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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 is a Phase 2 study that was terminated before completion, run by University of Chicago. The registered enrollment target is 24 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03225547
The ClinicalTrials.gov registry entry for NCT03225547 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Chicago, which has 796 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT03225547 reports 0 study locations.
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.
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