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NCT04738292 · ClinicalTrials.gov registry record · Phase 2
Onapristone and Fulvestrant for ER+ HER2- Metastatic Breast Cancer After Endocrine Therapy and CDK4/6 Inhibitors (The SMILE Study)
A Phase 2 study, sponsored by University of Wisconsin, Madison.
- Terminated
- Registry status
- Phase 2
- Development phase
- 11
- Enrollment target
NCT04738292 is a Phase 2 study that was terminated before completion, run by University of Wisconsin, Madison. The registered enrollment target is 11 participants.
The verdict
NCT04738292, a Phase 2 study, was terminated before completion, sponsored by University of Wisconsin, Madison.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 11 participants
- Enrollment target
Study Summary
A phase II single-arm trial of onapristone in combination with fulvestrant for women and men with ER-positive, PgR-positive or negative and HER2-negative locally advanced or metastatic breast cancer after progression on aromatase and CDK4/6 inhibitors. The study will enroll up to 39 participants.
Interventions
- DRUG Fulvestrant
- DRUG Onapristone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2021-10-05 |
| Est. Completion | 2023-05-15 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04738292
The ClinicalTrials.gov registry entry for NCT04738292 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Wisconsin, Madison, which has 1,039 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Fulvestrant is the first listed.
NCT04738292 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04738292 about?
NCT04738292 is a clinical study titled "Onapristone and Fulvestrant for ER+ HER2- Metastatic Breast Cancer After Endocrine Therapy and CDK4/6 Inhibitors (The SMILE Study)". A phase II single-arm trial of onapristone in combination with fulvestrant for women and men with ER-positive, PgR-positive or negative and HER2-negative locally advanced or metastatic breast cancer after progression on aromatase and CDK4/6 inhibitors. The study will enroll up to 39 participants.
What is the current status of trial NCT04738292?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2021-10-05. Estimated completion is 2023-05-15.
What interventions are being tested in trial NCT04738292?
The interventions under investigation include: Fulvestrant (DRUG), Onapristone (DRUG).
Who is sponsoring clinical trial NCT04738292?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
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