Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06763328 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusRecruiting
PhasePhase 3
Started2024-12-16
View on ClinicalTrials.gov ↗

Amendment history

2026-06-10
Study Status, Oversight, Study Design, Eligibility v3
Enrollment reduced: 200 → 80 participants
Eligibility criteria-49 characters
[...] o allow lab draw of approximately 26 mL of blood (less than 32 tablespoons) To check blood counts, organ function and disease at baseline and 12 months ClinicalReview labsof clinical charts at pre-registration* (refer to Study Calendar), baseline, 3 months, 6 months,12 months, and 24 months Resea [...] derstand English or Spanish for questionnaires Diagnosis of estrogen receptor (ER)-negative /HER2-wild type or -amplified invasive mammarybreast carcinomacancer stages I-III ReceiveCompleted systemicadjuvant treatment for breast cancer treatment Completed treatment for stageStage 1-3 breast cancer with [...] [...]
2026-01-21
Study Status v2
Re-verified, no change to tracked fields
2025-06-18
Study Status, Eligibility v1
Eligibility criteriarevised
[...] ment Completed treatment for stage 1-3 breast cancer within 3090 days to 35 years and are disease free Women who receive drugs for weig [...]
2025-01-02
Original filing
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.
Trial Details
NCT Number NCT06763328
Lead Sponsor City of Hope Medical Center
Collaborators: National Cancer Institute (NCI)
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
Enrollment 80 participants
Start Date 2024-12-16
Primary Completion 2029-06-16 (estimated)
Study Completion 2029-06-16 (estimated)
Updated on ClinicalTrials.gov 2026-06-12