Actively Recruiting
CRYoablation for Small Tumors As Local Treatment - SIX Trial
Led by Hospital do Coracao · Updated on 2025-06-26
750
Participants Needed
2
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
CRYoablation for Small Tumors As Local Treatment - SIX Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Unifocal primary invasive breast carcinoma
- Tumor size 2.0 cm or smaller (T1)
- Complete pathological report including ER, PR, HER2, Ki-67, and FISH for ERBB2 if needed
- Lesion must be visible on ultrasound
- Surgical treatment would be the first option regardless of immunohistochemistry results
You will not qualify if you...
- Multifocal or multicentric invasive breast carcinoma
- Ductal carcinoma in situ
- Breast cancer involving the skin
- Clinically positive axilla (N1, N2, or N3)
- Distance from lesion to skin less than 5 mm
- Prior neoadjuvant systemic therapy for breast cancer
- Presence of distant metastasis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Research Institute - Hospital do Coracao
São Paulo, São Paulo, Brazil, 04004-030
Not Yet Recruiting
2
Research Institute - Hospital do Coracao
São Paulo, São Paulo, Brazil, 04041-004
Actively Recruiting
Research Team
V
Vanessa Monteiro Sanvido, PhD, Professor
CONTACT
A
Afonso Celso Pinto Nazário, PhD, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here