Carcinoma, Ductal, Breast, Menopausal
Conditions
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.
Interventions
DEVICECryoablation
Sponsors
Centre Leon Berard
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
55 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The rate of success of cryoablation procedure | 45 days after cryoablation | percentage of viable cells in the piece of lumpectomy |
Countries
France
Outcome results
None listed