FreezIng bReaST Cancer in Brazil: a Before-after Study

Not Applicable

• Conditions: Breast Cancer; Breast Neoplasms
• Interventions: Device: Cryoablation

• Registration Number: NCT05398497
• Lead Sponsor: Hospital do Coracao

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

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. 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

Study Timeline

• Status Verified: 2022-05
• Study First Submitted: 2022-05-26
• Study First Submitted QC: 2022-05-26
• Study First Posted: 2022-06-01
• Study Start: 2022-09-15
• Last Update Submitted: 2022-09-20
• Last Update Posted: 2022-09-21
• Primary Completion: 2024-06-15
• Study Completion: 2024-07-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Early stage breast cancer up to 2.5 cm	Cryoablation	Patients treated with Cryocare SL followed by traditional surgery, radiotherapy and adjuvant systemic therapy.

Primary Outcome Measures

Name	Time	Method
Tumor ablation	1 month	Successful tumor ablation will be defined as absence of residual viable invasive or in situ carcinoma in the surgical specimen.

Secondary Outcome Measures

Name	Time	Method
Negative predictive value of magnetic resonance imaging (MRI)	14 days and 28 days	Magnetic resonance imaging will be conducted between 14 to 28 days after cryoablation. Negative predictive value of MRI will be calculated according to the pathological report after the traditional surgery. Negative predictive value = number of the patients who is pathologically negative divided by the number of patients who is MRI negative.
Accuracy of conventional imaging methods (mammography and ultrasound)	14 days and 28 days	Mammography and ultrasound will be conducted between 14 to 28 days after cryoablation. Accuracy of conventional imaging methods will be calculated according to the pathological report after the traditional surgery.
Measurement of the ice ball by ultrasound	14 days and 28 days	To compare the baseline tumor size, ultrasound measurement of the ice ball, and the pathological result.

Trial Locations

Locations (1)

Hcor; 🇧🇷 São Paulo, SP, Brazil