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

Hospital do Coracao

Status: Not yet enrolling

Conditions: Breast Cancer; Breast Neoplasms

Treatments: Device: Cryoablation

Study type: Interventional

Funder types: Other

Identifiers

NCT05398497

FIRST

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)

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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