NCT06763328 · City of Hope Medical Center
Metformin for the Treatment of Insulin Resistance in Women With Stage I-III Breast Cancer Completing Chemotherapy
What this study is about
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.
View original scientific description
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.
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
Primary outcome measures
Hemoglobin A1c (Hgb A1c) normalization
Time frame: Up 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
Where
- Duarte, California
- La Jolla, California
- Riverside, California
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 12, 2026 · Source of record for eligibility and locations