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NCT02000622 · ClinicalTrials.gov registry record · Phase 3
Assessment of the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations.
A Phase 3 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 302
- Enrollment target
NCT02000622: Completed Phase 3 study, sponsored by AstraZeneca.
NCT02000622 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 302 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02000622, a Phase 3 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 302 participants
- Enrollment target
Study Summary
This open label, randomised, controlled, multi-centre phase III study will assess the efficacy and safety of single agent olaparib vs standard of care based on physician's choice of capecitabine, vinorelbine or eribulin in metastatic breast cancer patients with gBRCA 1/2 mutations.
Primary Outcome
Time from randomisation to the earliest of objective radiological progression or death by any cause in the absence of objective progression. Objective radiological progression is defined using Response Evaluation Criteria In Solid Tumours (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.
Interventions
- DRUG Olaparib
- DRUG Physician's choice chemotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 302 participants |
| Start Date | 2014-03-27 |
| Est. Completion | 2025-12-23 |
| Phase | Phase 3 |
What the finished NCT02000622 record still lists
NCT02000622 is an interventional study that assigns participants to a tested intervention. The registered 302 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower).
The record links to 0 conditions, and to 2 interventions - of which Olaparib is the first listed.
NCT02000622 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02000622 about?
NCT02000622 is a clinical study titled "Assessment of the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations.". This open label, randomised, controlled, multi-centre phase III study will assess the efficacy and safety of single agent olaparib vs standard of care based on physician's choice of capecitabine, vinorelbine or eribulin in metastatic breast cancer patients with gBRCA 1/2 mutations.
What is the current status of trial NCT02000622?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 302 participants. The study started on 2014-03-27. Estimated completion is 2025-12-23.
What interventions are being tested in trial NCT02000622?
The interventions under investigation include: Olaparib (DRUG), Physician's choice chemotherapy (DRUG).
Who is sponsoring clinical trial NCT02000622?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02000622's enrollment target sits among peer trials
302 1119th of 2000 higher than 880 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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