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NCT03544125 · ClinicalTrials.gov registry record · Phase 1
Olaparib and Durvalumab in Treating Participants With Metastatic Triple Negative Breast Cancer
A Phase 1 study, sponsored by OHSU Knight Cancer Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT03544125: Completed Phase 1 study, sponsored by OHSU Knight Cancer Institute.
NCT03544125 is a Phase 1 study that has completed, run by OHSU Knight Cancer Institute. The registered enrollment target is 3 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03544125, a Phase 1 study, has completed, sponsored by OHSU Knight Cancer Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
This pilot phase I trial studies whether it is feasible to conduct a detailed molecular profile of triple negative breast cancer as part of a treatment strategy that asks whether or not we can lower the chance of breast cancer growing or spreading, by treating with a combination of PARP inhibitor how well (olaparib) and immune therapy (durvalumab). Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving olaparib and durvalumab may work better in treating participants with metastatic triple negative breast cancer.
Primary Outcome
Using the feasibility analysis set, the proportion of the completed CLIA analytics within 4 weeks (i.e., from day 1, cycle 1 up to day 1 cycle 2 of on-study treatment regimen will be estimated relative to all screened participants who undergo a first biopsy with a 95% confidence interval.
Interventions
- BIOLOGICAL Durvalumab
- DRUG Olaparib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2018-05-03 |
| Est. Completion | 2020-11-18 |
| Phase | Phase 1 |
What the finished NCT03544125 record still lists
NCT03544125 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Durvalumab is the first listed.
NCT03544125 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03544125 about?
NCT03544125 is a clinical study titled "Olaparib and Durvalumab in Treating Participants With Metastatic Triple Negative Breast Cancer". This pilot phase I trial studies whether it is feasible to conduct a detailed molecular profile of triple negative breast cancer as part of a treatment strategy that asks whether or not we can lower the chance of breast cancer growing or spreading, by treating with a combination of PARP inhibitor ho...
What is the current status of trial NCT03544125?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2018-05-03. Estimated completion is 2020-11-18.
What interventions are being tested in trial NCT03544125?
The interventions under investigation include: Durvalumab (BIOLOGICAL), Olaparib (DRUG).
Who is sponsoring clinical trial NCT03544125?
This trial is sponsored by OHSU Knight Cancer Institute, which has 211 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03544125's enrollment target sits among peer trials
3 1999th of 2000 higher than 1 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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