CRYoablation for Small Tumors As Local Treatment - SIX Trial

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.

Trial Details

NCT ID
NCT06839001
Phase
PHASE3
Sponsor
Hospital do Coracao
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • cryoablation
  • Breast Surgery (Lumpectomy or Mastectomy)
Locations (sample)
  • São Paulo, São Paulo, Brazil|-23.5475,-46.63611
  • São Paulo, São Paulo, Brazil|-23.5475,-46.63611

Key Eligibility 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

For full eligibility, visit ClinicalTrials.gov.

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