Back to resultsEvaluation of Percutaneous Treatment by Cryoablation of Unifocal Invasive Breast Carcinoma in Menopausal Women With Indication of Lumpectomy (CRYOSE01)
Primary Purpose
Carcinoma, Ductal, Breast, Menopausal
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cryoablation
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Ductal, Breast
Eligibility Criteria
Inclusion Criteria:
- Non inflammatory unilateral and unifocal breast cancer with indication of lumpectomy
- Menopausal women with age > 55 years
- Tumor size <= 15 mm by ultrasonography
- Histological confirmation (by biopsy) of invasive ductal carcinoma with SBR (Scarff-Bloom-Richardson) grade (modified by Ellis & Elston) 1 or 2; hormone receptors positive (Estrogen Receptor and/or Progesterone Receptor) and negative Human epidermal growth factor receptor (HER2)
- Good lesion boundary with ultrasonography and MRI
- Minimal distance of 5 mm between the skin and the tumor
- Performance Status 0-1
- Ability to understand and willingness to sign a written informed consent document
- Covered by a medical insurance
- Signed informed consent
Exclusion Criteria:
- Invasive lobular carcinoma
- Tumor with retro-nipple location
- Extended microcalcifications (> 15 mm) with mammography
- Xylocaine allergy
- Patient deprived of freedom
Sites / Locations
- Centre Léon Bérard
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cryoablation
Arm Description
Cryoablation of the tumor followed by a lumpectomy as practiced in standard care
Outcomes
Primary Outcome Measures
The rate of success of cryoablation procedure
percentage of viable cells in the piece of lumpectomy
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02576106
Brief Title
Evaluation of Percutaneous Treatment by Cryoablation of Unifocal Invasive Breast Carcinoma in Menopausal Women With Indication of Lumpectomy
Acronym
CRYOSE01
Official Title
Evaluation of Percutaneous Treatment by Cryoablation of Unifocal Invasive Breast Carcinoma in Menopausal Women With Indication of Lumpectomy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
January 2020 (Actual)
Study Completion Date
January 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Leon Berard
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary objective of this monocentric and feasibility study is to review the efficacy of cryotherapy in the treatment of unifocal mammary carcinomas in post-menopausal patients, with lumpectomy indication.
The efficacy is defined by the rate of success of cryotherapy procedures. For each one of those evaluated process, an success will be defined on the tumor sample of lumpectomy by the absence of viable tumour cells.
On the basis of our expertise, it seems interesting to propose this experimental procedure to patients as described above.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Ductal, Breast, Menopausal
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cryoablation
Arm Type
Experimental
Arm Description
Cryoablation of the tumor followed by a lumpectomy as practiced in standard care
Intervention Type
Device
Intervention Name(s)
Cryoablation
Other Intervention Name(s)
Cryotherapy
Primary Outcome Measure Information:
Title
The rate of success of cryoablation procedure
Description
percentage of viable cells in the piece of lumpectomy
Time Frame
45 days after cryoablation
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Non inflammatory unilateral and unifocal breast cancer with indication of lumpectomy
Menopausal women with age > 55 years
Tumor size <= 15 mm by ultrasonography
Histological confirmation (by biopsy) of invasive ductal carcinoma with SBR (Scarff-Bloom-Richardson) grade (modified by Ellis & Elston) 1 or 2; hormone receptors positive (Estrogen Receptor and/or Progesterone Receptor) and negative Human epidermal growth factor receptor (HER2)
Good lesion boundary with ultrasonography and MRI
Minimal distance of 5 mm between the skin and the tumor
Performance Status 0-1
Ability to understand and willingness to sign a written informed consent document
Covered by a medical insurance
Signed informed consent
Exclusion Criteria:
Invasive lobular carcinoma
Tumor with retro-nipple location
Extended microcalcifications (> 15 mm) with mammography
Xylocaine allergy
Patient deprived of freedom
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Pilleul, MD-PhD
Organizational Affiliation
Centre Leon Berard
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Léon Bérard
City
Lyon
ZIP/Postal Code
69008
Country
France
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Percutaneous Treatment by Cryoablation of Unifocal Invasive Breast Carcinoma in Menopausal Women With Indication of Lumpectomy
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