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

Ablation Compare With Surgery for Early Breast Cancer | DecenTrialz