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

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

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2020

Interventions

  • Device: Cryoablation

Arms, Groups and Cohorts

  • Experimental: Cryoablation
    • Cryoablation of the tumor followed by a lumpectomy as practiced in standard care

Clinical Trial Outcome Measures

Primary Measures

  • The rate of success of cryoablation procedure
    • Time Frame: 45 days after cryoablation
    • percentage of viable cells in the piece of lumpectomy

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 55 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centre Leon Berard
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Frank Pilleul, MD-PhD, Principal Investigator, Centre Leon Berard

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