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NCT number NCT01905046
Study type Interventional
Source Alliance for Clinical Trials in Oncology
Contact Victoria Seewaldt, MD
Phone (626) 471-7321
Status Recruiting
Phase Phase 3
Start date August 2013

Clinical Trial Summary

The purpose of this research study is to test whether metformin, a drug commonly used to treat diabetes, is able to get rid of atypia (early cell changes that are thought to be a marker of breast cancer risk) in women at increased risk for breast cancer. There will be testing for the presence of atypia in the breast after metformin is given to see if it can get rid of atypia. The study will compare the effects, good and/or bad, of metformin or placebo on atypia to find out which is better.

Note: The standard drug used for the "breast cancer prevention" is tamoxifen. If the patient is eligible to take tamoxifen, he/she must be offered tamoxifen prevention as part of clinical care. Metformin and tamoxifen are not similar and function differently. This study is not investigating the use of tamoxifen. Metformin is not approved for preventing breast cancer, but is currently being tested to determine if it can prevent breast cancer.


Clinical Trial Description

A total of 400 premenopausal women (200 per arm) will be pre-registered, among which 300 patients with atypia (Masood Score 14-17) on random periareolar fine needle aspiration (RPFNA) at baseline are expected to be randomized between Metformin and placebo control arm. It is expected that the accrual rate will be 5 to 10 patients per month and that accrual will be completed about 4 years after study activation. The randomization will be stratified for known BRCA mutation (BRCA1 or BRCA2 mutation vs. no mutation), prior excisional biopsy (atypical epithelial hyperplasia, atypical lobular hyperplasia, flat epithelial hyperplasia vs. DCIS vs. LCIS), and baseline fasting insulin > 2x ULN vs. ≤ 2x ULN.

The primary and secondary objectives are described below.

Primary Objective:

• Test for the presence or absence of cytological atypia in RPFNA bilateral aspirates after 12 and 24 months (24 month is optional for placebo-only group for patients who remain on placebo arm and will not receive metformin) for women receiving metformin versus placebo control. The presence of cytological atypia means any atypia in any RPFNA specimen.

Secondary Objectives:

- Use the Masood Cytology Index Score to test for the presence of cytological atypia or disappearance of cytological atypia in RPFNA bilateral aspirates after 12 months for both arms, and 24 months (24 month is optional for placebo-only group for patients who remain on placebo arm and will not receive metformin, and mandatory for crossover patients) for women receiving metformin 850 mg PO BID (metformin group).

- Compare Masood Cytology Score values at 0 and 12 months in the right and left breasts from the same individual in the metformin and placebo groups.

- Test the reproducibility of reverse phase protein microarray (RPPM) in duplicate RPPM determinations from individual RPFNA specimens.

- Correlate baseline RPPM values with presence of atypia (as measured by Masood Cytology Index Score) at month 12 and month 24 (month 24 optional for placebo-only group; for patients who remain on placebo arm and will not receive metformin) RPFNA.

- Determine the change in percent breast density from prior to the initiation of metformin or placebo treatment through therapy (ie, at 12 and 24 months), and following therapy (ie, 36 and 48 months).

Follow up visits will be performed at 36 and 48 months after the start of treatment.


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention


Related Conditions & MeSH terms


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