Clinical trial
Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant in Men and…
NCT02437318 · Novartis Pharmaceuticals, Industry · Completed
Key facts
| NCT number | NCT02437318 |
|---|---|
| Title | 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. |
| Official title | A Phase III Randomized Double-blind, Placebo Controlled Study of Alpelisib in Combination With Fulvestrant for Men and Postmenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment |
| Acronym | SOLAR-1 |
| Lead sponsor | Novartis Pharmaceuticals, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Breast Cancer |
| Intervention type | Drug |
| Interventions | Fulvestrant, Alpelisib, Placebo |
| Enrollment | 572 |
| Start date | Jul 23, 2015 |
| Primary completion | Jun 12, 2018 |
| Completion | Jun 9, 2023 |
| First posted | May 7, 2015 |
| Last update posted | Feb 13, 2025 |
| Countries | Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Czechia, France, Germany, Greece and 19 more |
At a glance
- 100–999 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: