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CRYoablation for Small Tumors As Local Treatment - SIX Trial

RECRUITINGPhase 3Sponsored by Hospital do Coracao
Actively Recruiting
PhasePhase 3
SponsorHospital do Coracao
Started2025-03-01
Est. completion2027-03-01
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06839001

Summary

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions3

Breast CancerBreast NeoplasmCancer

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