NCT06839001

CRYoablation for Small Tumors As Local Treatment - SIX Trial

Cryoablation Versus Breast Surgery in the Local Treatment of Early-Stage Breast Cancer - Six Trial

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 750 (estimated)
• Sponsor: Hospital do Coracao · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To demonstrate the non-inferiority of cryoablation compared to breast surgery for the local treatment of early-stage breast cancer and to conduct a cost-minimization analysis comparing direct costs between treatments.

Detailed description

This study compares cryoablation with breast surgery for the treatment of early-stage breast cancer (T1N0M0), evaluating locoregional recurrence, cost-minimization, and disease-free survival. The primary objective is to demonstrate the non-inferiority of cryoablation compared to breast surgery for local treatment of early-stage breast cancer over five years, as well as to perform a cost-minimization analysis to compare the direct costs of both treatments over one year. The secondary objectives include assessing locoregional recurrence at one year, evaluating disease-free survival and overall survival over five years, analyzing circulating tumor cells (CTCs) as prognostic factors and for monitoring cryoablation at baseline (study inclusion), six months, and twelve months, measuring patient satisfaction one year after randomization using the Breast-Q questionnaire, and assessing quality of life using the EQ-5D questionnaire. Cryoablation is a nonsurgical, minimally invasive technique that destroys tumor tissue through cyclic freezing and thawing using cryoprobes. This process induces cellular death without requiring hospitalization, allowing for faster recovery. Additionally, the study incorporates a de-escalated and personalized approach to breast cancer treatment by omitting sentinel lymph node biopsy, integrating ultrahypofractionated radiotherapy, and utilizing liquid biopsy.

Conditions

• Breast Cancer
• Breast Neoplasm

Interventions

Type	Name	Description
PROCEDURE	cryoablation	Two devices can be used to perform cryoablation: Cryocare® and ProSense IceCure®: * Cryocare® - This procedure utilizes two types of gases: argon gas for freezing and helium gas for thawing. * ProSense IceCure® - This procedure uses extremely low temperatures generated by liquid nitrogen (LN2) to freeze and destroy the target tissue, without the need for an additional gas.
PROCEDURE	Breast Surgery (Lumpectomy or Mastectomy)	Surgery can be performed as lumpectomy or mastectomy and axillary surgery, preferably sentinel lymph node biopsy.

Timeline

• Start date: 2025-03-01
• Primary completion: 2027-03-01
• Completion: 2030-03-01
• First posted: 2025-02-21
• Last updated: 2025-06-26

Locations

2 sites across 1 country: Brazil