Clinical trial NCT06839001: CRYoablation for Small Tumors As Local Treatment - SIX Trial
Official title: Cryoablation Versus Breast Surgery in the Local Treatment of Early-Stage Breast Cancer - Six Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Breast Cancer
Breast Neoplasm
Keywords: Breast Cancer
Minimally Invasive Surgical Procedures
Cryoablation
Locoregional Recurrence
Cost-Minimization Analysis
Lead sponsor: Hospital do Coracao
Sponsor class: OTHER
First posted: 2025-02-21
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The initial 750 participants will be randomized in a 1:1 manner to either cryoablation or breast surgery.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Locoregional recurrence (LRR)
timeFrame: 5 years
measure: Cost-minimization
timeFrame: 1 year
Secondary outcomes:
measure: Locoregional recurrence (LRR)
timeFrame: 1 year
measure: Disease-free survival (DFS)
timeFrame: 5 years
measure: Overall Survival (OS)
timeFrame: 5 years
measure: Circulating tumor cells (CTCs)
timeFrame: 1 year
measure: Patient satisfaction
timeFrame: 1 month
measure: EQ-5D questionnaire
timeFrame: 1 year
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Research Institute - Hospital do Coracao
state: SP
Study officials:
affiliation: Research Institute - Hospital do Coracao
name: Vanessa Monteiro Sanvido, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Research Institute - Hospital do Coracao
name: Afonso Celso Pinto Nazário, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Research Institute - Hospital do Coracao
name: Alexandre Biasi Cavalcante, PhD
role: STUDY_DIRECTOR
References: