NCT02576106
Completed
Not Applicable
Evaluation of Percutaneous Treatment by Cryoablation of Unifocal Invasive Breast Carcinoma in Menopausal Women With Indication of Lumpectomy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Carcinoma, Ductal, Breast
- Sponsor
- Centre Leon Berard
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- The rate of success of cryoablation procedure
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
The rate of success of cryoablation procedure
Time Frame: 45 days after cryoablation
percentage of viable cells in the piece of lumpectomy
Study Sites (1)
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