Metformin for the Treatment of Insulin Resistance in Women With Stage I-III Breast Cancer Completing Chemotherapy
NCT ID: NCT06763328
Last Updated: 2026-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
200 participants
INTERVENTIONAL
2024-12-16
2029-06-16
Brief Summary
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Detailed Description
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I. To determine if extended release metformin hydrochloride (metformin) can normalize glycosylated hemoglobin (HgbA1c) (\< 5.7%) for women breast cancer survivors with HgbA1c between 5.7-6.4%.
EXPLORATORY OBJECTIVES:
I. To investigate whether metformin treatment of insulin resistance (versus standard of care alone) alters epigenetic changes (chromatin acetylation, chromatin opening, and methylation) and the level of inflammatory cytokines. (Pilot) II. To investigate whether normalization of HgbA1c alters epigenetic changes (chromatin acetylation, chromatin opening, and methylation) and the level of inflammatory cytokines. (Pilot)
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive standard of care healthy diet and exercise handouts and extended release metformin orally (PO) once daily (QD) for 12 months in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection throughout the study.
ARM II: Patients receive standard of care healthy diet and exercise handouts on study. Additionally, patients undergo blood sample collection throughout the study.
After completion of study treatment, patients are followed up at 30 days and in 12 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Arm I (standard of care, metformin)
Patients receive standard of care healthy diet and exercise handouts and extended release metformin PO QD for 12 months in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection throughout the study.
Biospecimen Collection
Undergo blood sample collection
Educational Intervention
Receive standard of care healthy diet and exercise handouts
Extended Release Metformin Hydrochloride
Given PO
Questionnaire Administration
Ancillary studies
Arm II (standard of care)
Patients receive standard of care healthy diet and exercise handouts on study. Additionally, patients undergo blood sample collection throughout the study.
Biospecimen Collection
Undergo blood sample collection
Educational Intervention
Receive standard of care healthy diet and exercise handouts
Questionnaire Administration
Ancillary studies
Interventions
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Biospecimen Collection
Undergo blood sample collection
Educational Intervention
Receive standard of care healthy diet and exercise handouts
Extended Release Metformin Hydrochloride
Given PO
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Victoria L Seewaldt
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Locations
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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
Countries
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Facility Contacts
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Other Identifiers
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24363
Identifier Type: -
Identifier Source: org_study_id
NCI-2024-10402
Identifier Type: REGISTRY
Identifier Source: secondary_id
24363
Identifier Type: OTHER
Identifier Source: secondary_id
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