RecruitingPhase 3NCT06839001

CRYoablation for Small Tumors As Local Treatment - SIX Trial

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


Sponsor

Hospital do Coracao

Enrollment

750 participants

Start Date

Mar 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing cryoablation — a procedure that freezes and destroys tumor tissue — as an alternative to surgery for small breast cancers. Instead of removing the tumor surgically, a needle is inserted to freeze the cancer in place. The study aims to see if this approach is as safe and effective as standard surgery. **You may be eligible if...** - You have been diagnosed with early-stage invasive breast cancer in a single location - Your tumor is 2 cm or smaller (T1 stage) - Your tumor is visible on ultrasound - You have a complete pathology report including hormone receptor and HER2 status - Surgery would have been recommended as your primary treatment **You may NOT be eligible if...** - You have cancer in multiple areas of the breast (multifocal or multicentric) - Your cancer involves the skin - Lymph nodes in your armpit are clearly affected - The tumor is less than 5 mm from the skin surface - You have already received chemotherapy or other cancer treatment before surgery - Your cancer has spread to other parts of the body Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREcryoablation

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.

PROCEDUREBreast Surgery (Lumpectomy or Mastectomy)

Surgery can be performed as lumpectomy or mastectomy and axillary surgery, preferably sentinel lymph node biopsy.


Locations(2)

Research Institute - Hospital do Coracao

São Paulo, São Paulo, Brazil

Research Institute - Hospital do Coracao

São Paulo, São Paulo, Brazil

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NCT06839001


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