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NCT01101438 · ClinicalTrials.gov registry record · Phase 3
A Phase III Randomized Trial of Metformin vs Placebo in Early Stage Breast Cancer
A Phase 3 study of Breast Cancer, sponsored by Canadian Cancer Trials Group.
- Completed
- Registry status
- Phase 3
- Development phase
- 3,649
- Enrollment target
- 20
- Study locations
NCT01101438 is a Phase 3 study of Breast Cancer that has completed, run by Canadian Cancer Trials Group. The registered enrollment target is 3,649 participants, above the 2,800-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (30% higher). The trial reports 20 study locations across 3 states.
The verdict
NCT01101438, a Phase 3 study of Breast Cancer, has completed, sponsored by Canadian Cancer Trials Group.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 3,649 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 3,649 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 2,800-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (30% higher). The listed sponsor is Canadian Cancer Trials Group, which has 16 total studies on file at ClinicalTrials.gov.
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.
NCT01101438 reports 20 study locations spanning 3 distinct geographic areas - top geographies include California, Arizona, Alaska.
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.
What interventions are being tested in trial NCT01101438?
The interventions under investigation include: placebo (OTHER), metformin hydrochloride (DRUG).
Who is sponsoring clinical trial NCT01101438?
This trial is sponsored by Canadian Cancer Trials Group, which has 16 total clinical trials registered on ClinicalTrials.gov.
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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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.