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CRYoablation for Small Tumors As Local Treatment - SIX Trial

RecruitingPhase 3Ages 18 Years - anyAllHospital do Coracao
NCT06839001 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • cryoablation
  • Breast Surgery (Lumpectomy or Mastectomy)
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Where

2 sites
Research Institute - Hospital do Coracao
São Paulo, Brazil
Research Institute - Hospital do Coracao
São Paulo, Brazil
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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