Clinical Trials /

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

NCT02576106

Description:

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.

Related Conditions:
  • Breast Invasive Ductal Carcinoma
Recruiting Status:

Completed

Phase:

N/A

URL:

https://clinicaltrials.gov/show/NCT02576106

Trial Eligibility

Document

Title

  • Brief Title: Evaluation of Percutaneous Treatment by Cryoablation of Unifocal Invasive Breast Carcinoma in Menopausal Women With Indication of Lumpectomy
  • Official Title: Evaluation of Percutaneous Treatment by Cryoablation of Unifocal Invasive Breast Carcinoma in Menopausal Women With Indication of Lumpectomy

Clinical Trial IDs

  • ORG STUDY ID: ET15-001
  • NCT ID: NCT02576106

Conditions

  • Carcinoma, Ductal, Breast
  • Menopausal

Purpose

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.

Trial Arms

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

    Eligibility 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
    Maximum Eligible Age:N/A
    Minimum Eligible Age:55 Years
    Eligible Gender:Female
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:The rate of success of cryoablation procedure
    Time Frame:45 days after cryoablation
    Safety Issue:
    Description:percentage of viable cells in the piece of lumpectomy

    Details

    Phase:N/A
    Primary Purpose:Interventional
    Overall Status:Completed
    Lead Sponsor:Centre Leon Berard

    Last Updated

    October 22, 2020