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

Launched by CITY OF HOPE MEDICAL CENTER · Jan 2, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether a medication called metformin can help women with early-stage breast cancer who have recently finished chemotherapy. The main focus is on how metformin might prevent or reduce insulin resistance, a condition where the body doesn’t respond well to insulin. Insulin resistance can increase the risk of developing diabetes and heart disease, which are concerns for breast cancer survivors. The trial will compare the effects of metformin alongside standard care, which includes diet and exercise guidance, to standard care alone to see which approach is more effective.

To participate in this trial, women must be at least 18 years old, have been diagnosed with specific types of early-stage breast cancer, and have completed their cancer treatment within the last 30 days to 3 years. They should also be free of disease and able to understand English or Spanish. Participants will need to allow blood tests at various points during the study to monitor their health. This trial is currently recruiting participants, so if you or someone you know fits the criteria, it could be a valuable opportunity to contribute to important research in cancer care.

Gender

FEMALE

Eligibility criteria

• 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 3 tablespoons)
• • To check blood counts, organ function and disease at baseline and 12 months
• • Clinical labs at 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 estrogen receptor (ER)-negative /HER2-wild type or -amplified invasive mammary carcinoma stages I-III
• • Receive systemic treatment for breast cancer treatment
• • Completed treatment for stage 1-3 breast cancer within 90 days to 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 \[GFR\] \< 30 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
• • Previously diagnosed type 1 or type 2 diabetes
• • Patients pregnant or within 1 year of pregnancy and completion of lactation (pregnancy tests are standard of care \[SOC\] for initiation of chemotherapy)
• • 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)