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NCT02561832 · ClinicalTrials.gov registry record · Phase 1
A Phase I, Open-Label, 2 Part Multicentre Study to Assess the Safety and Efficacy of Olaparib in Combination With Carboplatin in Patients With Advanced HER-2 Negative Breast Cancer
A Phase 1 study, sponsored by AstraZeneca.
- Terminated
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT02561832: Clinical Trial Phase 1 study, sponsored by AstraZeneca.
NCT02561832 is a Phase 1 study that was terminated before completion, run by AstraZeneca. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02561832, a Phase 1 study, was terminated before completion, sponsored by AstraZeneca.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
This is an open-label study to assess the safety, tolerability and efficacy of olaparib in combination with carboplatin. There are two parts in this study: Part A, a dose escalation in patients with advanced Human Epidermal Growth Factor 2 (HER-2) negative breast cancer and Part B, a dose expansion in the neoadjuvant treatment of HER-2 negative breast cancer patients with germline Breast Cancer Susceptibility Gene (BRCA)1/2 mutations.
Primary Outcome
Treatment-emergent AEs (TEAEs) defined as events occurring on or after cycle 1, day 1 up to and including 30 days after last dose (approximately 114 days).
Interventions
- DRUG Cyclophosphamide
- DRUG Carboplatin
- DRUG Olaparib
- DRUG Anthracycline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2015-11-06 |
| Est. Completion | 2017-02-01 |
| Phase | Phase 1 |
Why NCT02561832 stopped before completion
NCT02561832 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT02561832 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02561832 about?
NCT02561832 is a clinical study titled "A Phase I, Open-Label, 2 Part Multicentre Study to Assess the Safety and Efficacy of Olaparib in Combination With Carboplatin in Patients With Advanced HER-2 Negative Breast Cancer". This is an open-label study to assess the safety, tolerability and efficacy of olaparib in combination with carboplatin. There are two parts in this study: Part A, a dose escalation in patients with advanced Human Epidermal Growth Factor 2 (HER-2) negative breast cancer and Part B, a dose expansion ...
What is the current status of trial NCT02561832?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2015-11-06. Estimated completion is 2017-02-01.
What interventions are being tested in trial NCT02561832?
The interventions under investigation include: Cyclophosphamide (DRUG), Carboplatin (DRUG), Olaparib (DRUG), Anthracycline (DRUG).
Who is sponsoring clinical trial NCT02561832?
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 NCT02561832's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 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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