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New treatment option for Anatomic Stage I Breast Cancer AJCC v8
Official title Metformin for the Treatment of Insulin Resistance in Women With Stage I-III Breast Cancer Completing Chemotherapy
ClinicalTrials.gov ID: NCT06763328
What this study is testing
What is Extended Release Metformin Hydrochloride?
Extended Release Metformin Hydrochloride is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for anatomic stage i breast cancer ajcc v8.
Also referred to as ER Metformin Hydrochloride, Extended-release Metformin Hydrochloride.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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 clinical charts at pre-registration\ (refer to Study Calendar), baseline, 3 months, 6 months,12 months, and 24 months
- Research labs at baseline, 6 months,12 months, and 24 months
You likely can't join if
- 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] \< 60 mL/min/1.73m\^2) or those with acute renal...
- Bilirubin of \>2.5 mg/dL (normal range 0.1-1.2 mg/dL).
- Previously diagnosed type 1 or type 2 diabetes
See the full eligibility 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 clinical charts at pre-registration\ (refer to Study Calendar), 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 invasive breast cancer stages I-III
- Completed adjuvant treatment for Stage 1-3 breast cancer within 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.
- 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] \< 60 mL/min/1.73m\^2) or those with acute renal insufficiency of any severity due to hepato-renal syndrome or in the...
- Bilirubin of \>2.5 mg/dL (normal range 0.1-1.2 mg/dL).
- Previously diagnosed type 1 or type 2 diabetes
- Patients pregnant or within 1 year of pregnancy and completion of lactation (to be determined at randomization).
- 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 how well it works assessment of the investigational...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- La Jolla, California, United States
- Riverside, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; La Jolla, California, United States; Riverside, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.