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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 : Recruiting
First Posted : October 15, 2015
Last Update Posted : August 23, 2018
Sponsor:
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine


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
Criteria

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


Contacts
Contact: Séverine METZGER severine.metzger@lyon.unicancer.fr

Locations
France
Centre Léon Bérard Recruiting
Lyon, France, 69008
Contact: Frank PILLEUL, MD-PhD       frank.pilleul@lyon.unicancer.fr   
Sponsors and Collaborators
Centre Leon Berard
Investigators
Principal Investigator: Frank Pilleul, MD-PhD Centre Leon Berard

Responsible Party: Centre Leon Berard
ClinicalTrials.gov Identifier: NCT02576106     History of Changes
Other Study ID Numbers: ET15-001
First Posted: October 15, 2015    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: August 2018

Additional relevant MeSH terms:
Carcinoma
Breast Neoplasms
Carcinoma, Ductal
Carcinoma, Ductal, Breast
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary