NCT06839001 CRYoablation for Small Tumors As Local Treatment - SIX Trial
| NCT ID | NCT06839001 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Hospital do Coracao |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 750 participants |
| Start Date | 2025-03-01 |
| Primary Completion | 2027-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 750 participants in total. It began in 2025-03-01 with a primary completion date of 2027-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Vanessa Monteiro Sanvido, PhD
PRINCIPAL INVESTIGATOR
Research Institute - Hospital do Coracao
Frequently Asked Questions
Who can join the NCT06839001 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06839001 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 750 participants.
Is NCT06839001 currently recruiting?
Yes, NCT06839001 is actively recruiting participants. Contact the research team at dravanessasanvido@gmail.com for enrollment information.
Where is the NCT06839001 trial being conducted?
This trial is being conducted at São Paulo, Brazil, São Paulo, Brazil.
Who is sponsoring the NCT06839001 clinical trial?
NCT06839001 is sponsored by Hospital do Coracao. The principal investigator is Vanessa Monteiro Sanvido, PhD at Research Institute - Hospital do Coracao. The trial plans to enroll 750 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.