Prospective, Randomized Controlled Study Comparing Cryo-Thermal Ablation With Traditional Breast-Conserving Surgery in HR-Positive, HER2-Negative Early-Stage Breast Cancer

What this Trial Is About

Researchers are evaluating the use of a hybrid cryo-thermal ablation system compared to traditional breast-conserving surgery for women diagnosed with early-stage, hormone receptor-positive, HER2-negative breast cancer. This prospective, randomized controlled trial aims to assess differences in tumor recurrence, treatment safety, and patient quality of life after these treatments. The study involves patients newly diagnosed and treated at a single center in China using an advanced minimally invasive device combining freezing and heating for tumor destruction. Participants will be randomly assigned to receive either the hybrid cryo-thermal ablation or standard breast-conserving surgery. The ablation procedure includes ultrasound-guided insertion of a probe into the tumor, followed by cycles of freezing and heating to destroy the tumor tissue. The surgery group undergoes breast-conserving surgery following Chinese clinical guidelines to remove the tumor with negative margins. Both treatments intend to fully cover the tumor area, ensuring oncological safety. During the trial, participants will be monitored for surgical details, complications, immune cell changes, and treatment efficacy including local recurrence rates and survival outcomes over several years. Aesthetic results and quality of life will also be evaluated using patient surveys. Imaging and pathological analyses will explore tumor response and potential links between imaging features and recurrence risk. The study includes follow-up assessments and safety evaluations up to five years after treatment to understand long-term outcomes.

Ablation Compare With Surgery for Early Breast Cancer