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

Not Applicable

Completed

• Conditions: Carcinoma, Ductal, Breast; Menopausal

• Registration Number: NCT02576106
• Lead Sponsor: Centre Leon Berard

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-12
• Study First Submitted QC: 2015-10-13
• Study First Posted: 2015-10-15
• Study Start: 2016-02
• Status Verified: 2018-08
• Primary Completion: 2020-01
• Study Completion: 2020-01
• Last Update Submitted: 2020-10-20
• Last Update Posted: 2020-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The rate of success of cryoablation procedure	45 days after cryoablation	percentage of viable cells in the piece of lumpectomy

Trial Locations

Locations (1)

Centre Léon Bérard; 🇫🇷 Lyon, France