Clinical trial
Study of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as…
NCT04208178 · Novartis Pharmaceuticals, Industry · Active, not recruiting
Key facts
| NCT number | NCT04208178 |
|---|---|
| Title | Study of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA Mutation |
| Official title | EPIK-B2: A Two Part, Phase III, Multicenter, Randomized (1:1), Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA… |
| Acronym | EPIK-B2 |
| Lead sponsor | Novartis Pharmaceuticals, Industry |
| Status | Active, not recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Advanced HER2+Breast Cancer |
| Intervention type | Drug |
| Interventions | Alpelisib, Alpelisib matching Placebo, Trastuzumab, Pertuzumab |
| Enrollment | 19 |
| Start date | Jul 16, 2020 |
| Primary completion | Feb 26, 2027 |
| Completion | Feb 26, 2027 |
| First posted | Dec 23, 2019 |
| Last update posted | Feb 2, 2026 |
| Countries | Belgium, China, France, Italy, Malaysia, Spain, United States |
At a glance
- 10–99 Study sites
- No 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: