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NCT04821141 · ClinicalTrials.gov registry record · Phase 2
Phase IIB Trial of Bazedoxifene Plus Conjugated Estrogens
A Phase 2 study of Breast Cancer and Risk Reduction, sponsored by University of Kansas Medical Center.
- Active
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 6
- Study locations
NCT04821141 is a Phase 2 study of Breast Cancer and Risk Reduction that is active but no longer recruiting, run by University of Kansas Medical Center. The registered enrollment target is 120 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (96% lower). The trial reports 6 study locations across 5 states.
The verdict
NCT04821141, a Phase 2 study of Breast Cancer and Risk Reduction, is active but no longer recruiting, sponsored by University of Kansas Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
- 6
- Study locations
Study Summary
Women at risk for development of breast cancer and experiencing vasomotor menopausal symptoms (hot flashes) will be randomized to bazedoxifene (BZA) plus conjugated estrogens (CE) for 6 months versus a wait list control. Two risk factors for development of breast cancer will be studied pre-study and after 6 months: fibroglandular volume (FGV) on mammogram as assessed by Volpara software and proliferation by Ki-67 immunocytochemistry in benign breast tissue acquired by random periareolar fine needle aspiration (RPFNA). Change in biomarkers will be compared between groups.
Conditions Studied
Interventions
- DRUG Bazedoxifene and Conjugated Estrogens
Study Locations (6)
California
- City of Hope Medical Center - Duarte
- University of California San Francisco - San Francisco
Illinois
- Northwestern Medical Center - Chicago
Kansas
- University of Kansas Medical Center - Kansas City
Massachusetts
- Dana Farber Cancer Institute - Boston
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2021-12-14 |
| Est. Completion | 2027-07-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04821141
The ClinicalTrials.gov registry entry for NCT04821141 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (96% lower). The listed sponsor is University of Kansas Medical Center, which has 408 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which Bazedoxifene and Conjugated Estrogens is the first listed.
NCT04821141 reports 6 study locations spanning 5 distinct geographic areas - top geographies include California, Illinois, Kansas.
Frequently Asked Questions
What is clinical trial NCT04821141 about?
NCT04821141 is a clinical study titled "Phase IIB Trial of Bazedoxifene Plus Conjugated Estrogens". Women at risk for development of breast cancer and experiencing vasomotor menopausal symptoms (hot flashes) will be randomized to bazedoxifene (BZA) plus conjugated estrogens (CE) for 6 months versus a wait list control. Two risk factors for development of breast cancer will be studied pre-study and...
What is the current status of trial NCT04821141?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2021-12-14. Estimated completion is 2027-07-31.
What conditions does trial NCT04821141 study?
This clinical trial studies the following conditions: Breast Cancer, Risk Reduction.
What interventions are being tested in trial NCT04821141?
The interventions under investigation include: Bazedoxifene and Conjugated Estrogens (DRUG).
Who is sponsoring clinical trial NCT04821141?
This trial is sponsored by University of Kansas Medical Center, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04821141 being conducted?
This trial has 6 study locations across California, Illinois, Kansas, Massachusetts, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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