. Pathological evaluation will determine whether the cancer has completely disappeared. Long-term outcomes, including invasive disease-free survival, will be followed for at least five years.\n\nThe goal of this study is to determine whether radioactive seed marking can increase the rate of pathological complete response and improve prognosis in patients receiving neoadjuvant therapy for breast cancer. The study will also explore whether iodine-125 seeds may activate immune responses that contribute to treatment effectiveness.",[34,98],[553],"Iodine-125 seed Radioactive seed marking Breast cancer Neoadjuvant therapy Pathological complete response","2025-11-26",{"date":556,"type":51},"2025-12-08",{"date":558,"type":23},"2025-12-01",{"date":560,"type":23},"2027-12-01",{"name":562,"class":58},"Pengfei Qiu",{"id":564,"slug":565,"hasResults":12,"nctId":566,"briefTitle":567,"officialTitle":568,"acronym":569,"eligibilityCriteria":570,"healthyVolunteers":12,"sex":90,"minAge":19,"maxAge":4,"enrollmentInfo":571,"targetDuration":4,"studyType":24,"phases":573,"briefSummary":574,"conditions":575,"keywords":576,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":579,"lastUpdatePostDateStruct":580,"startDateStruct":581,"completionDateStruct":583,"leadSponsor":585,"locationsCount":59},"100576184","phase-3-a-study-to-determine-the-efficacy-of-a-digital-self-management-support-tool-to-improve-the-quality-of-life-during-adjuvant-hormonal-therapy-for-patients-with-early-breast-cancer-100576184","NCT06781996","A Study to Determine the Efficacy of a Digital Self-management Support Tool to Improve the Quality of Life During Adjuvant HOrmonal Therapy for Patients With Early Breast Cancer","Phase III Randomized Controlled Open Label Clinical Trial to Determine the Efficacy of a Digital Self-management Support Tool to Improve the Quality of Life During Adjuvant HOrmonal Therapy for Patients With Early Breast Cancer","HOPE","Inclusion Criteria:\n\n1. Documentation of Disease:\n\n   1. Subjects must have histologically confirmed ER and\u002For PgR positive HR+ invasive BC;\n   2. Subjects must have stage I to III breast cancer and no evidence of distant metastatic or locally recurrent disease;\n\n   NB: Bilateral breast carcinoma is allowed;\n\n   NB: Patients with personal history of previous breast cancer or Ductal Carcinoma in situ (DCIS) are eligible for the protocol;\n2. Indication to receive adjuvant endocrine therapy (tamoxifen or aromatase inhibitors) with or without targeted agents (e.g., CDK 4\u002F6 inhibitors, PARP inhibitors, bisphosphonates);\n3. Prior treatment: Patients must be actively on ET for their breast cancer diagnosis (any type, including either tamoxifen or an aromatase-inhibitor with or without targeted agents) at the time of study enrollment;\n4. Documentation of side effects of ongoing ET: Any endocrine therapy related adverse effects should be reported during treatment with endocrine therapy;\n5. Others:\n\n   1. Age ≥ 18 years;\n   2. ECOG Performance Status 0,1 or 2;\n   3. Patients should possess a smartphone;\n   4. Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed;\n   5. Patient should be able and willing to comply with study visits and procedures as per protocol;\n   6. Patients must be affiliated to a social security system or beneficiary of the same;\n   7. Able to readily read and understand French;\n\nNB: Patients may have breast reconstruction during protocol participation;\n\nNB: Biologic therapy, targeted therapy and bisphosphonates are acceptable during protocol participation;\n\nNB: Male patients can be included in the trial;\n\nNB: Pharmacological or other non-pharmacological interventions for endocrine treatment for adverse effects are accepted at physician discretion.\n\nExclusion Criteria:\n\n1. Severe cognitive impairments or severe psychiatric disorders (assessed by the investigator or mentioned in the medical file of the patient) which in the investigator's opinion would jeopardize compliance with the protocol;\n2. Patient under guardianship or deprived of her\u002Fhis liberty by a judicial or administrative decision or incapable of giving her\u002Fhis consent;\n3. Patients participating at enrollment in a behavioral interventional trial;\n4. Patients suffering from physical related reversible and treatable causes of the entry endocrine therapy-related adverse events (e.g. but not limited to anemia, electrolytes unbalance, infections, renal dysfunction, active metastases hormonal unbalances \\[hypothyroidism, adrenal insufficiency, etc.\\] - according to physician's judgement.",{"count":572,"type":23},180,[400],"Randomized trial that compares a personalized digitally-enabled pathway delivered by a mobile application in addition to standard of care vs. standard of care alone in patients with HR+ early breast cancer reporting endocrine therapy related adverse events.\n\nThe HOPE study is a national, prospective, randomized, open-label trial conducted in France. 180 patients will be randomly assigned 1:1 to receive either 12 weeks of multimodal Resilience© digital companion including education and self-care modules in addition to the standard of care provided by their treating oncologists and supportive care team at their care centers or 12 weeks of standard of care provided by their treating oncologists and supportive care team at their care centers.\n\nData from the literature in oncology trials with Patient-Reported Outcomes suggests that in the absence of double-blind concealment, clinically important differences could still be detected.",[98,34],[504,577,578],"Hormone-receptor positive","endocrine therapy-related adverse events","2025-11-24",{"date":558,"type":51},{"date":582,"type":51},"2025-09-09",{"date":584,"type":23},"2026-12-15",{"name":586,"class":58},"Gustave Roussy, Cancer Campus, Grand Paris",{"id":588,"slug":589,"hasResults":12,"nctId":590,"briefTitle":591,"officialTitle":592,"acronym":4,"eligibilityCriteria":593,"healthyVolunteers":12,"sex":90,"minAge":19,"maxAge":4,"enrollmentInfo":594,"targetDuration":4,"studyType":24,"phases":595,"briefSummary":596,"conditions":597,"keywords":598,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":601,"lastUpdatePostDateStruct":602,"startDateStruct":604,"completionDateStruct":606,"leadSponsor":608,"locationsCount":59},"100608810","feasibility-trial-of-scarwork-for-post-breast-surgery-pain-syndrome-100608810","NCT07206394","Feasibility Trial of ScarWork for Post-breast Surgery Pain Syndrome.","A Feasibility Trial of ScarWork on Post-breast Surgery Pain Syndrome (PBSPS) in Early Stage Breast Cancer Patients.","Inclusion Criteria:\n\n* Over the age of 18\n* Early breast cancer patients who have had breast surgery with curative intent\n* Radiotherapy completed ≥ 6 months previously\n* In remission with no sign of active local disease\n* Registering a score of ≥3 on perceived pain intensity or pain burden on a 10-point numerical rating scale (NRS)\n* English speaking and able to communicate reasonably well\n* Able to give informed consent\n* Willing to attend for regular treatment at RLHIM\n\nExclusion Criteria:\n\n* History of post-breast surgery wound complications\n* History of breast surgery unrelated to breast cancer treatment\n* History of previous ScarWork therapy\n* Diagnosis of lymphoedema\n* Severe co-morbidities or cognitive disability\n* Receiving physiotherapy for post-breast surgery pain syndrome at the time of trial",{"count":218,"type":23},[71],"Breast cancer is the most common cancer in women in the United Kingdom (UK). Most women are treated with a combination of surgery and radiotherapy. While these treatments are effective, they can cause ongoing breast pain for some, which can last months or even years. This long-term pain can have a major impact on quality of life, yet it is often overlooked and not well managed in routine care.\n\nOne in three women may still experience breast pain three years after treatment. The pain can come from scarring, tissue damage, or nerve changes caused by surgery and radiotherapy. Treatments for this pain are limited. Many patients are advised the pain will subside on its own or are given basic painkillers, which sometimes have limited impact.\n\nScarWork is a light-touch manual therapy, developed in the United States and aims to improve the way scars feel and look, reduce pain and tightness, and support healing. Although it has been available in the United Kingdom since 2014, there is very little research into whether ScarWork helps people who experience pain after breast cancer treatment.\n\nThis small study is a first step to see whether ScarWork could be a useful treatment for people who have experience breast pain after surgery and\u002For radiotherapy. The researchers want to know:\n\n* Can this therapy be delivered in an NHS setting?\n* Do people find it helpful?\n* Is it worth doing a larger trial in the future?\n\nParticipants will be randomly placed in one of two groups: one group will continue with usual care, and the other will receive up to five sessions of ScarWork in addition to usual care. Everyone in the study will be asked to complete short questionnaires about their pain and other symptoms, before and after treatment, and again one month later. Participants will also be invited to talk about their experiences in a short phone or online interview.\n\nThis research will help show whether ScarWork might be a useful option for people dealing with breast pain after treatment. It will also help researchers design a larger trial in the future to test ScarWork more fully.",[34],[224,599,600],"ScarWork","feasibility study","2025-09-25",{"date":603,"type":51},"2025-10-03",{"date":605,"type":51},"2025-06-20",{"date":607,"type":23},"2026-06-30",{"name":609,"class":58},"University College London Hospitals",{"id":611,"slug":612,"hasResults":12,"nctId":613,"briefTitle":614,"officialTitle":615,"acronym":616,"eligibilityCriteria":617,"healthyVolunteers":12,"sex":90,"minAge":19,"maxAge":4,"enrollmentInfo":618,"targetDuration":4,"studyType":24,"phases":620,"briefSummary":621,"conditions":622,"keywords":4,"overallStatus":198,"whyStopped":4,"lastUpdateSubmitDate":623,"lastUpdatePostDateStruct":624,"startDateStruct":626,"completionDateStruct":628,"leadSponsor":630,"locationsCount":59},"100604764","phase-3-de-escalation-therapy-in-stage-i-er-positive-breast-cancer-a-non-inferiority-trial-100604764","NCT07153757","De-escalation Therapy in Stage I ER-Positive Breast Cancer: A Non-Inferiority Trial","A Prospective, Randomized, Open-label, Non-inferiority, Phase III Study Evaluating the Efficacy and Safety of 2 to 3 Years of Adjuvant Endocrine De-escalation Therapy for ER-positive\u002FHER2-negative Stage I Breast Cancer","DESCENT","Inclusion Criteria:\n\n* Females aged 18 years or older;\n* Postoperative pathological stage I early breast cancer: histologically confirmed invasive carcinoma with a maximum diameter ≤2 cm and node-negative (N0);\n* Immunohistochemistry (IHC) shows ER-positive (ER ≥50%), HER2 IHC score of 0, 1+, or 2+ with no amplification confirmed by FISH, and Ki-67 ≤20%;\n* Presence of at least one of the following potential low-risk factors:\n\n  1）Tumor size ≤1 cm, 2）21-gene recurrence score \\\u003C11, 3）Fudan digital pathological subtype classified as SNF1, 4）Age ≥65 years;\n* ECOG performance status of 0 or 1;\n* Patients with bilateral synchronous invasive lesions are eligible if both lesions are ER-positive, HER2-negative, and meet the tumor size criteria;\n* Normal major organ function, meeting the following criteria:\n\n  1. Hematological: HB ≥90 g\u002FL (no transfusion within 14 days), ANC ≥1.5×10⁹\u002FL, PLT ≥100×10⁹\u002FL;\n  2. Biochemical: TBIL ≤1.5×ULN, ALT and AST ≤3×ULN, serum Cr ≤1×ULN, and creatinine clearance \\>50 mL\u002Fmin (Cockcroft-Gault formula);\n* Participants voluntarily enroll, sign informed consent, demonstrate good compliance, and cooperate with follow-up.\n\nExclusion Criteria:\n\n* Primary tumor size \\>2 cm in maximum diameter and\u002For axillary lymph node positivity;\n* Prior neoadjuvant therapy, any systemic therapy, or local therapy (except surgery), including chemotherapy, targeted therapy, radiotherapy, or endocrine therapy;\n* Prior adjuvant chemotherapy;\n* Use of CDK4\u002F6 inhibitors in the adjuvant setting;\n* History of other malignancies (except cured basal cell carcinoma or cervical carcinoma in situ);\n* Metastasis at any site;\n* Pregnancy, lactation, or women of childbearing potential unable to use effective contraception;\n* Concurrent participation in other clinical trials;\n* Severe cardiac, pulmonary, hepatic, or renal dysfunction; LVEF \\\u003C50% (by echocardiography); severe cardio-cerebrovascular diseases within 6 months (e.g., unstable angina, chronic heart failure, uncontrolled hypertension \\>150\u002F90 mmHg, myocardial infarction, or stroke); poorly controlled diabetes; severe hypertension;\n* Severe or uncontrolled infections;\n* History of drug abuse or psychiatric disorders;\n* Patients deemed unsuitable for the study by the investigator.",{"count":619,"type":23},2934,[400],"This study is a prospective, randomized, open-label, non-inferiority Phase III clinical trial, planning to enroll 2,934 patients, with a 1:1 allocation to either the conventional endocrine therapy group or the de-escalation therapy group. The aim is to evaluate the safety and efficacy of 2-3 years of de-escalated endocrine therapy in patients with T1N0M0 potentially low-risk breast cancer, respectively.",[34],"2025-09-03",{"date":625,"type":51},"2025-09-04",{"date":627,"type":23},"2025-09-01",{"date":629,"type":23},"2033-09-01",{"name":631,"class":58},"Fudan University",{"id":633,"slug":634,"hasResults":12,"nctId":635,"briefTitle":636,"officialTitle":636,"acronym":637,"eligibilityCriteria":638,"healthyVolunteers":12,"sex":90,"minAge":19,"maxAge":639,"enrollmentInfo":640,"targetDuration":4,"studyType":24,"phases":642,"briefSummary":643,"conditions":644,"keywords":646,"overallStatus":198,"whyStopped":4,"lastUpdateSubmitDate":651,"lastUpdatePostDateStruct":652,"startDateStruct":654,"completionDateStruct":655,"leadSponsor":657,"locationsCount":4},"100598489","the-effect-of-stress-ball-use-on-stress-anxiety-and-vital-signs-in-patients-undergoing-chemotherapy-for-breast-cancer-100598489","NCT07072156","The Effect of Stress Ball Use on Stress, Anxiety, and Vital Signs in Patients Undergoing Chemotherapy for Breast Cancer","Stressball","Inclusion Criteria:\n\n* Stage 2A-2B breast cancer\n* Receiving neoadjuvant chemotherapy\n* On a chemotherapy protocol administered every 21 days\n* Receiving second or subsequent chemotherapy cycle\n* No migraine, vertigo, active nausea, vomiting, or headache\n* No history of seizures\n* No primary or metastatic brain cancer\n* No visual, hearing, or cognitive impairment\n* Age 18 or older\n* No communication barriers\n* Voluntary participation\n\nExclusion Criteria:\n\n* Cancer types other than breast cancer\n* Unilateral or bilateral mastectomy\n* Any condition preventing hand use (e.g., pain, fracture, open wound)\n* IV access in both arms\n* Psychiatric diagnosis\n* Diagnosed anxiety disorder or current anti-anxiety medication use","90 Years",{"count":641,"type":23},50,[71],"AIM This study aims to investigate the effects of stress ball use on stress, anxiety, and vital signs in patients receiving chemotherapy for breast cancer.\n\nMETHOD This study will be conducted with 50 breast cancer patients receiving chemotherapy at the Outpatient Chemotherapy Unit of Rize Training and Research Hospital, using a randomized controlled experimental design. Simple randomization will be used for group assignment. Data will be collected using a Breast Cancer Patient Information Form, Distress Thermometer, and State Anxiety Inventory. It is planned that data will be collected both before and after the chemotherapy session.\n\nORIGINALITY \u002F SCIENTIFIC CONTRIBUTION To date, no study has been found in the literature evaluating the effects of stress balls on stress, anxiety, and vital signs in breast cancer patients undergoing chemotherapy. Therefore, this project is considered original and is expected to contribute to both national and international scientific literature. If successful, the project will provide evidence for a new non-pharmacological intervention that is easy to use during chemotherapy sessions and can help improve patients' stress, anxiety, and vital signs. Patients may experience more comfort and better treatment compliance during chemotherapy.\n\nEXPECTED OUTCOMES It is expected that the use of a stress ball will have a positive effect on reducing stress and anxiety levels and improving vital signs in breast cancer patients receiving chemotherapy.",[645,34],"Chemotherapy",[647,224,648,649,650],"Stress Ball","stress","Anxiety","Vital Signs","2025-07-16",{"date":653,"type":51},"2025-07-18",{"date":53,"type":23},{"date":656,"type":23},"2026-12-01",{"name":658,"class":58},"Ataturk University",{"id":660,"slug":661,"hasResults":12,"nctId":662,"briefTitle":663,"officialTitle":664,"acronym":665,"eligibilityCriteria":666,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":131,"enrollmentInfo":667,"targetDuration":4,"studyType":24,"phases":669,"briefSummary":670,"conditions":671,"keywords":672,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":676,"lastUpdatePostDateStruct":677,"startDateStruct":679,"completionDateStruct":681,"leadSponsor":683,"locationsCount":685},"100592568","the-application-of-huaxi-hole-1-in-reverse-sequence-endoscopic-nipple-sparing-mastectomy-with-direct-to-implant-breast-reconstruction-100592568","NCT06995118","The Application of \"HUAXI Hole 1\" in Reverse-sequence Endoscopic Nipple-sparing Mastectomy With Direct-to-implant Breast Reconstruction","The Application of \"HUAXI Hole 1\" in Reverse-sequence Endoscopic Nipple-sparing Mastectomy With Direct-to-implant Breast Reconstruction: A National Multicenter, Open-Label, Randomized Controlled Trial (HUAXI-h-01)","HUAXI-h-01","Inclusion criteria:\n\n* Female patients aged 18-70 years (inclusive18 and 70 years);\n* Patients eligible for unilateral or bilateral reverse-sequence endoscopic nipple-sparing mastectomy with immediate implant-based breast reconstruction, with concurrent contralateral endoscopic augmentation mammoplasty permitted;\n* Patients with preoperative pathological confirmation of non-specialized breast cancer (e.g., ductal carcinoma in situ, invasive ductal carcinoma, invasive lobular carcinoma) or eligibility for prophylactic mastectomy;\n* For non-specialized breast cancer patients, preoperative tumor size ≤5 cm (post-neoadjuvant chemotherapy if applicable), and no clinical or imaging evidence of invasion to the nipple, skin, subcutaneous fat, chest wall (referring to the bony thorax and intercostal muscles, excluding the pectoralis major and minor muscles) or distant metastasis preoperatively;\n* Patients volunteered to provide informed consent.\n\nExclusion criteria:\n\n* History of open breast surgery within 1 year before this procedure (excluding minimally invasive vacuum-assisted biopsy);\n* Breast cancer diagnosed during pregnancy or lactation;\n* Subnipple-plane scarring with radiotherapy;\n* Metastatic breast cancer (M1);\n* Severe comorbidities precluding general anesthesia or surgery;\n* BMI ≥40 kg\u002Fm²;\n* HbA1c \\>7.5%;\n* Immunodeficiency;\n* Active smoking with ≥20 cigarettes per day\n* Patients with concurrent participation in conflicting clinical trials.",{"count":668,"type":23},337,[71],"This study is a multicenter, open-label, randomized controlled trial. It will prospectively compare outcomes between patients undergoing reverse-sequence endoscopic NSM (R-E-NSM) with direct-to-implant breast reconstruction (DIBR) with the \"HUAXI Hole 1\" versus without the \"HUAXI Hole 1\". The study aims to evaluate differences in operative efficiency, surgical safety, postoperative aesthetics, and oncological safety between the two groups.",[34],[98,673,674,675],"Endoscopic surgery","Nipple-sparing mastectomy","Minimal invasive surgery","2025-06-28",{"date":678,"type":51},"2025-07-02",{"date":680,"type":51},"2025-06-17",{"date":682,"type":23},"2031-12-31",{"name":684,"class":58},"Du Zhenggui",20,{"id":687,"slug":688,"hasResults":12,"nctId":689,"briefTitle":690,"officialTitle":691,"acronym":4,"eligibilityCriteria":692,"healthyVolunteers":12,"sex":90,"minAge":19,"maxAge":131,"enrollmentInfo":693,"targetDuration":4,"studyType":24,"phases":694,"briefSummary":695,"conditions":696,"keywords":697,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":605,"lastUpdatePostDateStruct":702,"startDateStruct":704,"completionDateStruct":706,"leadSponsor":708,"locationsCount":59},"100587345","phase-2-shr-a1811-plus-pertuzumab-in-the-neoadjuvant-treatment-of-her2-positive-bc-100587345","NCT06927180","SHR-A1811 Plus Pertuzumab in the Neoadjuvant Treatment of HER2 Positive BC","SHR-A1811 Plus Pertuzumab in Combination With or Without Albumin-paclitaxel as Neoadjuvant Treatment for Early or Locally Advanced HER2-positive Breast Cancer：A Prospective, Randomized, Open-label, Phase II Trial.","Inclusion Criteria:\n\n* Age: 18-70 years old, ECOG 0-1 point.\n* Clinical T2-T4, with any LN, M0.\n* HER2+, invasive breast cancer confirmed by histopathology;(HER2 positive expression means that there is at least one case of tumor cell immunohistochemical staining intensity of 3+or positive confirmed by fluorescence in situ hybridization \\[FISH\\] in the pathological test\u002Freview of the primary focus conducted by the Pathology Department of the Research Center Hospital).\n* Having clinically measurable lesions: measurable lesions displayed on ultrasound, mammography, or MR (optional) within the first month of randomization.\n* Organ and bone marrow function tests within one month before chemotherapy indicate no contraindications to chemotherapy：Absolute value of neutrophil count ≥ 1.5 × 10\\^9\u002FL; Hemoglobin ≥ 90g\u002FL; Platelet count ≥ 100 × 10\\^9\u002FL; Total bilirubin≤1.5 ULN (upper limit of normal value); Creatinine≤1.5 × ULN; AST\u002FALT ≤ 2.5 × ULN.\n* Cardiac ultrasound: Left ventricular ejection fraction (LVEF ≥ 50%).\n* Women of childbearing age tested negative for serum pregnancy test 7 days before randomization.\n* Sign an informed consent form.\n\nExclusion Criteria:\n\n* Stage IV (metastatic) breast cancer.\n* Has received chemotherapy, endocrine therapy, targeted therapy, reflex therapy, etc. for this disease.\n* The patient has a second primary malignant tumor, except for fully treated skin cancer.\n* The patient had undergone major surgical procedures unrelated to breast cancer within 4 weeks before enrollment, or the patient has not fully recovered from such surgical procedures.\n* The presence of uncontrolled cardiovascular and cerebrovascular disease, including (but not limited to) any of the following within the 6 months prior to the first dose: congestive heart failure (NYHA III or IV), myocardial infarction or cerebral infarction, pulmonary embolism, unstable angina, or arrhythmia requiring treatment at the time of screening; Primary cardiomyopathy (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restricted cardiomyopathy, undefined cardiomyopathy); A clinically significant history of prolonged QTc, grade II type II atrioventricular block or grade III atrioventricular block or QTc interphase (F method) \\> 470 msec (female); Atrial fibrillation (EHRA grade ≥2b); Unmanageable hypertension, which the investigators judged unsuitable for study participation.\n* Due to serious and uncontrollable other medical diseases, researchers believe that there are contraindications to chemotherapy.\n* Individuals with a known history of allergies to the drug components of this protocol;\n* Having a history of immunodeficiency, including HIV testing positive, or suffering from other acquired or congenital immunodeficiency diseases, or having a history of organ transplantation.",{"count":572,"type":23},[26],"The goal of this clinical trial is to evaluate the efficacy and safety of SHR-A1811 plus pertuzumab in combination with or without albumin-paclitaxel neoadjuvant therapy for early or locally advanced HER2-positive breast cancer. The main questions it aims to answer are:\n\n* Does the pCR of SHR-A1811 plus pertuzumab with or without albumin-paclitaxel improve compared to the current standard of treatment?\n* Is the safety of SHR-A1811 plus pertuzumab with or without albumin-paclitaxel better compared to the current standard of treatment? Researchers will compare SHR-A1811+pertuzumab or SHR-A1811+pertuzumab+albumin-paclitaxel to TCbHP to see if SHR-A1811 plus pertuzumab with or without albumin-paclitaxel works to treat early or locally advanced HER2-positive breast cancer.\n\nSubjects will be randomly assigned 1:1:1 to：\n\n* cohort 1：SHR-A1811 combined with pertuzumab for 6 cycles;\n* cohort 2：SHR-A1811 combined with pertuzumab and albumin-paclitaxel for 6 cycles;\n* cohort 3：TCbHP (docetaxel, carboplatin, trastuzumab and pertuzumab) for 6 cycles.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, questionnaires, and scans.",[34],[98,698,699,500,700,701],"HER2-positive Breast Cancer","pathologic complete response","Pertuzumab","Albumin-Paclitaxel",{"date":703,"type":51},"2025-06-23",{"date":705,"type":51},"2025-04-16",{"date":707,"type":23},"2030-12-01",{"name":709,"class":153},"Henan Cancer Hospital"]