[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646753":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":26,"responsibleParty":41,"collaborators":45,"id":95,"slug":96,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":97,"sex":103,"minAge":104,"maxAge":105,"enrollmentInfo":106,"targetDuration":26,"studyType":109,"phases":110,"briefSummary":112,"conditions":113,"keywords":117,"overallStatus":120,"whyStopped":26,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":26},{"fullName":5,"class":6},"West China Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Surgery Group","EXPERIMENTAL","Patients undergo primary tumor surgery (total mastectomy or breast-conserving surgery with sentinel lymph node biopsy or axillary lymph node dissection, with or without immediate breast reconstruction) within 4 weeks after randomization, followed by continued standard systemic therapy.",[13],"Procedure: Primary Tumor Resection",{"label":15,"type":16,"description":17,"interventionNames":18},"Non-Surgery Group","ACTIVE_COMPARATOR","Patients receive standard systemic therapy alone based on their molecular subtype (e.g., HR+\u002FHER2-: endocrine therapy ± CDK4\u002F6 inhibitor; HER2+: anti-HER2 therapy + chemotherapy; Triple-negative: chemotherapy ± immunotherapy). Palliative local therapy (e.g., radiotherapy) for bone metastases or for managing severe local complications from the primary tumor (e.g., uncontrolled ulceration, bleeding) is permitted but not elective curative-intent primary tumor surgery.",[19],"Other: Standard systemic therapy",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Primary Tumor Resection","Surgical removal of the primary breast tumor. The procedure type (mastectomy or breast-conserving surgery) is determined by tumor size, location, and patient preference, and is performed by experienced breast surgeons following national guidelines. Axillary staging (sentinel node biopsy or dissection) is performed concurrently. Immediate breast reconstruction (prosthesis or autologous tissue) may be performed when indicated.",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Standard systemic therapy","Systemic treatment administered according to the patient's molecular subtype (HR+, HER2+, or Triple-negative) based on Chinese and international clinical guidelines. Regimens include, but are not limited to, endocrine therapy (e.g., letrozole, exemestane) with or without CDK4\u002F6 inhibitors (e.g., palbociclib) for HR+\u002FHER2- disease; anti-HER2 targeted therapy (e.g., trastuzumab, pertuzumab) combined with chemotherapy for HER2+ disease; and chemotherapy (e.g., taxanes, anthracyclines) with or without immunotherapy (e.g., pembrolizumab) for triple-negative disease. All patients with bone metastases routinely receive bone-modifying agents (zoledronic acid or denosumab).",[15],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Zhenggui Du","CONTACT","+86 13880768222","docduzg@163.com",{"name":38,"role":34,"phone":39,"phoneExt":26,"email":40},"Liuying Li","+86 13678020999","lliuying99@163.com",{"type":42,"investigatorFullName":43,"investigatorTitle":44,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Du Zhenggui","Dr.",[46,48,50,53,55,57,59,61,63,65,67,69,71,73,75,77,79,81,83,85,87,89,91,93],{"name":47,"class":6},"The Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine",{"name":49,"class":6},"The First Affiliated Hospital of Zhengzhou University",{"name":51,"class":52},"The Nineth Hospital of Shenzhen, Longgang Center Hospital","UNKNOWN",{"name":54,"class":6},"Baotou Cancer Hospital",{"name":56,"class":6},"Hebei General Hospital",{"name":58,"class":6},"General Hospital of Ningxia Medical University",{"name":60,"class":6},"The First Hospital of Jilin University",{"name":62,"class":6},"Tangshan People's Hospital",{"name":64,"class":6},"Guangdong Women and Children Hospital",{"name":66,"class":52},"Nanchang People's Hospital",{"name":68,"class":6},"Cancer Hospital of Guangxi Medical University",{"name":70,"class":52},"Xinjiang Medical University Cancer Hospital",{"name":72,"class":6},"Anyang Tumor Hospital",{"name":74,"class":6},"The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine",{"name":76,"class":6},"Shanxi Bethune Hospital",{"name":78,"class":6},"Hebei Medical University Fourth Hospital",{"name":80,"class":6},"The Affiliated Hospital of Qingdao University",{"name":82,"class":6},"Suzhou Municipal Hospital",{"name":84,"class":6},"Zhejiang Provincial People's Hospital",{"name":86,"class":6},"Hunan Cancer Hospital",{"name":88,"class":6},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",{"name":90,"class":6},"Shanxi Province Cancer Hospital",{"name":92,"class":52},"The First Hospital of Lanzhou University, Gansu, China",{"name":94,"class":6},"Lanzhou University Second Hospital","100646753","surgery-vs-no-surgery-for-primary-tumor-in-de-novo-stage-iv-breast-cancer-with-solitary-bone-metastases-100646753",false,"NCT07687225","Surgery vs. No Surgery for Primary Tumor in De Novo Stage IV Breast Cancer With Solitary Bone Metastases","A National Multicenter, Prospective, Randomized Controlled Trial Comparing Primary Tumor Surgery Followed by Systemic Therapy With Systemic Therapy Alone in Patients With De Novo Stage IV Breast Cancer and Solitary Bone Metastases","POSITIVE-Bone","Inclusion Criteria:\n\n* Female patients aged 18 to 70 years (inclusive);\n* Histopathologically confirmed (by core needle biopsy) invasive breast cancer;\n* Diagnosed with de novo Stage IV breast cancer with metastases confirmed to be limited to bone;\n* Patients may be enrolled either at initial diagnosis or after receiving first-line systemic therapy;\n* Willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n* Disease progression (per RECIST 1.1 criteria) in the primary tumor, regional lymph nodes, or bone metastases after first-line systemic therapy;\n* Presence of other primary malignancies;\n* Severe comorbidities that would preclude surgery or safe administration of systemic therapy (e.g., severe cardiopulmonary disease, uncontrolled diabetes, long-term smoking history with poor pulmonary function, immunodeficiency);\n* Current participation in another clinical trial that would interfere with the outcomes of this study;\n* Refusal to provide informed consent.","FEMALE","18 Years","70 Years",{"count":107,"type":108},216,"ESTIMATED","INTERVENTIONAL",[111],"NA","This is a national multicenter, prospective, randomized controlled trial. The study aims to compare the 5-year overall survival (OS) between patients receiving primary tumor surgery followed by systemic therapy (surgery group) and those receiving systemic therapy alone (non-surgery group) in patients with de novo Stage IV breast cancer who have solitary bone metastases. Secondary objectives include comparing progression-free survival (PFS), breast cancer-specific survival (BCSS), local control rates, patient-reported outcomes (BREAST-Q, QLQ-C30), safety (surgical complications and systemic therapy toxicities), and cost-effectiveness.",[114,115,116],"Breast Cancer","Stage IV Breast Cancer","Bone Metastases",[114,118,119],"Stage IV","Bone Metastasis","NOT_YET_RECRUITING","2026-06-29",{"date":123,"type":124},"2026-07-07","ACTUAL",{"date":126,"type":108},"2026-09-01",{"date":128,"type":108},"2036-12-31",{"name":5,"class":6}]