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Phase II Study of Metformin for Reduction of Obesity-Associated Breast Cancer Risk

NCT02028221 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 151

Last updated 2023-06-27

Study results available
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Summary

Overweight and obesity are well established risk factors for breast cancer that develop after menopause. The increased postmenopausal breast cancer risk in women who are overweight or obese is likely to be attributed to multiple metabolic disturbances. Metformin is a commonly used medication in diabetics to stabilize blood sugar. Association studies and laboratory studies have shown its potential to reduce the risk for development of cancer, including breast cancer. Recent pilot clinical studies in breast cancer patients suggest that metformin may only be effective in overweight or obese women with metabolic disturbances. We propose to conduct a clinical study of metformin in overweight or obese premenopausal women with metabolic disturbances. Study participants will be randomly assigned to receive metformin or placebo for 12 months. The study will evaluate whether metformin can result in favorable changes in risk features that have been associated with increased breast cancer risk. The risk features that will be examined in our study include breast density, certain proteins and hormones, products of body metabolism, and body weight and composition. The study should help determine the potential breast cancer preventive activity of metformin in a growing population at risk for multiple diseases.

Conditions

  • Breast Cancer Prevention

Interventions

DRUG

Metformin

metformin 850 mg 1 tablet taken by mouth daily X 4 weeks, then metformin 850 mg 1 tablet taken twice daily for the duration of he intervention period.

DRUG

Placebo

1 tablet daily by mouth X 4 weeks, then 1 tablet twice daily by mouth for the remaining duration of the trial (12 months)

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Arizona

    lead OTHER

Principal Investigators

  • Sherry Chow, PhD · University of Arizona

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
54 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-07
Primary Completion
2018-11-30
Completion
2022-06-14
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02028221 on ClinicalTrials.gov