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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

August 14, 2012
July 9, 2013
August 2012
April 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01666171 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
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Studying Changes in Breast Density in Patients With Early-Stage Breast Cancer Treated With Metformin Hydrochloride or Placebo on CAN-NCIC-MA.32
Change in Mammographic Density With Metformin Use: A Companion Study to NCIC Study MA.32

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.

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.

Observational
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Breast Cancer
  • Drug: metformin hydrochloride
  • Other: clinical observation
  • Other: diagnostic laboratory biomarker analysis
  • Other: imaging biomarker analysis
  • Other: medical chart review
  • Procedure: digital mammography
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
458
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April 2013   (final data collection date for primary outcome measure)

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
Female
18 Years to 74 Years
No
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NCT01666171
CALGB-A211201, CDR0000738328
Not Provided
Richard L. Schilsky, Cancer and Leukemia Group B
Cancer and Leukemia Group B
National Cancer Institute (NCI)
Principal Investigator: Marie E. Wood, MD University of Vermont
National Cancer Institute (NCI)
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP