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

Carcinoma, Ductal, Breast Clinical Trial

— CRYOSE01  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02576106
• Other study ID #: ET15-001
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: January 2020

Study information

• Verified date: August 2018
• Source: Centre Leon Berard
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Carcinoma
• Carcinoma, Ductal
• Carcinoma, Ductal, Breast
• Menopausal

Intervention

Device:
• Cryoablation

Locations

Country	Name	City	State
France	Centre Léon Bérard	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Leon Berard

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of success of cryoablation procedure	percentage of viable cells in the piece of lumpectomy	45 days after cryoablation