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Metformin for Insulin Resistance in Breast Cancer Survivors

This study is looking at whether the medication extended release metformin hydrochloride can help women with stage I-III breast cancer who have finished chemotherapy and developed insulin resistance. Insulin resistance means your body's cells don't respond well to insulin, which can lead to diabetes and heart disease. Higher insulin levels have also been linked to more aggressive breast cancer. Researchers want to see if metformin, along with healthy diet and exercise information, can bring your blood sugar levels (measured by Hemoglobin A1c or Hgb A1c) back to normal. You may be eligible if you are a woman aged 18 or older with stage I-III breast cancer who has completed chemotherapy and has an Hgb A1c between 5.7-6.4%. The study is currently unclear about its recruitment status.

Study design
This is an interventional study where participants are randomly assigned to one of two groups: one receiving metformin and standard care, and the other receiving standard care only. The study plans to enroll 80 women.
What's involved
You would provide informed consent and allow blood samples to be collected at the start and after 12 months. Your medical charts would also be reviewed at several points over 12 months.
Compensation
Not stated in the trial record.
Follow-up
After completing the 12-month study treatment, participants will have follow-up appointments at 30 days and again at 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06763328

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

Recruiting
PHASE3Ages 18+InterventionalSupportive care
City of Hope Medical Center
~80 participants
Updated 2026-06-12 on ClinicalTrials.gov
What's tested:Biospecimen CollectionEducational InterventionExtended Release Metformin HydrochlorideQuestionnaire Administration

At a glance

Recruiting sites
1 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Hemoglobin A1c (Hgb A1c) normalization
Measured over Up to 12 months

Conditions

Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
Invasive Breast Carcinoma

Explore related trials

Breast Carcinoma

Where it's being run

3 sites across 1 states
California3

Study leadership

  • Victoria L Seewaldt · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center

Who to contact

Victoria L. Seewaldt
[email protected]
626-218-6321
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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

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)

What this trial measures

  • Hemoglobin A1c (Hgb A1c) normalizationUp to 12 months

    Will be defined as Hgb A1c \< 5.7%. Will be compared across groups (metformin + standard of care/usual medical care versus standard of care/usual medical care alone) using chi-square statistics. Data will be summarized using counts and percentages.