MAST Study Protocol
N/A
18 Years
N/A
18 Years
N/A
Not Enrolling
Female
Breast Cancer
Female
Breast Cancer
Trial Information
MAST Study Protocol
Use of the device will take place during a partial mastectomy procedure (lumpectomy).The
patient will be randomized to enter the device or control arm.
Inclusion Criteria
Inclusion criteria
1. Women diagnosed with carcinoma of the breast
2. Undergoing lumpectomy (local wide excision) procedure.
3. Over 18 years of age
4. Signed ICF
Exclusion criteria
1. Neoadjuvant systemic therapy
2. Previous radiation in the operated breast
3. Prior surgical procedure in the same quadrant
4. Implants in the operated breast
5. Pregnancy
6. Participating in any other investigational study for either drug or device which can
influence collection of valid data under this study.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Principal Investigator
Dan Hershko, Dr.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Rambam MC
Authority:
Israel: Israeli Health Ministry Pharmaceutical Administration
Study ID:
CP-02-001
NCT ID:
NCT00380952
Start Date:
November 2006
Completion Date:
April 2008
Related Keywords:
- Breast Cancer
- IDC
- DCIS
- ILC
- Breast Neoplasms
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