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NCT03025035 · ClinicalTrials.gov registry record · Phase 2
Pembrolizumab in Combination With Olaparib in Advanced BRCA-mutated or HDR-defect Breast Cancer
A Phase 2 study, sponsored by Yuan Yuan.
- Completed
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
NCT03025035: Completed Phase 2 study, sponsored by Yuan Yuan.
NCT03025035 is a Phase 2 study that has completed, run by Yuan Yuan. The registered enrollment target is 14 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03025035, a Phase 2 study, has completed, sponsored by Yuan Yuan.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
Study Summary
This trial will evaluate the use of immunotherapy and PARP inhibition in a population with incurable advanced breast cancer associated with a germline BRCA mutation or HDR-defect. The main objective is to examine overall response rate of pembrolizumab (immunotherapy) in combination with Olaparib (PARP inhibitor) in advanced BRCA-mutated or Homology-directed repair (HDR)-defect breast cancer.
Primary Outcome
Defined as complete or partial response or stable disease per RECIST 1.1 criteria with assessment every 9 weeks during the first year and while on the study drug, and every 12 weeks thereafter. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), a tumor that is nei
Interventions
- DRUG Pembrolizumab
- DRUG Olaparib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2017-09-10 |
| Est. Completion | 2025-11-21 |
| Phase | Phase 2 |
What the finished NCT03025035 record still lists
NCT03025035 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT03025035 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03025035 about?
NCT03025035 is a clinical study titled "Pembrolizumab in Combination With Olaparib in Advanced BRCA-mutated or HDR-defect Breast Cancer". This trial will evaluate the use of immunotherapy and PARP inhibition in a population with incurable advanced breast cancer associated with a germline BRCA mutation or HDR-defect. The main objective is to examine overall response rate of pembrolizumab (immunotherapy) in combination with Olaparib (PA...
What is the current status of trial NCT03025035?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2017-09-10. Estimated completion is 2025-11-21.
What interventions are being tested in trial NCT03025035?
The interventions under investigation include: Pembrolizumab (DRUG), Olaparib (DRUG).
Who is sponsoring clinical trial NCT03025035?
This trial is sponsored by Yuan Yuan, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03025035's enrollment target sits among peer trials
14 1941st of 2000 higher than 54 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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