Evaluation of Percutaneous Treatment by Cryoablation of Unifocal Invasive Breast Carcinoma in Menopausal Women With Indication of Lumpectomy (CRYOSE01)

Léon Bérard Center

Status: Completed

Conditions: Carcinoma, Ductal, Breast; Menopausal

Treatments: Device: Cryoablation

Study type: Interventional

Funder types: Other

Identifiers

NCT02576106

ET15-001

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: Female

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

Cryoablation

Experimental group

Description:

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

Treatment:

Device: Cryoablation