FreezIng bReaST Cancer in Brazil: a Before-after Study

Breast Cancer Clinical Trial

— FIRST  

Official title:

Evaluation of Cryoablation in the Local Treatment of Early Breast Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05398497
• Other study ID #: FIRST
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 15, 2022
• Est. completion date: July 15, 2024

Study information

• Verified date: May 2022
• Source: Hospital do Coracao
• Contact: Vanessa M Sanvido, PhD
• Phone: 551138864688
• Email: dravanessasanvido[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: July 15, 2024
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Device:
• Cryoablation
Cryoablation will be performed under ultrasound guidance.

Locations

Country	Name	City	State
Brazil	Hcor	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Hospital do Coracao

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor ablation	Successful tumor ablation will be defined as absence of residual viable invasive or in situ carcinoma in the surgical specimen.	1 month
Secondary	Negative predictive value of magnetic resonance imaging (MRI)	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.	14 days and 28 days
Secondary	Accuracy of conventional imaging methods (mammography and ultrasound)	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.	14 days and 28 days
Secondary	Measurement of the ice ball by ultrasound	To compare the baseline tumor size, ultrasound measurement of the ice ball, and the pathological result.	14 days and 28 days