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NCT01225172 · ClinicalTrials.gov registry record · Phase 2
Study of BMS-754807 Combined With Letrozole or BMS-754807 Alone in Patients With Hormone Receptor-Positive Breast Cancer and Resistance to Non-Steroidal Aromatase Inhibitors
A Phase 2 study, sponsored by Bristol-Myers Squibb.
- Terminated
- Registry status
- Phase 2
- Development phase
- 77
- Enrollment target
NCT01225172: Clinical Trial Phase 2 study, sponsored by Bristol-Myers Squibb.
NCT01225172 is a Phase 2 study that was terminated before completion, run by Bristol-Myers Squibb. The registered enrollment target is 77 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01225172, a Phase 2 study, was terminated before completion, sponsored by Bristol-Myers Squibb.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 77 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate oral doses of BMS-754807 in combination with letrozole or BMS-754807 alone are safe and efficacious in locally advanced or metastatic hormone receptor positive breast cancer subjects who have progressed with prior non-steroidal aromatase inhibitor treatment.
Primary Outcome
Progression free survival (PFS) rate at 24 weeks after treatment with BMS 754807/letrozole was to be calculated as the total number of subjects neither progressed nor died after 24 weeks of treatment divided by the total number of subjects (with measurable or non-measurable disease) randomized/assigned to combination treatment arm and treated. In participants with measurable disease Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) criteria was to be used to assess disease prog
Interventions
- DRUG letrozole
- DRUG BMS-754807
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2010-12-31 |
| Est. Completion | 2014-11-30 |
| Phase | Phase 2 |
Why NCT01225172 stopped before completion
NCT01225172 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 77 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 2 interventions - of which letrozole is the first listed.
NCT01225172 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01225172 about?
NCT01225172 is a clinical study titled "Study of BMS-754807 Combined With Letrozole or BMS-754807 Alone in Patients With Hormone Receptor-Positive Breast Cancer and Resistance to Non-Steroidal Aromatase Inhibitors". The purpose of this study is to evaluate oral doses of BMS-754807 in combination with letrozole or BMS-754807 alone are safe and efficacious in locally advanced or metastatic hormone receptor positive breast cancer subjects who have progressed with prior non-steroidal aromatase inhibitor treatment.
What is the current status of trial NCT01225172?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 77 participants. The study started on 2010-12-31. Estimated completion is 2014-11-30.
What interventions are being tested in trial NCT01225172?
The interventions under investigation include: letrozole (DRUG), BMS-754807 (DRUG).
Who is sponsoring clinical trial NCT01225172?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01225172's enrollment target sits among peer trials
77 891st of 2000 higher than 1,108 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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