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NCT04190056 · ClinicalTrials.gov registry record · Phase 2
Pembrolizumab and Tamoxifen With or Without Vorinostat for the Treatment of Estrogen Receptor Positive Breast Cancer
A Phase 2 study, sponsored by University of California, San Francisco.
- Terminated
- Registry status
- Phase 2
- Development phase
- 1
- Enrollment target
NCT04190056: Clinical Trial Phase 2 study, sponsored by University of California, San Francisco.
NCT04190056 is a Phase 2 study that was terminated before completion, run by University of California, San Francisco. The registered enrollment target is 1 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04190056, a Phase 2 study, was terminated before completion, sponsored by University of California, San Francisco.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 1 participants
- Enrollment target
Study Summary
This phase II trial studies how well pembrolizumab and tamoxifen with or without vorinostat work for the treatment of estrogen receptor positive breast cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Estrogen can cause the growth of breast cancer cells. Hormone therapy with tamoxifen may may fight breast cancer by blocking the use of estrogen by the tumor cells. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This trial is being done to find a drug combination to better control estrogen receptor positive breast cancer and reduce the number of pills taken.
Primary Outcome
ORR is defined as the proportion of participants randomized to that arm whose status is stable disease (SD) or better (complete response (CR), partial response (PR)). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: CR=Disappearance of all target lesions; PR = \>=30% decrease in the sum of the longest diameter of target lesions, and SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease,.
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Tamoxifen
- DRUG Vorinostat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2021-03-11 |
| Est. Completion | 2023-06-15 |
| Phase | Phase 2 |
Why NCT04190056 stopped before completion
NCT04190056 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT04190056 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04190056 about?
NCT04190056 is a clinical study titled "Pembrolizumab and Tamoxifen With or Without Vorinostat for the Treatment of Estrogen Receptor Positive Breast Cancer". This phase II trial studies how well pembrolizumab and tamoxifen with or without vorinostat work for the treatment of estrogen receptor positive breast cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with...
What is the current status of trial NCT04190056?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 1 participants. The study started on 2021-03-11. Estimated completion is 2023-06-15.
What interventions are being tested in trial NCT04190056?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Tamoxifen (DRUG), Vorinostat (DRUG).
Who is sponsoring clinical trial NCT04190056?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04190056's enrollment target sits among peer trials
1 2001st of 2000 the lowest 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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