[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hormone-receptor-positive\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hormone-receptor-positive":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":5},"100630162","ablation-compare-with-surgery-for-early-breast-cancer-100630162",false,"NCT07484087","Ablation Compare With Surgery for Early Breast Cancer","Prospective, Randomized Controlled Study Comparing Cryo-Thermal Ablation With Traditional Breast-Conserving Surgery in HR-Positive, HER2-Negative Early-Stage Breast Cancer","Inclusion Criteria:\n\n* 1.Age ≥50 Years 2.Unifocal disease (single tumor) confirmed by ultrasound, MRI, or mammography. Ultrasound visibility: Essential for precise intraoperative ablation targeting. 3.Pathologically Confirmed Invasive Ductal Carcinoma (IDC)。Diagnostic Method: Core needle biopsy (CNB) confirming IDC.\n\n  4.Histologic Grade: G1 or G2; ER\u002FPR-positive and HER2-negative. 5.TNM stage: IA. Tumor Size: ≤2 cm; Lymph Node Status: Clinically \\& radiologically negative (no palpable\u002Fimaging-detected axillary involvement).\n\n  6.Written consent for clinical trial participation and acceptance of random assignment\n\nExclusion Criteria:\n\n* 1.Extensive intraductal component (EIC) suggested by imaging or pathology. 2.Invasion of adjacent skin or muscle. 3.Prior anticancer treatment for the current disease, including but not limited to chemotherapy, endocrine therapy, targeted therapy, or immunotherapy. 5.Refusal to undergo breast-conserving surgery. 6.Pregnancy or lactation. 7.Previous radiotherapy to the affected breast or other contraindications to radiotherapy. 8.Concurrent untreated malignancies or severe systemic diseases， 9.Known allergy, intolerance, or contraindications to cryotherapy (e.g., cryoglobulinemia, implanted electronic devices). 10.Inability to comply with follow-up or refusal of adjuvant therapy. 11.Vulnerable populations, including individuals with neurological disorders, cognitive impairment, or critical illness.","FEMALE","50 Years",{"count":19,"type":20},264,"ESTIMATED","INTERVENTIONAL",[23],"NA","Breast-conserving surgery has been widely used in clinical practice, but surgical incisions still impact postoperative patient satisfaction with breast appearance. The development of tumor ablation technologies has introduced new possibilities for breast cancer surgical treatment. The hybrid cryo-thermal ablation system, an advanced minimally invasive tumor treatment device independently developed in China, employs a combined approach of deep cryoablation and high-intensity heating for therapy and has been approved for treating solid tumors, including breast cancer.\n\nThis study is a prospective, single-center, randomized controlled trial. Eligible patients with newly diagnosed early-stage breast cancer treated at the Breast Center of Peking University People's Hospital will be enrolled and randomized in a 1:1 ratio to receive either hybrid cryo-thermal ablation (experimental group) or breast-conserving surgery (control group). Data collected will include:\n\nBaseline clinicopathological characteristics， Surgical details (operation time, intraoperative\u002Fpostoperative complications, etc.)， Peripheral blood lymphocyte distribution， Treatment efficacy (ipsilateral breast tumor recurrence rate, disease-free survival, overall survival)， Aesthetic outcomes (BREAST-Q score).\n\nPrimary endpoint:\n\nIpsilateral breast local recurrence rate，\n\nSecondary endpoints:\n\nSafety (incidence of adverse events assessed by CTCAE criteria)， Disease-free survival and overall survival， Quality of life assessment (breast satisfaction)，\n\nExploratory endpoints:\n\nPathological response of ablated tumor tissue， Correlation analysis between postoperative imaging (MRI\u002Fultrasound) features and recurrence risk.",[26,27,28,29],"Breast Cancer","Early Stage","Hormone Receptor Positive","Ablation","RECRUITING","2026-03-17",{"date":33,"type":34},"2026-03-19","ACTUAL",{"date":36,"type":34},"2026-01-01",{"date":38,"type":20},"2031-12-31",{"name":40,"class":41},"Peking University People's Hospital","OTHER"]