Back to resultsFreezIng bReaST Cancer in Brazil: a Before-after Study (FIRST)
Primary Purpose
Breast Cancer, Breast Neoplasms
Status
Not yet recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Cryoablation
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring cryoablation, cryotherapy, breast cancer
Eligibility Criteria
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
Sites / Locations
- Hcor
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Early stage breast cancer up to 2.5 cm
Arm Description
Patients treated with Cryocare SL followed by traditional surgery, radiotherapy and adjuvant systemic therapy.
Outcomes
Primary Outcome Measures
Tumor ablation
Successful tumor ablation will be defined as absence of residual viable invasive or in situ carcinoma in the surgical specimen.
Secondary Outcome Measures
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.
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.
Measurement of the ice ball by ultrasound
To compare the baseline tumor size, ultrasound measurement of the ice ball, and the pathological result.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05398497
Brief Title
FreezIng bReaST Cancer in Brazil: a Before-after Study
Acronym
FIRST
Official Title
Evaluation of Cryoablation in the Local Treatment of Early Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 15, 2022 (Anticipated)
Primary Completion Date
June 15, 2024 (Anticipated)
Study Completion Date
July 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital do Coracao
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
Core biopsy
Mammogram
Magnetic resonance imaging
Ultrasound
Tumor Cryoablation
Mammogram (post-cryoablation)
Magnetic resonance imaging (post-cryoablation)
Ultrasound (post-cryoablation)
Surgery
Evaluation of outcomes
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Breast Neoplasms
Keywords
cryoablation, cryotherapy, breast cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Early stage breast cancer up to 2.5 cm
Arm Type
Experimental
Arm Description
Patients treated with Cryocare SL followed by traditional surgery, radiotherapy and adjuvant systemic therapy.
Intervention Type
Device
Intervention Name(s)
Cryoablation
Intervention Description
Cryoablation will be performed under ultrasound guidance.
Primary Outcome Measure Information:
Title
Tumor ablation
Description
Successful tumor ablation will be defined as absence of residual viable invasive or in situ carcinoma in the surgical specimen.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Negative predictive value of magnetic resonance imaging (MRI)
Description
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.
Time Frame
14 days and 28 days
Title
Accuracy of conventional imaging methods (mammography and ultrasound)
Description
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.
Time Frame
14 days and 28 days
Title
Measurement of the ice ball by ultrasound
Description
To compare the baseline tumor size, ultrasound measurement of the ice ball, and the pathological result.
Time Frame
14 days and 28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vanessa M Sanvido, PhD
Phone
551138864688
Email
dravanessasanvido@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Afonso P Nazário, Professor
Email
nazarioafonso@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandre B Cavalcanti, PhD
Organizational Affiliation
Hospital do Coracao
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Bruna MP Vianna
Organizational Affiliation
Hospital do Coracao
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vanessa M Sanvido, PhD
Organizational Affiliation
Hospital do Coracao
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Afonso CP Nazário, Professor
Organizational Affiliation
Hospital do Coracao
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hcor
City
São Paulo
State/Province
SP
ZIP/Postal Code
04004-030
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanessa M Sanvido, Phd
Phone
551130536611
Email
dravanessasanvido@gmail.com
First Name & Middle Initial & Last Name & Degree
Vanessa M Sanvido, PhD
First Name & Middle Initial & Last Name & Degree
Afonso CP Nazário, Professor
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
There is a plan to share IPD in the article publication.
Learn more about this trial
FreezIng bReaST Cancer in Brazil: a Before-after Study
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