Status:

UNKNOWN

FreezIng bReaST Cancer in Brazil: a Before-after Study

Lead Sponsor:

Hospital do Coracao

Conditions:

Breast Cancer

Breast Neoplasms

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

Image-guided tumor ablation is a non-surgical, minimally invasive therapy available for local therapy of some carcinomas as an alternative to surgical treatment. This study assesses whether cryoablati...

Detailed Description

Purpose: To evaluate the effectiveness of cryoablation in the local treatment of breast cancer, through the absence of neoplastic cells (invasive or in situ). Outline 1. Core biopsy 2. Mammogram 3. ...

Eligibility Criteria

Inclusion

  • Unifocal primary invasive breast carcinoma
  • Pathological report should be complete (with the result of ER, PR , HER2, KI67 and FISH report of ERBB2 gene if necessary)
  • Maximum tumor size ≤2.5 cm in its greatest diameter
  • Ultrasound visible lesion

Exclusion

  • 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

Key Trial Info

Start Date :

September 15 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

July 15 2024

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT05398497

Start Date

September 15 2022

End Date

July 15 2024

Last Update

September 21 2022

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Hcor

São Paulo, São Paulo, Brazil, 04004-030