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NCT02694809 · ClinicalTrials.gov registry record · Phase 2
The PROMISE Study: Duavee in Women With DCIS
A Phase 2 study, sponsored by Northwestern University.
- Completed
- Registry status
- Phase 2
- Development phase
- 142
- Enrollment target
NCT02694809: Completed Phase 2 study, sponsored by Northwestern University.
NCT02694809 is a Phase 2 study that has completed, run by Northwestern University. The registered enrollment target is 142 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02694809, a Phase 2 study, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 142 participants
- Enrollment target
Study Summary
The main purpose of this study is to determine if taking the study drug, conjugated estrogens/bazedoxifene (Duavee®) causes any changes in the proliferation markers within the breast tissue of the study subjects. The study drug is approved by the US Food and Drug Administration in healthy postmenopausal women to treat certain symptoms of menopause such as hot flashes. Since it is not approved in women with DCIS, its use in this study is experimental. This study will also look at whether taking the study drug causes any significant or undesirable side effects in women with DCIS. The researchers hope that this study will help them determine if taking the study drug is safe in women taking DCIS and if it can possibly reduce the risk of developing breast cancer in women with DCIS.
Primary Outcome
Evaluating if CE/BZA reduces proliferation as measured by Ki-67 protein expression. Change in Ki-67 between baseline and end of the intervention will be measured.
Interventions
- OTHER Placebo
- OTHER Laboratory Biomarker Analysis
- PROCEDURE Quality-of-Life Assessment
- OTHER Pharmacological Study
- DRUG Conjugated Estrogens/Bazedoxifene
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 142 participants |
| Start Date | 2017-01 |
| Est. Completion | 2024-06-19 |
| Phase | Phase 2 |
What the finished NCT02694809 record still lists
NCT02694809 is an interventional study that assigns participants to a tested intervention. The registered 142 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT02694809 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02694809 about?
NCT02694809 is a clinical study titled "The PROMISE Study: Duavee in Women With DCIS". The main purpose of this study is to determine if taking the study drug, conjugated estrogens/bazedoxifene (Duavee®) causes any changes in the proliferation markers within the breast tissue of the study subjects. The study drug is approved by the US Food and Drug Administration in healthy postmenopa...
What is the current status of trial NCT02694809?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 142 participants. The study started on 2017-01. Estimated completion is 2024-06-19.
What interventions are being tested in trial NCT02694809?
The interventions under investigation include: Placebo (OTHER), Laboratory Biomarker Analysis (OTHER), Quality-of-Life Assessment (PROCEDURE), Pharmacological Study (OTHER), Conjugated Estrogens/Bazedoxifene (DRUG).
Who is sponsoring clinical trial NCT02694809?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02694809's enrollment target sits among peer trials
142 507th of 2000 higher than 1,491 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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