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RECRUITING
NCT06763328
PHASE3

Metformin for the Treatment of Insulin Resistance in Women With Stage I-III Breast Cancer Completing Chemotherapy

Sponsor: City of Hope Medical Center

View on ClinicalTrials.gov

Summary

This phase III trial evaluates how often women develop insulin resistance and type-2 diabetes and compares metformin with usual care to usual care alone in treating insulin resistance in women with stage I-III breast cancer after chemotherapy. Insulin resistance occurs when cells stop responding to insulin and is a risk factor for developing diabetes and heart disease. Higher levels of insulin have been shown to be associated with aggressive breast cancer. Metformin hydrochloride decreases the amount of glucose (a type of sugar) released into the bloodstream from the liver and increases the body's use of the glucose. Metformin as well as standard of care diet and exercise education is known to lower blood sugar. However, chemotherapy may accelerate metabolic disorders, such as high blood sugar, and the impact of metformin in these breast cancer survivors is not known. Giving metformin with usual care may be more effective than usual care alone in preventing or reversing insulin resistance in women with stage I-III breast cancer after chemotherapy.

Official title: Metformin (Dimethylbiguanide) and Insulin Resistance in Women Completing Neoadjuvant and/or Adjuvant Cytotoxic Treatment of Stage I-III Breast Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2024-12-16

Completion Date

2029-06-16

Last Updated

2026-01-22

Healthy Volunteers

No

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

OTHER

Educational Intervention

Receive standard of care healthy diet and exercise handouts

DRUG

Extended Release Metformin Hydrochloride

Given PO

OTHER

Questionnaire Administration

Ancillary studies

Locations (3)

City of Hope Medical Center

Duarte, California, United States

UC San Diego Moores Cancer Center

La Jolla, California, United States

University of California-Riverside

Riverside, California, United States