FreezIng bReaST Cancer in Brazil: a Before-after Study

NCT05398497 | Unknown DMC

• 1 other identifier: FIRST
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Breast Neoplasms

Keywords

cryoablation, cryotherapy, breast cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Negative predictive value of magnetic resonance imaging (MRI)

  14 days and 28 days

• Accuracy of conventional imaging methods (mammography and ultrasound)

  14 days and 28 days

• Measurement of the ice ball by ultrasound

  14 days and 28 days

Study Arms (1)

Early stage breast cancer up to 2.5 cm

EXPERIMENTAL

Patients treated with Cryocare SL followed by traditional surgery, radiotherapy and adjuvant systemic therapy.

Device: Cryoablation

Interventions

Cryoablation DEVICE

Cryoablation will be performed under ultrasound guidance.

Early stage breast cancer up to 2.5 cm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital do Coracao: lead

Study Sites (1)

Hcor

São Paulo, São Paulo, 04004-030, Brazil

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cryosurgery

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Alexandre B Cavalcanti, PhD

  Hospital do Coracao

  STUDY DIRECTOR

• Bruna MP Vianna

  Hospital do Coracao

  PRINCIPAL INVESTIGATOR

• Vanessa M Sanvido, PhD

  Hospital do Coracao

  PRINCIPAL INVESTIGATOR

• Afonso CP Nazário, Professor

  Hospital do Coracao

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vanessa M Sanvido, PhD

CONTACT

551138864688; dravanessasanvido@gmail.com

Afonso P Nazário, Professor

CONTACT

nazarioafonso@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2022
• First Posted: June 1, 2022
• Study Start: September 15, 2022
• Primary Completion: June 15, 2024
• Study Completion: July 15, 2024
• Last Updated: September 21, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

BR (1)