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NCT01610284 · ClinicalTrials.gov registry record · Phase 3
Phase III Study of BKM120/Placebo With Fulvestrant in Postmenopausal Patients With Hormone Receptor Positive HER2-negative Locally Advanced or Metastatic Breast Cancer Refractory to Aromatase Inhibitor
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,147
- Enrollment target
NCT01610284: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT01610284 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 1,147 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (49% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01610284, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,147 participants
- Enrollment target
Study Summary
This study was a multi-center, randomized, double-blind, placebo controlled Phase III study to determine the efficacy and safety of treatment with buparlisib plus fulvestrant versus fulvestrant plus placebo in postmenopausal women with hormone Receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative), locally advanced or metastatic breast cancer (MBC) whose disease has progressed on or after aromatase inhibitor (AI) treatment.
Primary Outcome
Progression Free Survival (PFS) is defined as the time from date of randomization to the date of first radiologically documented progression or death due to any cause. If a patient did not progress or die at the time of the analysis data cut-off or start of new antineoplastic therapy, PFS was censored at the date of the last adequate tumor assessment before the earliest of the cut-off date or the start date of additional anti-neoplastic therapy. Progression is defined using Response Evaluation C
Interventions
- DRUG Fulvestrant
- DRUG BKM120
- DRUG BKM120 matching placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,147 participants |
| Start Date | 2012-08-07 |
| Est. Completion | 2019-04-19 |
| Phase | Phase 3 |
What the finished NCT01610284 record still lists
NCT01610284 is an interventional study that assigns participants to a tested intervention. Its 1,147 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (49% higher).
The record links to 0 conditions, and to 3 interventions - of which Fulvestrant is the first listed.
NCT01610284 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01610284 about?
NCT01610284 is a clinical study titled "Phase III Study of BKM120/Placebo With Fulvestrant in Postmenopausal Patients With Hormone Receptor Positive HER2-negative Locally Advanced or Metastatic Breast Cancer Refractory to Aromatase Inhibitor". This study was a multi-center, randomized, double-blind, placebo controlled Phase III study to determine the efficacy and safety of treatment with buparlisib plus fulvestrant versus fulvestrant plus placebo in postmenopausal women with hormone Receptor-positive (HR-positive), human epidermal growth ...
What is the current status of trial NCT01610284?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,147 participants. The study started on 2012-08-07. Estimated completion is 2019-04-19.
What interventions are being tested in trial NCT01610284?
The interventions under investigation include: Fulvestrant (DRUG), BKM120 (DRUG), BKM120 matching placebo (DRUG).
Who is sponsoring clinical trial NCT01610284?
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 NCT01610284's enrollment target sits among peer trials
1,147 242nd of 2000 higher than 1,759 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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