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Metformin Hydrochloride in Treating Patients With Early-Stage Breast Cancer

2014-08-27 03:14:39 | BioPortfolio

Summary

RATIONALE: Metformin hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This randomized phase III trial is studying how well metformin hydrochloride works compared with placebo in treating patients with early-stage breast cancer.

Description

OBJECTIVES:

Primary

- To compare invasive disease-free survival of patients with early-stage breast cancer treated with metformin hydrochloride vs placebo in addition to standard adjuvant therapy.

Secondary

- To compare overall survival of these patients.

- To compare distant disease-free survival of these patients.

- To compare breast cancer-free interval in these patients.

- To compare invasive disease-free survival of patients who are hormone receptor-negative (both estrogen receptor and progesterone receptor).

- To compare changes in body mass index in these patients.

- To compare adverse events in these patients.

- To compare other medical endpoints, including a new diagnosis of diabetes mellitus or cardiovascular hospitalization (including an emergency room visit or overnight stay) or death (stroke or myocardial infarction), in these patients.

- To compare health-related quality of life measured using the EORTC QLQ-C30 (supplemented by a trial-specific checklist), the Block Alive Screener, and physical activity items from the Nurses Health Study Questionnaire II on a subset of these patients.

- To compare embedded correlative science outcomes including plasma insulin and molecular markers of metformin hydrochloride action in these patients.

- To compare metabolic parameters including metabolic components of the insulin resistance syndrome as defined by the ATP III criteria in a subset of these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to hormone-receptor status (estrogen receptor- and/or progesterone receptor- positive vs both receptors negative), body mass index (≤ 30 vs > 30 kg/m²), HER2 status (positive vs negative), and prior chemotherapy (any vs none). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive oral metformin hydrochloride twice daily (once daily in weeks 1-4). Treatment continues for up to 5 years in the absence of disease progression or unacceptable toxicity.

- Arm II: Patients receive oral placebo twice daily (once daily in weeks 1-4). Treatment continues for up to 5 years in the absence of disease progression or unacceptable toxicity.

Blood and tumor samples are collected periodically for correlative studies.

Patients may complete quality-of-life, physical activity, and diet questionnaires at baseline and at 6, 12, 24, 36, 48, and 60 months.

After completion of study treatment, patients are followed annually.

Study Design

Allocation: Randomized, Control: Placebo Control, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Breast Cancer

Intervention

metformin hydrochloride, placebo

Status

Not yet recruiting

Source

NCIC Clinical Trials Group

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:39-0400

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