Ablation Compare With Surgery for Early Breast Cancer

• breast conserving surgery (Procedure): According to the 《Chinese Breast Cancer Diagnosis and Treatment Guidelines》, standard breast-conserving surgery (BCS) was performed, with pathologically confirmed negative margins.
• cryo-thermal ablation (Procedure): Real-time ultrasound imaging to confirm tumor size and shape. Mark the ablation target zone, including the 5-mm peripheral margin. Ablation Procedure Step 1: Probe Insertion Under ultrasound guidance, insert the cryo-thermal ablation probe into the tumor center. Step 2: Dual-Cycle Ablation (Freeze-Heating-Freeze) First Freeze Cycle: Duration: 10-15 minutes. Temperature: Rapid cooling to -196°C (liquid nitrogen). Endpoint: Ice ball fully envelops the tumor + 5-mm margin (confirmed by ultrasound). Heating Phase: Temperature: Rapid heating to 80°C. Duration: 5-10 minutes (thawing and thermal damage enhancement). Second Freeze Cycle: Repeat freezing to ensure complete tumor destruction.

Primary outcomes

• Ipsilateral Breast Tumor Recurrence Rate [3 years]: The time from the date of surgery to the date of ipsilateral breast tumor recurrence, with the occurrence of ipsilateral breast tumor recurrence as the event.

Secondary outcomes

• complication rate [3 months]: intraoperative Complications: Bleeding, vascular/nerve injury. Postoperative Complications: Infection, hematoma, skin frostbite (cryoablation-specific), breast deformity, sensory abnormalities. Grading: Recorded per CTCAE v5.0 (e.g., Grade 1: mild; Grade 3: severe requiring intervention).
• Disease-Free Survival [3 years]: Time from study enrollment to the first occurrence of: Ipsilateral locoregional recurrence. Contralateral breast cancer. Distant metastasis, Death from any cause.
• overall survival [5 years]: Time from study enrollment to death from any cause.
• Quality of Life (QoL) [1 year]: Tool: BREAST-Q (validated patient-reported outcome measure) Phychosocial well-being scale, satisfaction with breasts scale Domains Evaluated: Breast aesthetics (appearance/satisfaction post-treatment). Psychosocial/sexual well-being. Physical discomfort.

Sex: Female, ages: 50 Years to any

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.

• shu wang, doctor, Study director, Peking University People's Hospital