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NCT02437318 · ClinicalTrials.gov registry record · Phase 3
Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant in Men and Postmenopausal Women With Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment.
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 572
- Enrollment target
NCT02437318 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 572 participants.
The verdict
NCT02437318, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 572 participants
- Enrollment target
Study Summary
To determine whether treatment with alpelisib plus fulvestrant prolonged progression-free survival (PFS) compared to fulvestrant and placebo in men and postmenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor-2 (HER2)-negative advanced breast cancer, who received prior treatment with an aromatase Inhibitor (AI) either as (neo)adjuvant or for advanced disease.
Interventions
- DRUG Placebo
- DRUG Fulvestrant
- DRUG Alpelisib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 572 participants |
| Start Date | 2015-07-23 |
| Est. Completion | 2023-06-09 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02437318
The ClinicalTrials.gov registry entry for NCT02437318 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 572 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 Placebo is the first listed.
NCT02437318 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02437318 about?
NCT02437318 is a clinical study titled "Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant in Men and Postmenopausal Women With Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment.". To determine whether treatment with alpelisib plus fulvestrant prolonged progression-free survival (PFS) compared to fulvestrant and placebo in men and postmenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor-2 (HER2)-negative advanced breast cancer, who rece...
What is the current status of trial NCT02437318?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 572 participants. The study started on 2015-07-23. Estimated completion is 2023-06-09.
What interventions are being tested in trial NCT02437318?
The interventions under investigation include: Placebo (DRUG), Fulvestrant (DRUG), Alpelisib (DRUG).
Who is sponsoring clinical trial NCT02437318?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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