[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ductal-carcinoma-in-situ-dcis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ductal-carcinoma-in-situ-dcis":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,40,59,86],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100651683","phase-3-omission-of-adjuvant-radiotherapy-in-low--and-intermediate-risk-ductal-carcinoma-in-situ-after-breast-conserving-surgery-100651683",false,"NCT07762885","Omission of Adjuvant Radiotherapy in Low- and Intermediate-Risk Ductal Carcinoma In Situ After Breast-Conserving Surgery","A Prospective, Multicenter, Randomized Phase III Non-Inferiority Trial Evaluating Omission of Adjuvant Radiotherapy in Low- and Intermediate-Risk ER-Positive HER2-Negative Ductal Carcinoma In Situ Following Breast-Conserving Surgery","Inclusion Criteria:\n\n1. Female patients aged ≥40 years；\n2. Histologically confirmed low- or intermediate-grade ductal carcinoma in situ (DCIS) without invasive carcinoma, including incidental DCIS identified within benign breast lesions；\n3. Tumor size ≤2.5 cm on final pathology；\n4. Negative surgical margins ≥3 mm, including margins obtained after re-excision；\n5. Estrogen receptor-positive disease (ER ≥10%) with planned endocrine therapy using tamoxifen；\n6. Unifocal lesion；\n7. Absence of comedo necrosis；\n8. Screen-detected disease without bloody nipple discharge or palpable mass；\n9. Clinically node-negative disease；\n10. Patients randomized to the radiotherapy arm must initiate radiotherapy within 3 months after surgery；\n11. Central pathology review by the participating institution required；\n12. Ability to understand and willingness to sign written informed consent.\n\nExclusion Criteria:\n\n1. Known BRCA1 or BRCA2 germline mutation carriers (genetic testing not mandatory)；\n2. Contraindications to radiotherapy, including active connective tissue disease；\n3. Active infection requiring systemic treatment；\n4. Bilateral breast cancer or prior contralateral breast cancer；\n5. Severe uncontrolled comorbidities, including significant cardiac, pulmonary, hepatic, renal, hematologic, or psychiatric disorders；\n6. History of other malignancies, including thyroid cancer, except adequately treated basal cell carcinoma of the skin or cervical carcinoma in situ；\n7. Prior thoracic radiotherapy；\n8. Pregnant or breastfeeding patients；\n9. Estimated life expectancy ≤5 years；\n10. Poor compliance or inability to adhere to study follow-up requirements.","FEMALE","40 Years",{"count":19,"type":20},636,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","This is a prospective, multicenter, randomized, open-label, phase III non-inferiority trial designed to evaluate whether omission of postoperative radiotherapy is clinically acceptable in patients with low- and intermediate-risk ductal carcinoma in situ (DCIS) following breast-conserving surgery. Eligible patients include women aged ≥40 years with ER-positive, low- or intermediate-grade DCIS, tumor size ≤2.5 cm, negative surgical margins ≥3 mm, absence of comedo necrosis, and screen-detected unifocal disease. Patients will be randomized to postoperative observation alone or adjuvant radiotherapy. The primary endpoint is 5-year ipsilateral breast tumor recurrence (IBTR).",[26],"Ductal Carcinoma In Situ, DCIS","RECRUITING","2026-08-09",{"date":30,"type":31},"2026-08-13","ACTUAL",{"date":33,"type":31},"2026-07-01",{"date":35,"type":20},"2036-06",{"name":37,"class":38},"Fudan University","OTHER",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":53,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":39},"100651672","phase-2-omission-of-adjuvant-radiotherapy-in-young-low-risk-ductal-carcinoma-in-situ-following-breast-conserving-surgery-100651672","NCT07762924","Omission of Adjuvant Radiotherapy in Young Low-Risk Ductal Carcinoma In Situ Following Breast-Conserving Surgery","A Single-Center Prospective Phase II Study Evaluating the Safety of Omission of Adjuvant Radiotherapy in Young Patients With Low-Risk Ductal Carcinoma In Situ After Breast-Conserving Surgery","Inclusion Criteria:\n\n1. Female patients aged \\\u003C40 years；\n2. Histologically confirmed low- or intermediate-grade ductal carcinoma in situ (DCIS) without invasive carcinoma, including incidental DCIS identified within benign breast lesions；\n3. Tumor size ≤1 cm on final pathology；\n4. Negative surgical margins ≥3 mm, including margins obtained after re-excision；\n5. Unifocal lesion；\n6. Absence of comedo necrosis；\n7. Screen-detected disease without bloody nipple discharge or palpable mass；\n8. Clinically node-negative disease；\n9. Central pathology review by the participating institution required；\n10. Ability to understand and willingness to sign written informed consent.\n\nExclusion Criteria:\n\n1. Known BRCA1, BRCA2, or TP53 germline mutation carriers (genetic testing not mandatory)；\n2. Bilateral breast cancer or prior contralateral breast cancer；\n3. Severe uncontrolled comorbidities, including significant cardiac, pulmonary, hepatic, renal, hematologic, or psychiatric disorders；\n4. History of other malignancies, including thyroid cancer, except adequately treated basal cell carcinoma of the skin or cervical carcinoma in situ；\n5. Pregnant or breastfeeding patients；\n6. Estimated life expectancy ≤5 years；\n7. Poor compliance or inability to adhere to study follow-up requirements.",{"count":48,"type":20},234,[50],"PHASE2","This is a single-center, prospective phase II clinical study designed to evaluate whether omission of postoperative radiotherapy is clinically acceptable in young patients with low-risk ductal carcinoma in situ (DCIS) following breast-conserving surgery. Eligible patients include women younger than 40 years with low- or intermediate-grade DCIS, tumor size ≤1 cm, negative surgical margins ≥3 mm, absence of comedo necrosis, and unifocal screen-detected disease. Patients in the radiotherapy omission cohort will undergo close surveillance after surgery, with endocrine therapy permitted according to physician discretion. The primary endpoint is 5-year ipsilateral breast tumor recurrence (IBTR).",[26],{"date":30,"type":31},{"date":55,"type":20},"2026-09-01",{"date":57,"type":20},"2037-02",{"name":37,"class":38},{"id":60,"slug":61,"hasResults":11,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":67,"targetDuration":4,"studyType":21,"phases":69,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":39},"100647659","personalized-prone-immobilization-for-accelerated-partial-breast-radiotherapy-100647659","NCT07711847","Personalized Prone Immobilization for Accelerated Partial Breast Radiotherapy","Accelerated Partial Breast Radiotherapy Study of a Personalized Holder for Prone Breast Immobilization to Enhance Local Delivery","SHIELD","INCLUSION Criteria:\n\n* Written informed consent according to ICH\u002FGCP regulations before registration and prior to any study-specific procedures\n* Upfront breast conservative surgery\n* Radiotherapy planned within 12 weeks after surgery\n* ECOG\u002FWHO performance status ≤2\n* Age ≥40 year\n\nFor invasive breast cancer only:\n\n* Staging pT1-T2, N0M0 (Tumor size ≤3 cm)\n* If no sentinel lymph node biopsy performed, patient must be clinically N0\n* Negative margins (no tumor on ink)\n\nFor ductal carcinoma in situ only:\n\n* Staging pTis (tumor size ≤3 cm)\n* Negative margins (≥2 mm)\n\nEXCLUSION Criteria:\n\n* Patient of male sex\n* Inability to obtain informed consent or adhere to the CIP\n* Breast skin damage that could prevent VENUS SHELL™ usage according to protocol timeline (e.g. presence of any skin or soft tissue wound that failed to show evidence of progression towards healing, clinical signs of active infection at or immediately adjacent to the intended intervention site, etc.)\n* Known germline BRCA1\u002F2 mutation\n* Unable to lay prone\n* Unable to undergo imaging by CT scan\n* Documented hypersensitivity or allergy to medical plasters, acrylonitrile butadiene styrene\n* Any serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may affect patient compliance or place the patient at high risk within the study.\n* Pregnancy or breast feeding\n* Claustrophobia\n* Patient with a body weight exceeding 120 kg\n* Patient with pendulous breasts that come into contact with the CT table, preventing adequate space for shell usage\n* Presence of any cardiac implantable electronic device (CIED), including but not limited to a pacemaker, implantable cardioverter-defibrillator (ICD), cardiac resynchronization therapy (CRT) device, or other electronically active implant.",{"count":68,"type":20},30,[70],"NA","The goal of this clinical trial is to find out whether using a personalized breast holder (called VENUS SHELL™) can improve positioning and patient comfort during prone radiotherapy (radiotherapy given while the patient lies on her stomach).\n\nThe main goals of the study are:\n\n* To confirm that using the VENUS SHELL™ is safe and effective\n* To assess whether the VENUS SHELL™ helps deliver accurate radiation treatment in a faster and more comfortable way\n\nParticipants will:\n\n* Attend a study visit before radiotherapy to have a breast surface scan (no radiation) and enable the production of their personalized VENUS SHELL™\n* Use their VENUS SHELL™ during radiotherapy planning and treatment\n* Be asked to complete questionnaires about their comfort",[73,26],"Invasive Breast Cancer Early Stages",[75],"APBI","2026-07-14",{"date":78,"type":31},"2026-07-17",{"date":80,"type":20},"2026-07",{"date":82,"type":20},"2027-07",{"name":84,"class":85},"HeroSupport SA","INDUSTRY",{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":16,"minAge":94,"maxAge":4,"enrollmentInfo":95,"targetDuration":4,"studyType":21,"phases":97,"briefSummary":98,"conditions":99,"keywords":102,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":39},"100634780","areola-preservation-in-nsm-with-nipple-involvement-100634780","NCT07544134","Areola Preservation in NSM With Nipple Involvement","Oncologic Safety and Aesthetic Outcomes of Areola Preservation With Simultaneous Nipple Reconstruction in Nipple-Sparing Mastectomy With Intraoperative Nipple Involvement: A Single-Center, Prospective, Exploratory Study","APRESERVE-1","Inclusion Criteria:\n\n1. Female, age ≥ 18 years.\n2. Pathologically confirmed primary invasive breast carcinoma or ductal carcinoma in situ (DCIS).\n3. Clinical tumor stage cTis-2, N0-2, M0 (AJCC 8th Edition).\n4. Planned for therapeutic nipple-sparing mastectomy (NSM) with immediate reconstruction.\n5. Intraoperative frozen section confirms involvement of the nipple core tissue by invasive carcinoma or DCIS.\n6. ECOG performance status 0-1.\n7. Willing and voluntarily provide written informed consent.\n\nExclusion Criteria:\n\n1. Clinical or radiological suspicion of areola or skin involvement.\n2. Inflammatory breast cancer.\n3. Pregnancy or lactation.\n4. Any severe medical or psychiatric condition that, in the investigator's judgment, would preclude safe participation or compliance.\n5. Severe uncontrolled comorbidities with a life expectancy of less than 5 years.","18 Years",{"count":96,"type":20},40,[70],"Background:\n\nDuring nipple-sparing mastectomy (a surgery that removes breast tissue but keeps the nipple and areola), doctors test the tissue behind the nipple right away. If cancer cells are found in this nipple tissue, current guidelines say the entire nipple and areola must be removed. However, research suggests that when the nipple is involved, the surrounding pigmented skin (the areola) is very rarely affected by cancer. Removing it might be unnecessary and leads to a worse cosmetic outcome, which can impact a woman's self-image and quality of life. Currently, there is no prospective study to guide whether the areola can be safely preserved in this specific situation.\n\nPurpose:\n\nThis is a pilot study that aims to explore the feasibility, safety, and early outcomes of a new surgical procedure: preserving the areola and performing immediate nipple reconstruction when cancer is found in the nipple during surgery.\n\nStudy Plan:\n\nThis is a single-arm, single-center, prospective, exploratory study. Women with early-stage breast cancer who are scheduled for a nipple-sparing mastectomy will be invited. Only if cancer is confirmed in the nipple during their surgery will they be enrolled into the single test group. In this group:\n\nThe nipple is removed.\n\nA small ring of tissue from under the areola is tested immediately (second frozen section). If this ring shows no cancer, the areola skin is preserved.\n\nA new nipple is created during the same operation using a local skin flap technique (purse-string suture).\n\nAll patients will have immediate breast reconstruction.\n\nWe plan to include about 40-60 patients at one hospital. Patients will be closely followed for 3 years with regular check-ups and scans to monitor for any cancer recurrence or complications.\n\nWhat We Will Measure (Exploratory Endpoints):\n\nSafety \\& Feasibility: The success rate of areola preservation (based on negative second frozen section), surgical complication rates (e.g., infection, tissue necrosis).\n\nEarly Effectiveness: The rate of cancer returning in the breast\u002Fchest wall area within 3 years (local recurrence).\n\nPatient-Reported Outcomes: Patient satisfaction with their breasts and well-being, measured by the BREAST-Q questionnaire before and after surgery.\n\nWhy This Study is Important:\n\nThis is the first prospective study to systematically evaluate this new surgical approach. The results will provide crucial preliminary data on safety and early outcomes. If the findings are promising, they will form the foundation for designing a larger, controlled trial in the future. Ultimately, this research could lead to a new option that offers women better cosmetic results and improved quality of life after mastectomy.",[100,26,101],"Breast Cancer","Invasive Breast Carcinoma",[100,103,104,105,106],"Nipple Sparing Mastectomy","NSM","Nipple Areola Complex","Nipple Reconstruction","NOT_YET_RECRUITING","2026-04-19",{"date":110,"type":31},"2026-04-22",{"date":112,"type":20},"2026-05-01",{"date":114,"type":20},"2030-01-15",{"name":116,"class":38},"Second Affiliated Hospital, School of Medicine, Zhejiang University"]