Clinical trial
Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant or…
NCT03056755 · Novartis Pharmaceuticals, Industry · Completed
Key facts
| NCT number | NCT03056755 |
|---|---|
| Title | Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole, Based on Prior Endocrine Therapy, in Patients With PIK3CA Mutant, HR+, HER2- Advanced Breast Cancer Who Have Progressed on or After Prior Treatments |
| Official title | BYLieve: A Phase II, Multicenter, Open-label, Three-cohort, Non- Comparative Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole in Patients With PIK3CA Mutant, Hormone Receptor (HR) Positive, HER2-negative Advanced Breast Cancer (aBC), Who Have Progressed on or After… |
| Acronym | BYLieve |
| Lead sponsor | Novartis Pharmaceuticals, Industry |
| Status | Completed |
| Phase | Phase 2 |
| Study type | Interventional |
| Conditions | Breast Cancer |
| Intervention type | Drug |
| Interventions | Alpelisib, Fulvestrant, Letrozole, Goserelin, Leuprolide |
| Enrollment | 383 |
| Start date | Aug 29, 2017 |
| Primary completion | Jun 14, 2021 |
| Completion | Nov 12, 2024 |
| First posted | Feb 17, 2017 |
| Last update posted | Jan 13, 2026 |
| Countries | Argentina, Belgium, Canada, Chile, Denmark, France, Germany, India, Israel, Italy, Japan, Mexico and 7 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.
About ClinicalTrials.gov studies
ClinicalTrials.gov is the U.S. National Library of Medicine's registry of clinical studies conducted around the world. Contact and investigator details are not shown here.
Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: