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NCT06763328 · ClinicalTrials.gov registry record · Phase 3
Metformin for the Treatment of Insulin Resistance in Women With Stage I-III Breast Cancer Completing Chemotherapy
A Phase 3 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, sponsored by City of Hope Medical Center.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 200
- Enrollment target
- 3
- Study locations
NCT06763328: Recruiting Phase 3 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, sponsored by City of Hope Medical Center.
NCT06763328 is a Phase 3 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8 that is actively recruiting participants, run by City of Hope Medical Center. The registered enrollment target is 200 participants, below the 302-participant average among 84 other Anatomic Stage III Breast Cancer AJCC v8 trials with a reported enrollment target (34% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06763328, a Phase 3 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, is actively recruiting participants, sponsored by City of Hope Medical Center.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 200 participants
- Enrollment target
- 3
- Study locations
Study Summary
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.
Primary Outcome
Will be defined as Hgb A1c \< 5.7%. Will be compared across groups (metformin + standard of care/usual medical care versus standard of care/usual medical care alone) using chi-square statistics. Data will be summarized using counts and percentages.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- OTHER Questionnaire Administration
- OTHER Educational Intervention
- DRUG Extended Release Metformin Hydrochloride
Study Locations (3)
California
- City of Hope Medical Center - Duarte
- UC San Diego Moores Cancer Center - La Jolla
- University of California-Riverside - Riverside
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2024-12-16 |
| Est. Completion | 2029-06-16 |
| Phase | Phase 3 |
What NCT06763328 shows while recruiting
NCT06763328 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 302-participant average among 84 other Anatomic Stage III Breast Cancer AJCC v8 trials with a reported enrollment target (34% lower).
The record links to 4 conditions, with Anatomic Stage III Breast Cancer AJCC v8 appearing as the primary indexed condition, and to 4 interventions - of which Biospecimen Collection is the first listed.
NCT06763328 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06763328 about?
NCT06763328 is a clinical study titled "Metformin for the Treatment of Insulin Resistance in Women With Stage I-III Breast Cancer Completing Chemotherapy". 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 ...
What is the current status of trial NCT06763328?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 200 participants. The study started on 2024-12-16. Estimated completion is 2029-06-16.
What conditions does trial NCT06763328 study?
This clinical trial studies the following conditions: Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Invasive Breast Carcinoma.
What interventions are being tested in trial NCT06763328?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Questionnaire Administration (OTHER), Educational Intervention (OTHER), Extended Release Metformin Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT06763328?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06763328 being conducted?
This trial has 3 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06763328's enrollment target sits among peer trials
200 24th of 84 higher than 60 of 84 other Anatomic Stage III Breast Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anatomic Stage III Breast Cancer AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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