Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
A Phase III Randomized Trial of Metformin vs Placebo in Early Stage Breast Cancer
NCT01101438 · View on ClinicalTrials.gov ↗
Study Summary
This study is looking at whether Metformin, an agent that is commonly used to treat diabetes, can decrease or affect the ability of breast cancer cells to grow and whether Metformin will work with other therapies to keep cancer from recurring. Health Canada has not approved the sale or use of Metformin to treat breast cancer, although they have approved its use in this clinical trial. Although Metformin is approved by the FDA for the treatment of diabetes, its use in breast cancer is considered investigational.
Conditions Studied
Interventions
- OTHER placebo
- DRUG metformin hydrochloride
Study Locations (20)
California
- Kaiser Permanente-Deer Valley Medical Center — Antioch
- Alta Bates Summit Medical Center-Herrick Campus — Berkeley
- Enloe Medical Center — Chico
- Glendale Memorial Hospital and Health Center — Glendale
- Kaiser Permanente, Hayward — Hayward
- Moores University of California San Diego Cancer Center — La Jolla
- Long Beach Memorial Medical Center-Todd Cancer Institute — Long Beach
- University of Southern California — Los Angeles
- University of California at Los Angeles (UCLA ) — Los Angeles
- Fremont - Rideout Cancer Center — Marysville
- Bay Area Tumor Institution CCOP — Oakland
- Kaiser Permanente-Oakland — Oakland
- University of California Medical Center At Irvine-Orange Campus — Orange
- Pomona Valley Hospital Medical Center — Pomona
Arizona
- Pinnacle Oncology Associates — Scottsdale
- Mayo Clinic in Arizona — Scottsdale
- Arizona Cancer Center at University Medical Center North — Tucson
- University of Arizona Health Sciences Center — Tucson
Alaska
- Providence Alaska Medical Center — Anchorage
- Fairbanks Memorial Hospital — Fairbanks
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,649 participants |
| Start Date | 2010-08-13 |
| Est. Completion | 2023-08-18 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01101438
The ClinicalTrials.gov registry entry for NCT01101438 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 3,649 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Canadian Cancer Trials Group, which has 102 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions — of which placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01101438 reports 20 study locations spanning 3 distinct geographic areas — top geographies include California, Arizona, Alaska. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01101438 about?
NCT01101438 is a clinical study titled "A Phase III Randomized Trial of Metformin vs Placebo in Early Stage Breast Cancer". This study is looking at whether Metformin, an agent that is commonly used to treat diabetes, can decrease or affect the ability of breast cancer cells to grow and whether Metformin will work with other therapies to keep cancer from recurring. Health Canada has not approved the sale or use of Metfor...
What is the current status of trial NCT01101438?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,649 participants. The study started on 2010-08-13. Estimated completion is 2023-08-18.
What conditions does trial NCT01101438 study?
This clinical trial studies the following conditions: Breast Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01101438?
The interventions under investigation include: placebo (OTHER), metformin hydrochloride (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01101438?
This trial is sponsored by Canadian Cancer Trials Group, which has 102 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01101438 being conducted?
This trial has 20 study locations across Alaska, Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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