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.
1Research sites
750Patients around the world