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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 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 1,147 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01610284
The ClinicalTrials.gov registry entry for NCT01610284 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,147 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Fulvestrant is the first listed.
NCT01610284 reports 0 study locations.
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.
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