Ablation Compare With Surgery for Early Breast Cancer

Condition(s) studied

Investigational drug(s) / intervention(s)

breast conserving surgery: 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: 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.

Study 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 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.

This 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:

Baseline clinicopathological characteristics， Surgical details (operation time, intraoperative/postoperative complications, etc.)， Peripheral blood lymphocyte distribution， Treatment efficacy (ipsilateral breast tumor recurrence rate, disease-free survival, overall survival)， Aesthetic outcomes (BREAST-Q score).

Primary endpoint:

Ipsilateral breast local recurrence rate，

Secondary endpoints:

Safety (incidence of adverse events assessed by CTCAE criteria)， Disease-free survival and overall survival， Quality of life assessment (breast satisfaction)，

Exploratory endpoints:

Pathological response of ablated tumor tissue， Correlation analysis between postoperative imaging (MRI/ultrasound) features and recurrence risk.

Eligibility

Primary outcome measure(s)

• 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.

Trial sites (1)

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