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NCT02395627 · ClinicalTrials.gov registry record · Phase 2
Reversing Therapy Resistance With Epigenetic-Immune Modification
A Phase 2 study, sponsored by University of California, San Francisco.
- Terminated
- Registry status
- Phase 2
- Development phase
- 38
- Enrollment target
NCT02395627: Clinical Trial Phase 2 study, sponsored by University of California, San Francisco.
NCT02395627 is a Phase 2 study that was terminated before completion, run by University of California, San Francisco. The registered enrollment target is 38 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02395627, a Phase 2 study, was terminated before completion, sponsored by University of California, San Francisco.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 38 participants
- Enrollment target
Study Summary
The investigators propose a randomized two arm trial, using Simon's 2-stage design, in ER+ patients with therapy resistant breast cancer to test the optimal sequence and dosing of epigenetic immune priming in hormone therapy resistance breast cancer. A third arm (Arm C) will include ER-negative patients who will follow the concurrent priming, but exclude tamoxifen. The two arms all include vorinostat, tamoxifen, and pembrolizumab to evaluate * Sequential priming - begin pembrolizumab in Cycle 1 (Arm B and Arm C) and, * Concurrent priming with maximal dosing of both epigenetic and immune modulators- begin pembrolizumab on day 1 in Cycle 2 (Arm A)
Primary Outcome
Objective response rate (ORR) will be defined as the proportion of participants whose status is stable disease (SD) or better (complete response (CR), partial response (PR)) at 24 weeks' follow-up as measured by Response Evaluation Criteria in Solid Tumors (RECIST). The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started)
Interventions
- DRUG Pembrolizumab
- DRUG Tamoxifen
- DRUG Vorinostat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2015-05-04 |
| Est. Completion | 2019-06-08 |
| Phase | Phase 2 |
Why NCT02395627 stopped before completion
NCT02395627 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT02395627 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02395627 about?
NCT02395627 is a clinical study titled "Reversing Therapy Resistance With Epigenetic-Immune Modification". The investigators propose a randomized two arm trial, using Simon's 2-stage design, in ER+ patients with therapy resistant breast cancer to test the optimal sequence and dosing of epigenetic immune priming in hormone therapy resistance breast cancer. A third arm (Arm C) will include ER-negative pati...
What is the current status of trial NCT02395627?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2015-05-04. Estimated completion is 2019-06-08.
What interventions are being tested in trial NCT02395627?
The interventions under investigation include: Pembrolizumab (DRUG), Tamoxifen (DRUG), Vorinostat (DRUG).
Who is sponsoring clinical trial NCT02395627?
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 NCT02395627's enrollment target sits among peer trials
38 1467th of 2000 higher than 517 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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