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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: Completed Phase 3 study of Breast Cancer, sponsored by Canadian Cancer Trials Group.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Invasive disease-free survival (IDFS) is defined as percentage of patients without documented development of ipsilateral and contralateral invasive breast tumour, local/regional invasive recurrence, distant recurrence, death from any causes. If a subject has not had invasive disease or died at the time of data cut-off for this final analysis, IDFS was censored on the date of last follow-up.
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 |
What the finished NCT01101438 record still lists
NCT01101438 is an interventional study that assigns participants to a tested intervention. Its 3,649 participants enrollment target places it among the larger protocols in the corpus, above the 2,800-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (30% higher).
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 names 20 study sites across 3 states, led by 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.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01101438's enrollment target sits among peer trials
3,649 41st of 1224 higher than 1,184 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer 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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