Studying Changes in Breast Density in Patients With Early-Stage Breast Cancer Treated With Metformin Hydrochloride or Placebo on CAN-NCIC-MA.32

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2013 by National Cancer Institute (NCI)
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01666171
First received: August 14, 2012
Last updated: July 9, 2013
Last verified: January 2013
  Purpose

RATIONALE: Learning about the effect of metformin hydrochloride in breast density of women with early-stage breast cancer may help plan treatment.

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.


Condition Intervention
Breast Cancer
Drug: metformin hydrochloride
Other: clinical observation
Other: diagnostic laboratory biomarker analysis
Other: imaging biomarker analysis
Other: medical chart review
Procedure: digital mammography

Study Type: Observational
Official Title: Change in Mammographic Density With Metformin Use: A Companion Study to NCIC Study MA.32

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Change in percent mammographic breast density in contralateral (unaffected) breast from baseline to 1 year using two-sample t-test or Wilcoxon rank-sum test [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in percent mammographic breast density in contralateral (unaffected) breast from baseline to 2 years using two-sample t-test [ Designated as safety issue: No ]
  • Correlation between baseline mammographic density and baseline plasma fasting insulin, glucose levels, and HOMA using a scatter plot, correlation-coefficient estimation, and linear-regression method [ Designated as safety issue: No ]
  • Correlation of changes in dense area in response to metformin therapy from pre-treatment to on treatment (at year 1 and year 2) with plasma fasting insulin, glucose levels, and HOMA using simple linear-regression method [ Designated as safety issue: No ]
  • Correlation between mammographic density and the incidence of second primary breast cancer using correlation coefficient and scatter plot [ Designated as safety issue: No ]

Estimated Enrollment: 458
Study Start Date: August 2012
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • To evaluate the change in percent mammographic density in contralateral (unaffected breast) from prior to the initiation of metformin hydrochloride (metformin) or placebo treatment through one year of therapy in patients with hormone receptor-negative breast cancer (i.e., not on endocrine therapy).

Secondary

  • To evaluate the change in percent breast density in contralateral (unaffected breast) from prior to the initiation of metformin or placebo treatment through two years of therapy in patients with hormone receptor-negative breast cancer (i.e., not on endocrine therapy).
  • To evaluate whether baseline mammographic density correlates with baseline of fasting plasma insulin, glucose levels, and Homeostasis Model Assessment (HOMA) (collected on the treatment protocol CAN-NCIC-MA.32) (MA.32).
  • To evaluate whether changes in dense area in response to metformin therapy from pre-treatment through two years of therapy correlate with changes in fasting plasma insulin, glucose levels, and HOMA (collected on the treatment protocol MA.32) over the same time period.
  • To explore whether change in mammographic density for women on metformin is associated with risk of second primary breast cancer.

OUTLINE: Patients' mammograms taken at baseline and at approximately 1 and 2 years of metformin or placebo treatment are retrieved and analyzed for breast-density change. Pre-menopausal patients' menstrual cycle information is also collected at baseline and every 6 months for 2 years.

  Eligibility

Ages Eligible for Study:   18 Years to 74 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Women receiving endocrine therapy (e.g., tamoxifen, aromatase inhibitors) are not eligible
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01666171

Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Principal Investigator: Marie E. Wood, MD University of Vermont
  More Information

Additional Information:
No publications provided

Responsible Party: Richard L. Schilsky, Cancer and Leukemia Group B
ClinicalTrials.gov Identifier: NCT01666171     History of Changes
Other Study ID Numbers: CALGB-A211201, CDR0000738328
Study First Received: August 14, 2012
Last Updated: July 9, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
estrogen receptor-negative breast cancer
progesterone receptor-negative breast cancer
stage IB breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIC breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014