Cryoablation for the Treatment of Luminal Early Breast Cancer

What this Trial Is About

Researchers are evaluating cryoablation with liquid nitrogen as a treatment for early-stage luminal breast cancer in postmenopausal women. This study includes women diagnosed with unifocal invasive breast cancer up to 2 cm in size, hormone receptor positive and HER2 negative, without metastatic lymph nodes. The goal is to assess the safety and effectiveness of this treatment approach. Participants will receive cryoablation using the Prosense4 system, where a cryoprobe is inserted into the tumor under local anesthesia and two freezing cycles are performed with a thawing cycle in between. The freezing aims to cover the tumor and a safety margin with ice, monitored by ultrasound to protect surrounding tissue. After cryoablation, patients undergo radio-guided surgical resection to check for any remaining tumor cells. Surgery will also include axillary evaluation, and adjuvant treatments will follow standard clinical practice. During the study, side effects and tolerance of both cryoablation and surgery will be monitored. Researchers will assess cryoablation success rate 30 days after treatment and track complications shortly after the procedure. Patient tolerance will be evaluated 60 days post-cryoablation, and long-term impact will be studied over 36 months. Participants will undergo imaging, biopsies, and clinical assessments as part of their care and monitoring throughout the study.

Luminal Breast Cancer Cryoablation