CRYoablation for Small Tumors As Local Treatment - SIX Trial
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital do Coracao
About this 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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Multifocal or multicentric invasive breast carcinoma
Ductal carcinoma in situ
Breast cancer with skin involvement
Clinically positive axilla (N1, N2 or N3)
Trial design
Treatments tested in this trial
- cryoablation
- Breast Surgery (Lumpectomy or Mastectomy)
Treatment groups
750 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov