Status:
RECRUITING
Ablation Compare With Surgery for Early Breast Cancer
Lead Sponsor:
Peking University People's Hospital
Conditions:
Breast Cancer
Early Stage
Eligibility:
FEMALE
50+ years
Phase:
NA
Brief Summary
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 te...
Eligibility Criteria
Inclusion Criteria:
-
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.
4.Histologic Grade: G1 or G2; ER/PR-positive and HER2-negative. 5.TNM stage: IA. Tumor Size: ≤2 cm; Lymph Node Status: Clinically & radiologically negative (no palpable/imaging-detected axillary involvement).
6.Written consent for clinical trial participation and acceptance of random assignment
Exclusion Criteria:
- 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.
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2031
Estimated Enrollment :
264 Patients enrolled
Trial Details
Trial ID
NCT07484087
Start Date
January 1 2026
End Date
December 31 2031
Last Update
March 19 2026
Active Locations (1)
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1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044