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NCT01151215 · ClinicalTrials.gov registry record · Phase 2
Study of Anastrozole +/- AZD8931 in Postmenopausal Women With Endocrine Therapy Naive Breast Cancer
A Phase 2 study, sponsored by AstraZeneca.
- Terminated
- Registry status
- Phase 2
- Development phase
- 482
- Enrollment target
NCT01151215: Clinical Trial Phase 2 study, sponsored by AstraZeneca.
NCT01151215 is a Phase 2 study that was terminated before completion, run by AstraZeneca. The registered enrollment target is 482 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (262% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01151215, a Phase 2 study, was terminated before completion, sponsored by AstraZeneca.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 482 participants
- Enrollment target
Study Summary
The main purpose of this study is to compare progression free survival in patients treated with AZD8931 given in combination with anastrozole versus anastrozole alone. The secondary objective is to investigate the safety and tolerability of AZD8931 given in combination with anastrozole.
Primary Outcome
Time from the date of randomization until the date of objective disease progression (as per RECIST 1.1) or the date of death (by any cause in the absence of progression). Disease progression is defined using RECIST 1.1 as \>=20% increase in the sum of longest diameters of target lesions and an absolute increase of \>=5mm, taking as reference the smallest sum of longest diameters of target lesions since study start, or unequivocal progression in non-target lesions, or appearance of any new lesion
Interventions
- DRUG Placebo
- DRUG anastrozole
- DRUG AZD8931
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 482 participants |
| Start Date | 2010-06 |
| Est. Completion | 2013-01 |
| Phase | Phase 2 |
Why NCT01151215 stopped before completion
NCT01151215 is an interventional study that assigns participants to a tested intervention. The registered 482 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (262% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01151215 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01151215 about?
NCT01151215 is a clinical study titled "Study of Anastrozole +/- AZD8931 in Postmenopausal Women With Endocrine Therapy Naive Breast Cancer". The main purpose of this study is to compare progression free survival in patients treated with AZD8931 given in combination with anastrozole versus anastrozole alone. The secondary objective is to investigate the safety and tolerability of AZD8931 given in combination with anastrozole.
What is the current status of trial NCT01151215?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 482 participants. The study started on 2010-06. Estimated completion is 2013-01.
What interventions are being tested in trial NCT01151215?
The interventions under investigation include: Placebo (DRUG), anastrozole (DRUG), AZD8931 (DRUG).
Who is sponsoring clinical trial NCT01151215?
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 NCT01151215's enrollment target sits among peer trials
482 76th of 2000 higher than 1,925 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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