ClinicalTrials.Veeva

Menu

FreezIng bReaST Cancer in Brazil: a Before-after Study (FIRST)

H

Hospital do Coracao

Status

Not yet enrolling

Conditions

Breast Cancer
Breast Neoplasms

Treatments

Device: Cryoablation

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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 cryoablation can be used as an alternative to surgery in cases of early invasive breast carcinoma.

Full 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. Magnetic resonance imaging
  4. Ultrasound
  5. Tumor Cryoablation
  6. Mammogram (post-cryoablation)
  7. Magnetic resonance imaging (post-cryoablation)
  8. Ultrasound (post-cryoablation)
  9. Surgery
  10. Evaluation of outcomes

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

Early stage breast cancer up to 2.5 cm
Experimental group
Description:
Patients treated with Cryocare SL followed by traditional surgery, radiotherapy and adjuvant systemic therapy.
Treatment:
Device: Cryoablation

Trial contacts and locations

1

Loading...

Central trial contact

Vanessa M Sanvido, PhD; Afonso P Nazário, Professor

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems