Can a common diabetes drug protect breast cancer survivors from insulin resistance?
NCT ID NCT06763328
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase III trial tests whether metformin, a drug that lowers blood sugar, can prevent or reverse insulin resistance in women with stage I-III breast cancer who have completed chemotherapy. Insulin resistance is a risk factor for diabetes and heart disease, and chemotherapy may worsen it. The study will compare metformin plus standard diet and exercise education to standard care alone in 80 women over 12 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Metformin
- What this could lead to
- If it works, this could point toward a way to reduce the risk of diabetes and heart disease in breast cancer survivors after chemotherapy.
- What could go wrong
- This is a relatively small, early-phase trial (80 participants) and the impact of metformin in this specific group is unknown. It may not show a clear benefit over standard care alone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2024
- Expected to finish
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Jun 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Documented informed consent of the participant and/or legally authorized representative * Agreement to allow lab draw of approximately 26 mL of blood (less than 2 tablespoons) * To check blood counts, organ function and disease at baseline and 12 months * Review of clinical charts at pre-registration\* (refer to Study Calendar), baseline, 3 months, 6 months,12 months, and 24 months * Research labs at baseline, 6 months,12 months, and 24 months * Age: ≥ 18 years * Female sex assigned at birth * Ability to read and understand English or Spanish for questionnaires * Diagnosis of invasive breast cancer stages I-III * Completed adjuvant treatment for Stage 1-3 breast cancer within 5 years and are disease free. * Women who receive drugs for weight loss - e.g. semaglutide - prior to diagnosis are eligible for this protocol and can continue the drug during the intervention. Exclusion Criteria: * Currently taking metformin or any other oral antidiabetic medications. Weight loss medications are permitted - e.g. semaglutide * Taking tamoxifen or aromatase inhibitor * Contraindication to metformin prevention such as acute hypersensitivity or allergic reaction to metformin * Participants with acute or chronic renal insufficiency (a glomerular filtration rate \[GFR\] \< 60 mL/min/1.73m\^2) or those with acute renal insufficiency of any severity due to hepato-renal syndrome or in the peri-operative liver transplantation period * Bilirubin of \>2.5 mg/dL (normal range 0.1-1.2 mg/dL). * Previously diagnosed type 1 or type 2 diabetes * Patients pregnant or within 1 year of pregnancy and completion of lactation (to be determined at randomization). * Other active malignancy. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial * Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures * An employee who is under the direct/indirect supervision of the principal investigator (PI)/a co-investigator/the study manager and/or a direct study team member * Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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City of Hope Medical Center
RECRUITINGDuarte, California, 91010, United States
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UC San Diego Moores Cancer Center
NOT_YET_RECRUITINGLa Jolla, California, 92093, United States
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University of California-Riverside
NOT_YET_RECRUITINGRiverside, California, 92521, United States
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