RecruitingPhase 3NCT06763328

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

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


Sponsor

City of Hope Medical Center

Enrollment

200 participants

Start Date

Dec 16, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether metformin — a common and inexpensive diabetes drug — can reduce insulin resistance (a metabolic problem that can fuel cancer growth) in women who have completed chemotherapy for early-stage breast cancer. **You may be eligible if...** - You are a woman (female sex assigned at birth) aged 18 or older - You were diagnosed with estrogen receptor-negative (ER-) and/or HER2-positive or HER2-amplified invasive breast cancer, stage I–III - You have completed treatment for breast cancer within the past 90 days to 5 years and show signs of insulin resistance - You can read and understand English or Spanish - You are willing to have blood drawn at multiple timepoints **You may NOT be eligible if...** - You have not yet finished your breast cancer treatment - You do not have insulin resistance (as determined by lab testing) - Your cancer type does not match the study criteria (e.g., ER-positive/HER2-negative) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo blood sample collection

OTHEREducational Intervention

Receive standard of care healthy diet and exercise handouts

DRUGExtended Release Metformin Hydrochloride

Given PO

OTHERQuestionnaire 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

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NCT06763328


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