CRYoablation for Small Tumors As Local Treatment - SIX Trial
Recruiting · NCT06839001 · Interventional (participants receive a specific treatment) · Lead sponsor: Hospital do Coracao
View the official record on ClinicalTrials.gov →Interventions studied
Breast Surgery (Lumpectomy or Mastectomy)cryoablation
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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 is running
2 locations listed.
- Research Institute - Hospital do Coracao - São Paulo, São Paulo, Brazil
- Research Institute - Hospital do Coracao - São Paulo, São Paulo, Brazil