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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: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT02437318 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 572 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (26% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
PFS was defined as the time from the date of randomization to the date of the first documented progression or death due to any cause. PFS was assessed via a local radiology assessment according to RECIST 1.1. If a patient did not have an event, PFS was censored at the date of last adequate tumor assessment. The PFS distribution was estimated using Kaplan-Meier methodology. Progression was defined as at least a 20% increase in the sum of diameter of all measured target lesions, taking as referen
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 |
What the finished NCT02437318 record still lists
NCT02437318 is an interventional study that assigns participants to a tested intervention. The registered 572 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (26% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02437318 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02437318's enrollment target sits among peer trials
572 663rd of 2000 higher than 1,336 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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