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NCT03225547 · ClinicalTrials.gov registry record · Phase 2
Study of Pembrolizumab and Mifepristone in Patients With Advanced HER2-negative Breast Cancer
A Phase 2 study, sponsored by University of Chicago.
- Terminated
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
NCT03225547: Clinical Trial Phase 2 study, sponsored by University of Chicago.
NCT03225547 is a Phase 2 study that was terminated before completion, run by University of Chicago. The registered enrollment target is 24 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03225547, a Phase 2 study, was terminated before completion, sponsored by University of Chicago.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
Study Summary
This is a Phase II study of pembrolizumab plus mifepristone in advanced breast cancer patients. The study will include a safety lead in of ten patients. Patients who are deemed eligible and have signed informed consent will be treated with pembrolizumab at a fixed dose of 200 mg intravenously on day 1 of each 21 day cycle for each dose level. Mifepristone 300mg PO be administered daily starting the week prior to pembrolizumab. Once the safety of the combination is confirmed (study will be paused at least 6 weeks after first 10 patients are enrolled for safety evaluation), dose expansion cohorts will be performed in parallel for two cohorts: cohort 1 in triple-negative breast cancer and cohort 2 in hormone receptor positive breast cancer.
Primary Outcome
Determine the overall response rate (ORR) based on RECIST 1.1 of the combination of pembrolizumab and mifepristone in the different subtypes of breast cancer (hormone receptor positive and triple-negative)
Interventions
- DRUG Pembrolizumab
- DRUG Mifepristone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2018-02-12 |
| Est. Completion | 2025-09-30 |
| Phase | Phase 2 |
Why NCT03225547 stopped before completion
NCT03225547 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT03225547 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03225547 about?
NCT03225547 is a clinical study titled "Study of Pembrolizumab and Mifepristone in Patients With Advanced HER2-negative Breast Cancer". This is a Phase II study of pembrolizumab plus mifepristone in advanced breast cancer patients. The study will include a safety lead in of ten patients. Patients who are deemed eligible and have signed informed consent will be treated with pembrolizumab at a fixed dose of 200 mg intravenously on day...
What is the current status of trial NCT03225547?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2018-02-12. Estimated completion is 2025-09-30.
What interventions are being tested in trial NCT03225547?
The interventions under investigation include: Pembrolizumab (DRUG), Mifepristone (DRUG).
Who is sponsoring clinical trial NCT03225547?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03225547's enrollment target sits among peer trials
24 1756th of 2000 higher than 217 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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