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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: Clinical Trial Phase 2 study, sponsored by University of Wisconsin, Madison.
NCT04738292 is a Phase 2 study that was terminated before completion, run by University of Wisconsin, Madison. The registered enrollment target is 11 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Best overall response of complete response (CR) or partial response (PR), as per RECIST 1.1. Point and 95% interval estimate of ORR will be evaluated accounting for possibility of early futility stopping.
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 |
Why NCT04738292 stopped before completion
NCT04738292 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Fulvestrant is the first listed.
NCT04738292 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04738292's enrollment target sits among peer trials
11 1967th of 2000 higher than 33 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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