CRYoablation for Small Tumors As Local Treatment - SIX Trial
Cryoablation Versus Breast Surgery in the Local Treatment of Early-Stage Breast Cancer - Six Trial
Hospital do Coracao
750 participants
Mar 1, 2025
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
Inclusion Criteria5
- 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 Criteria7
- 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
Interventions
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.
Surgery can be performed as lumpectomy or mastectomy and axillary surgery, preferably sentinel lymph node biopsy.
Locations(2)
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NCT06839001