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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 264 (estimated)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: Female
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer
• Early Stage
• Hormone Receptor Positive
• Ablation

Interventions

Type	Name	Description
PROCEDURE	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.
PROCEDURE	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.

Timeline

• Start date: 2026-01-01
• Primary completion: 2028-12-31
• Completion: 2031-12-31
• First posted: 2026-03-19
• Last updated: 2026-03-19

Locations

1 site across 1 country: China