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

NCT02576106 | Completed

• 1 other identifier: ET15-001
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma, Ductal, Breast; Menopausal

Outcome Measures

Primary Outcomes (1)

• The rate of success of cryoablation procedure

  percentage of viable cells in the piece of lumpectomy

  45 days after cryoablation

Study Arms (1)

Cryoablation

EXPERIMENTAL

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

Device: Cryoablation

Interventions

Cryoablation DEVICE

Also known as: Cryotherapy

Cryoablation

Eligibility Criteria

• Age: 55 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Invasive lobular carcinoma
• Tumor with retro-nipple location
• Extended microcalcifications (\> 15 mm) with mammography
• Xylocaine allergy
• Patient deprived of freedom

Sponsors & Collaborators

• Centre Leon Berard: lead

Study Sites (1)

Centre Léon Bérard

Lyon, 69008, France

Location

MeSH Terms

Conditions

Carcinoma, Ductal, Breast

Interventions

Cryosurgery; Cryotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Ductal; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Ductal, Lobular, and Medullary; Breast Neoplasms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative; Therapeutics

Study Officials

• Frank Pilleul, MD-PhD

  Centre Leon Berard

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2015
• First Posted: October 15, 2015
• Study Start: February 1, 2016
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: October 22, 2020

Record last verified: 2018-08

Locations

FR (1)