Cryoablation for small breast tumors (SIX)
Official title: Cryoablation Versus Breast Surgery in the Local Treatment of Early-Stage Breast Cancer - Six Trial
Run by Hospital do Coracao · NCT06839001 · Data updated 2026-11-12
This study will test whether cryoablation works as well as standard breast surgery for people with small (≤2.0 cm), unifocal early-stage breast cancer and will compare direct costs over one year.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 750 (estimated) |
| Sponsor | Hospital do Coracao Academic / other |
| Locations | 2 sites (São Paulo, São Paulo and 1 other locations) |
| Status | Recruiting |
| Started | March 1, 2025 |
| Main results expected | March 1, 2027 |
| Study ends | March 1, 2030 |
| Registry record updated | June 26, 2025 |
| Trial ID | NCT06839001 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people with a single invasive breast tumor ≤2.0 cm that is visible on ultrasound, clinically node-negative, without skin involvement, no prior neoadjuvant therapy, and who would otherwise be surgical candidates.
✕Probably not a fit
Patients with multifocal or multicentric disease, ductal carcinoma in situ alone, clinically positive axilla, tumor-to-skin distance <5 mm, prior neoadjuvant therapy, or distant metastases are unlikely to benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 3 randomized non-inferiority trial comparing percutaneous cryoablation to standard breast surgery (lumpectomy or mastectomy) for T1N0M0 unifocal invasive breast cancer. The primary endpoint is locoregional control and non-inferiority of cryoablation over five years, with a one-year cost-minimization analysis of direct treatment costs. Secondary measures include one-year locoregional recurrence, five-year disease-free and overall survival, serial circulating tumor cell (CTC) monitoring, patient satisfaction (Breast-Q) at one year, and quality of life (EQ-5D). The protocol incorporates a de-escalated approach by omitting sentinel lymph node biopsy when appropriate, using ultrahypofractionated radiotherapy, and applying liquid biopsy for monitoring.
Why it matters
Potential benefit: If successful, cryoablation could offer a less invasive, outpatient alternative to surgery with faster recovery and lower direct costs while preserving similar oncologic outcomes.
How similar studies have gone: Small nonrandomized and pilot studies have reported promising local control with cryoablation for small breast cancers, but randomized Phase 3 evidence comparing it directly to surgery is limited.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Research Institute - Hospital do Coracao
São Paulo, São Paulo, Brazil Recruiting -
Research Institute - Hospital do Coracao
São Paulo, São Paulo, Brazil Not yet recruiting
Study contacts
- Principal investigator: Vanessa Monteiro Sanvido, PhD — Research Institute - Hospital do Coracao
- Study coordinator: Vanessa Monteiro Sanvido, PhD, Professor
- Email: dravanessasanvido@gmail.com
- Phone: +55 11 5576484
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
AI-powered mobile app to support chemotherapy for breast cancer
A mobile app in Arabic uses AI to help women undergoing chemotherapy see if it can improve symptom control and medication adherence compared with standard care.
-
Predicting outcomes for advanced breast cancer patients treated with CDK4/6 inhibitors and endocrine therapy
This study is trying to see how well different CDK4/6 inhibitors combined with hormone therapy work for people with advanced breast cancer and how safe they are.
-
Using tart cherry juice to prevent nerve damage from chemotherapy in breast cancer patients
This study is testing if drinking tart cherry juice can help prevent nerve damage in breast cancer patients receiving chemotherapy.
-
Oral MBQ-167 treatment for advanced breast cancer
This study is testing a new oral medication called MBQ-167 to see if it can help people with advanced breast cancer who haven't had success with other treatments.
-
Evaluating Bria-IMT with Checkpoint Inhibitor for Advanced Metastatic Breast Cancer
This study is testing if a new treatment combining Bria-IMT with a checkpoint inhibitor can help people with advanced metastatic breast cancer live longer compared to other treatments their doctors might choose.
-
Precision therapy for advanced breast cancer patients
This study is testing different targeted treatments for patients with advanced breast cancer who have already tried certain medications, to see if personalized options can help them feel better.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.