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NCT02088684 · ClinicalTrials.gov registry record · Phase 1
Study of LEE011 With Fulvestrant and BYL719 or BKM120 in Advanced Breast Cancer
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 70
- Enrollment target
NCT02088684: Completed Phase 1 study, sponsored by Novartis Pharmaceuticals.
NCT02088684 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 70 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02088684, a Phase 1 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 70 participants
- Enrollment target
Study Summary
The purpose of this trial is to explore the clinical utility of the three investigational agents in HR+, HER2- breast cancer. LEE011 (CDK4/6 inhibitor), BKM120 (PI3K-pan class I-inhibitor) and BYL719 (PI3K-alpha specific class I inhibitor) in combination with fulvestrant. This is a multi-center, open-label Phase Ib/II study. The Phase Ib portion of the study is a dose escalation to estimate the MTD and/or RP2D for three regimens: LEE011 with fulvestrant; LEE011 and BKM120 with fulvestrant; LEE011and BYL719 with fulvestrant. The Phase II portion of the study was planned to be a randomized study to assess the anti-tumor activity as well as safety and tolerability of LEE011 with fulvestrant to LEE011 and BKM120 with fulvestrant, and LEE011 and BYL719 with fulvestrant in patients with ER+/HER2- locally advanced or metastatic breast cancer. Approximately 216 adult women with ER+/HER2- locally advanced or metastatic breast cancer were planned to be enrolled.
Primary Outcome
Dose limiting toxicities
Interventions
- DRUG fulvestrant
- DRUG LEE011
- DRUG BYL719
- DRUG BKM120
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2014-05-19 |
| Est. Completion | 2018-04-17 |
| Phase | Phase 1 |
What the finished NCT02088684 record still lists
NCT02088684 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% higher).
The record links to 0 conditions, and to 4 interventions - of which fulvestrant is the first listed.
NCT02088684 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02088684 about?
NCT02088684 is a clinical study titled "Study of LEE011 With Fulvestrant and BYL719 or BKM120 in Advanced Breast Cancer". The purpose of this trial is to explore the clinical utility of the three investigational agents in HR+, HER2- breast cancer. LEE011 (CDK4/6 inhibitor), BKM120 (PI3K-pan class I-inhibitor) and BYL719 (PI3K-alpha specific class I inhibitor) in combination with fulvestrant. This is a multi-center, op...
What is the current status of trial NCT02088684?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 70 participants. The study started on 2014-05-19. Estimated completion is 2018-04-17.
What interventions are being tested in trial NCT02088684?
The interventions under investigation include: fulvestrant (DRUG), LEE011 (DRUG), BYL719 (DRUG), BKM120 (DRUG).
Who is sponsoring clinical trial NCT02088684?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02088684's enrollment target sits among peer trials
70 749th of 2000 higher than 1,227 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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