Evaluation of Percutaneous Treatment by Cryoablation of Unifocal Invasive Breast Carcinoma in Menopausal Women With Indication of Lumpectomy

Centre Leon Berard22 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Carcinoma, Ductal, Breast Menopausal

Interventions

Eligibility

Sex: FEMALEMin age: 55 Years

Medical Language ↔ Plain English

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

percentage of viable cells in the piece of lumpectomy

Time frame: 45 days after cryoablation