Last updated 30 days ago

CRYoablation for Small Tumors As Local Treatment - SIX Trial

750 patients around the world
Available in Brazil
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.
Hospital do Coracao
1Research sites
750Patients around the world

This study is for people with

Breast Cancer

Requirements for the patient

From 18 Years
All Gender

Medical requirements

Unifocal primary invasive breast carcinoma.
Tumor size ≤ 2.0 cm (T1).
Complete pathological report (including results for ER, PR, HER2, Ki-67, and FISH report for the ERBB2 gene, if necessary).
Lesion visible on ultrasound.
Surgical treatment would be the first option, regardless of immunohistochemistry results.
Multifocal or multicentric invasive breast carcinoma.
Ductal carcinoma in situ.
Breast cancer with skin involvement.
Clinically positive axilla (N1, N2 or N3).
Distance from lesion and skin less than 5 mm.
Prior neoadjuvant systemic therapy for breast cancer.
Distant metastasis.

Sites

Instituto do Coração do HCFMUSP
Av. Dr. Enéas Carvalho de Aguiar, 44 - 1° andar, sala 2 - Cerqueira César, São Paulo - SP, CEP: 05403-000
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