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NCT03167619 · ClinicalTrials.gov registry record · Phase 2
Phase II Multicenter Study of Durvalumab and Olaparib in Platinum tReated Advanced Triple Negative Breast Cancer (DORA)
A Phase 2 study, sponsored by Duke University.
- Completed
- Registry status
- Phase 2
- Development phase
- 45
- Enrollment target
NCT03167619: Completed Phase 2 study, sponsored by Duke University.
NCT03167619 is a Phase 2 study that has completed, run by Duke University. The registered enrollment target is 45 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (66% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03167619, a Phase 2 study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 45 participants
- Enrollment target
Study Summary
This is a randomized, international, multicenter, Phase II study designed to explore the efficacy of olaparib or olaparib in combination with durvalumab in platinum-treated mTNBC. The primary objectives are to explore olaparib or olaparib in combination with durvalumab as maintenance therapy following clinical benefit with platinum-based therapy in subjects with mTNBC.
Primary Outcome
PFS, defined as the time from randomization to the first occurrence of disease progression or death from any cause on study for olaparib alone. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Death on study is defined as death from any cause within 30 days of the last dose of study treatment reg
Interventions
- DRUG Olaparib Oral Product
- DRUG Olaparib Oral Product in combination with Durvalumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2018-10-04 |
| Est. Completion | 2022-06-30 |
| Phase | Phase 2 |
What the finished NCT03167619 record still lists
NCT03167619 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (66% lower).
The record links to 0 conditions, and to 2 interventions - of which Olaparib Oral Product is the first listed.
NCT03167619 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03167619 about?
NCT03167619 is a clinical study titled "Phase II Multicenter Study of Durvalumab and Olaparib in Platinum tReated Advanced Triple Negative Breast Cancer (DORA)". This is a randomized, international, multicenter, Phase II study designed to explore the efficacy of olaparib or olaparib in combination with durvalumab in platinum-treated mTNBC. The primary objectives are to explore olaparib or olaparib in combination with durvalumab as maintenance therapy followi...
What is the current status of trial NCT03167619?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2018-10-04. Estimated completion is 2022-06-30.
What interventions are being tested in trial NCT03167619?
The interventions under investigation include: Olaparib Oral Product (DRUG), Olaparib Oral Product in combination with Durvalumab (DRUG).
Who is sponsoring clinical trial NCT03167619?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03167619's enrollment target sits among peer trials
45 1296th of 2000 higher than 679 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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