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Ablation Compare With Surgery for Early Breast Cancer

NCT07484087 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 264

Last updated 2026-03-19

No results posted yet for this 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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Peking University People's Hospital

    lead OTHER

Principal Investigators

  • shu wang, doctor · Peking University People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2028-12-31
Completion
2031-12-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07484087 on ClinicalTrials.gov