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NCT00917735 · ClinicalTrials.gov registry record · Phase 2
Green Tea and Reduction of Breast Cancer Risk
A Phase 2 study, sponsored by University of Minnesota.
- Completed
- Registry status
- Phase 2
- Development phase
- 1,075
- Enrollment target
NCT00917735: Completed Phase 2 study, sponsored by University of Minnesota.
NCT00917735 is a Phase 2 study that has completed, run by University of Minnesota. The registered enrollment target is 1,075 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (708% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00917735, a Phase 2 study, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 1,075 participants
- Enrollment target
Study Summary
RATIONALE: Green tea extract contains ingredients (catechins) that may lower the risk of breast cancer. PURPOSE: This phase II trial is studying how well green tea extract works in preventing breast cancer compared to a placebo in postmenopausal women with high breast density. The investigators have hypothesized that green tea consumption reduces breast cancer risk, and this effect is seen primarily in women who have the low-activity COMT genotype. The investigators will test this by evaluating the effects of green tea extract on breast cancer biomarkers including mammographic density, plasma insulin-like growth factor 1 (IGF-1), IGF binding protein 3 (IGFBP-3), estrone, estradiol, androstenedione, sex hormone binding globulin (SHBG), urinary estrogen metabolites and plasma F2-isoprostanes.
Primary Outcome
Percent mammographic density was measured on digital images using a computer-assisted and quantitative method.
Interventions
- OTHER Placebo
- DRUG Green tea extract supplement
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,075 participants |
| Start Date | 2009-07 |
| Est. Completion | 2014-06 |
| Phase | Phase 2 |
What the finished NCT00917735 record still lists
NCT00917735 is an interventional study that assigns participants to a tested intervention. Its 1,075 participants enrollment target places it among the larger protocols in the corpus, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (708% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00917735 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00917735 about?
NCT00917735 is a clinical study titled "Green Tea and Reduction of Breast Cancer Risk". RATIONALE: Green tea extract contains ingredients (catechins) that may lower the risk of breast cancer. PURPOSE: This phase II trial is studying how well green tea extract works in preventing breast cancer compared to a placebo in postmenopausal women with high breast density. The investigators ha...
What is the current status of trial NCT00917735?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,075 participants. The study started on 2009-07. Estimated completion is 2014-06.
What interventions are being tested in trial NCT00917735?
The interventions under investigation include: Placebo (OTHER), Green tea extract supplement (DRUG).
Who is sponsoring clinical trial NCT00917735?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00917735's enrollment target sits among peer trials
1,075 23rd of 2000 higher than 1,978 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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