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NCT02000882 · ClinicalTrials.gov registry record · Phase 2
STAR Cape+BKM120 MBC With Brain Met
A Phase 2 study, sponsored by US Oncology Research.
- Completed
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT02000882: Completed Phase 2 study, sponsored by US Oncology Research.
NCT02000882 is a Phase 2 study that has completed, run by US Oncology Research. The registered enrollment target is 10 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02000882, a Phase 2 study, has completed, sponsored by US Oncology Research.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study Summary
This is a study to determine the safety and effectiveness of BKM120 plus capecitabine in breast cancer patients with brain metastases. Both capecitabine and BMK120 have previously shown activity in patients with breast cancer. Like capecitabine, BMK120 is also effective in crossing the blood brain barrier making it a preferred candidate for its evaluation in patients with metastatic breast cancer (MBC).
Primary Outcome
CBR in the patients following WBRT or SRS or both will be the primary endpoint and is calculated as the total number of responders (CR or PR, assessed by RECIST 1.1) plus stable disease greater than or equal to 24 weeks (CR + PR + SD ≥ 24 weeks) divided by the total number of evaluable patients. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a
Interventions
- DRUG Trastuzumab
- DRUG capecitabine
- DRUG BKM120
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2014-05-29 |
| Est. Completion | 2019-03-29 |
| Phase | Phase 2 |
What the finished NCT02000882 record still lists
NCT02000882 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 3 interventions - of which Trastuzumab is the first listed.
NCT02000882 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02000882 about?
NCT02000882 is a clinical study titled "STAR Cape+BKM120 MBC With Brain Met". This is a study to determine the safety and effectiveness of BKM120 plus capecitabine in breast cancer patients with brain metastases. Both capecitabine and BMK120 have previously shown activity in patients with breast cancer. Like capecitabine, BMK120 is also effective in crossing the blood brain ...
What is the current status of trial NCT02000882?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2014-05-29. Estimated completion is 2019-03-29.
What interventions are being tested in trial NCT02000882?
The interventions under investigation include: Trastuzumab (DRUG), capecitabine (DRUG), BKM120 (DRUG).
Who is sponsoring clinical trial NCT02000882?
This trial is sponsored by US Oncology Research, which has 27 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02000882's enrollment target sits among peer trials
10 1968th of 2000 higher than 12 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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