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

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT06763328
Phase
PHASE3
Status
Recruiting
Apply to this trial

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Educational Intervention — OTHER
    Receive standard of care healthy diet and exercise handouts
  • Extended Release Metformin Hydrochloride — DRUG
    Given PO
  • Questionnaire Administration — OTHER
    Ancillary studies

Study Details

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. Metformin hydrochloride decreases the amount of glucose (a type of sugar) released into the bloodstream from the liver and increases the body's use of the glucose. Metformin as well as standard of care diet and exercise education is known to lower blood sugar. However, chemotherapy may accelerate metabolic disorders, such as high blood sugar, and the impact of metformin in these breast cancer survivors is not known. Giving metformin with usual care may be more effective than usual care alone in preventing or reversing insulin resistance in women with stage I-III breast cancer after chemotherapy.

Key Dates

Start date
Dec 16, 2024
Status verified
Jan 2026
Primary completion
Jun 16, 2029
Completion
Jun 16, 2029

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: 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.
  • Active Comparator: 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.

Primary Outcome Measure

Hemoglobin A1c (Hgb A1c) normalization [ Time Frame: Up to 12 months ]

Locations (3)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010
Victoria L. Seewaldt
[email protected]
626-218-6321
Victoria L. Seewaldt (PRINCIPAL_INVESTIGATOR)
UC San Diego Moores Cancer CenterLa JollaCalifornia92093
Shankar Subramaniam
[email protected]
858-822-0986
Shankar Subramaniam (PRINCIPAL_INVESTIGATOR)
University of California-RiversideRiversideCalifornia92521
Kendrick A. Davis
[email protected]
951-827-2031
Kendrick A. Davis (PRINCIPAL_INVESTIGATOR)

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