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

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.

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Key information

Conditions

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

Age range

55 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre Léon Bérard

Lyon, 69008, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cryoablation

Device

Other names: Cryotherapy

Primary outcomes

The rate of success of cryoablation procedure

Time frame: 45 days after cryoablation

percentage of viable cells in the piece of lumpectomy

Sponsors and collaborators

Lead sponsor

Centre Leon Berard

Other

Registry information

Acronym: CRYOSE01

Important dates

Study start: 2016
Primary completion: 2020
Study completion: 2020
First posted: Oct 15, 2015
Registry last updated: Oct 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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