Metformin for the Treatment of Insulin Resistance in Women With Stage I-III Breast Cancer Completing Chemotherapy
Recruiting
Phase 3
Interventional Study
Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
Invasive Breast Carcinoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Supportive Care
- Participants needed
- 80 (estimated)
- Sponsor
- City of Hope Medical Center · Other
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About This Trial
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 hav…
Trial Locations
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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 2 tablespoons)
* To check blood counts, organ function and disease at baseline and 12 months
* Review of clinic…
Contacts
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