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Change in Mammographic Density With Metformin Use: A Companion Study to NCIC Study MA.32
Overall Recruitment Status: Enrollment complete
 
Official Title
Change in Mammographic Density With Metformin Use: A Companion Study to NCIC Study MA.32
 
Region Sponsors
California - Northern
Cancer and Leukemia Group B
 
Acronym NCT No.
NCT01666171
 
Study Type Phase
Clinical Trial
Phase II
 
Purpose
PURPOSE: This trial studies changes in breast density in patients with early-stage breast cancer treated with metformin hydrochloride or placebo on CAN-NCIC-MA.32.
 
Detailed Description
 
 
 
Inclusion Criteria
  • Patients must either be concurrently enrolling or previously enrolled to Canada (CAN) National Cancer Institute of Canada (NCIC) study MA.32 (CAN-NCIC-MA.32) (MA.32)
  • eligible patients may be either pre- or post-menopausal
  • Patients must have hormone receptor-negative breast cancer
  • Patients must have breast density = 25% (correlating with the Breast Imaging-Reporting and Data [BIRAD]-2 category of "scattered fibroglandular densities" or greater)
  • Baseline digital mammograms taken within 12 months prior to registration to MA.32, with at least a craniocaudal (CC) view used for enrollment to MA.32 must be available for submission
  • if the patient has previously enrolled to MA.32 and one year has elapsed from baseline mammograms, one-year mammograms must also be available for submission
  • Contralateral unaffected breast in place (with no prior cancer or radiation, no implants, and no plan for breast surgery on contralateral breast over the course of the study)
  • women with a prior biopsy on the unaffected breast are eligible
 
Exclusion Criteria
  • N/A
 
Keywords and/or Specific Medical Conditions
  • Obstetrics and Gynecology
  • Oncology (Adult)
 
KP Clinical Facility
  • All Kaiser Permanente Northern California Medical Centers
 
Clinical Area
  • Obstetrics and Gynecology
  • Oncology (Adult)


Principal Investigator:
Tatjana Kolevska
Contact Information:
- Desiree S Goldstein
-CTPCollaborate@kp.org
-Central Valley-Manteca


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