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NCT03063619 · ClinicalTrials.gov registry record · Phase 2
Afimoxifene in Reducing the Risk of Breast Cancer in Women With Mammographically Dense Breast
A Phase 2 study of Mammographically Dense Breast, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 194
- Enrollment target
- 5
- Study locations
NCT03063619: Completed Phase 2 study of Mammographically Dense Breast, sponsored by M.D. Anderson Cancer Center.
NCT03063619 is a Phase 2 study of Mammographically Dense Breast that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 194 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (46% higher). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03063619, a Phase 2 study of Mammographically Dense Breast, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 194 participants
- Enrollment target
- 5
- Study locations
Study Summary
This randomized phase II trial studies how well afimoxifene works in reducing the risk of breast cancer in women with mammographically dense breast. Estrogen can cause the growth of breast cancer cells. Hormone therapy using afimoxifene may fight breast cancer by blocking the use of estrogen by the tumor cells.
Primary Outcome
To determine change of mammographic breast density using Cumulus software. Cumulus is a semi-automated computerized measure of dense area that uses reader-based thresholds to define the breast edge and regions of density on a digital or digitized mammogram. Each pixel within the breast area between the skin line and pectoral muscle is segmented into either fat or fibro glandular tissue; this defines the cut-off point.
Conditions Studied
Interventions
- OTHER Placebo
- OTHER Laboratory Biomarker Analysis
- OTHER Questionnaire Administration
- DRUG Afimoxifene
Study Locations (5)
Florida
- Moffitt Cancer Center - Tampa
Illinois
- Northwestern University - Chicago
Massachusetts
- Dana-Farber Cancer Institute - Boston
New York
- Columbia University/Herbert Irving Cancer Center - New York
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 194 participants |
| Start Date | 2018-01-30 |
| Est. Completion | 2021-10-26 |
| Phase | Phase 2 |
What the finished NCT03063619 record still lists
NCT03063619 is an interventional study that assigns participants to a tested intervention. The registered 194 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (46% higher).
The record links to 1 condition, with Mammographically Dense Breast appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT03063619 lists 5 locations in 5 states (Florida, Illinois, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT03063619 about?
NCT03063619 is a clinical study titled "Afimoxifene in Reducing the Risk of Breast Cancer in Women With Mammographically Dense Breast". This randomized phase II trial studies how well afimoxifene works in reducing the risk of breast cancer in women with mammographically dense breast. Estrogen can cause the growth of breast cancer cells. Hormone therapy using afimoxifene may fight breast cancer by blocking the use of estrogen by the ...
What is the current status of trial NCT03063619?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 194 participants. The study started on 2018-01-30. Estimated completion is 2021-10-26.
What conditions does trial NCT03063619 study?
This clinical trial studies the following conditions: Mammographically Dense Breast.
What interventions are being tested in trial NCT03063619?
The interventions under investigation include: Placebo (OTHER), Laboratory Biomarker Analysis (OTHER), Questionnaire Administration (OTHER), Afimoxifene (DRUG).
Who is sponsoring clinical trial NCT03063619?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03063619 being conducted?
This trial has 5 study locations across Florida, Illinois, Massachusetts, New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03063619's enrollment target sits among peer trials
194 352nd of 2000 higher than 1,649 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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