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

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ClinicalTrials.gov Identifier: NCT02576106
Recruitment Status : Completed
First Posted : October 15, 2015
Last Update Posted : October 22, 2020
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Carcinoma, Ductal, Breast Menopausal Device: Cryoablation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Percutaneous Treatment by Cryoablation of Unifocal Invasive Breast Carcinoma in Menopausal Women With Indication of Lumpectomy
Actual Study Start Date : February 2016
Actual Primary Completion Date : January 2020
Actual Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Cryoablation
Cryoablation of the tumor followed by a lumpectomy as practiced in standard care
Device: Cryoablation
Other Name: Cryotherapy

Primary Outcome Measures :
  1. The rate of success of cryoablation procedure [ Time Frame: 45 days after cryoablation ]
    percentage of viable cells in the piece of lumpectomy

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02576106

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Centre Léon Bérard
Lyon, France, 69008
Sponsors and Collaborators
Centre Leon Berard
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Principal Investigator: Frank Pilleul, MD-PhD Centre Leon Berard
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Responsible Party: Centre Leon Berard
ClinicalTrials.gov Identifier: NCT02576106    
Other Study ID Numbers: ET15-001
First Posted: October 15, 2015    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: August 2018
Additional relevant MeSH terms:
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Breast Neoplasms
Carcinoma, Ductal
Carcinoma, Ductal, Breast
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplasms, Ductal, Lobular, and Medullary