CRYoablation for Small Tumors As Local Treatment - SIX Trial

Launched by HOSPITAL DO CORACAO · Feb 16, 2025

Keywords

ClinConnect Summary

The CRYoablation for Small Tumors As Local Treatment - SIX Trial is a study that aims to compare a new treatment called cryoablation with traditional breast surgery for early-stage breast cancer. Cryoablation uses extreme cold to destroy cancer cells and may offer a less invasive option for patients. The trial will also look at the costs associated with each treatment to see which one might be more affordable for patients and healthcare systems.

To be eligible for this trial, participants should have a single tumor that is 2.0 cm or smaller and have not received previous treatments for their breast cancer. They must also have a complete medical report that includes specific test results about their cancer. The trial is open to all genders and will include adults aged 65 to 74. Participants can expect to receive care from a team of medical professionals and will be monitored closely throughout the study. Importantly, this trial is not yet recruiting participants, but it represents an exciting opportunity to explore a potentially new way to treat breast cancer.

Gender

ALL

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