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NCT04542135 · ClinicalTrials.gov registry record · Phase 2
Sulindac and Breast Density in Women at Risk of Developing Breast Cancer
A Phase 2 study, sponsored by Alison Stopeck.
- Completed
- Registry status
- Phase 2
- Development phase
- 62
- Enrollment target
NCT04542135: Completed Phase 2 study, sponsored by Alison Stopeck.
NCT04542135 is a Phase 2 study that has completed, run by Alison Stopeck. The registered enrollment target is 62 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04542135, a Phase 2 study, has completed, sponsored by Alison Stopeck.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 62 participants
- Enrollment target
Study Summary
The primary objective of this study is to determine if sulindac at a dose of 150 mg twice a day for 12 months reduces breast density in postmenopausal women at elevated risk of breast cancer when compared to a placebo control.
Primary Outcome
The primary objective of this study is to determine if sulindac at a dose of 150 mg BID for 12 months reduces breast density in postmenopausal women at elevated risk of breast cancer when compared to a placebo control. The dependent variable is the relative change in percent breast density. Percent breast density is the estimated percentage of breast volume that appears dense versus fatty on the MRI, and relative change is calculated as the difference between the follow-up and baseline values di
Interventions
- DRUG Placebo
- DRUG Sulindac Pill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2020-11-20 |
| Est. Completion | 2025-05-19 |
| Phase | Phase 2 |
What the finished NCT04542135 record still lists
NCT04542135 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04542135 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04542135 about?
NCT04542135 is a clinical study titled "Sulindac and Breast Density in Women at Risk of Developing Breast Cancer". The primary objective of this study is to determine if sulindac at a dose of 150 mg twice a day for 12 months reduces breast density in postmenopausal women at elevated risk of breast cancer when compared to a placebo control.
What is the current status of trial NCT04542135?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 62 participants. The study started on 2020-11-20. Estimated completion is 2025-05-19.
What interventions are being tested in trial NCT04542135?
The interventions under investigation include: Placebo (DRUG), Sulindac Pill (DRUG).
Who is sponsoring clinical trial NCT04542135?
This trial is sponsored by Alison Stopeck, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04542135's enrollment target sits among peer trials
62 1016th of 2000 higher than 975 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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