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 (BYLieve)
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 Prior Treatments
Sponsor: Novartis Pharmaceuticals
A PHASE2 clinical study on Breast Cancer, this trial is completed. The trial is conducted by Novartis Pharmaceuticals and has accumulated 55 data snapshots since 2017. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.
Status Flow
Change History
55 versions recorded-
Feb 2026 — Present [monthly]
Completed PHASE2
-
Jan 2026 — Feb 2026 [monthly]
Completed PHASE2
-
Dec 2025 — Jan 2026 [monthly]
Completed PHASE2
-
Oct 2025 — Dec 2025 [monthly]
Completed PHASE2
-
Sep 2025 — Oct 2025 [monthly]
Completed PHASE2
▶ Show 50 earlier versions
-
Aug 2025 — Sep 2025 [monthly]
Completed PHASE2
-
Feb 2025 — Aug 2025 [monthly]
Completed PHASE2
-
Jan 2025 — Feb 2025 [monthly]
Completed PHASE2
Status: Active Not Recruiting → Completed
-
Dec 2024 — Jan 2025 [monthly]
Active Not Recruiting PHASE2
-
Nov 2024 — Dec 2024 [monthly]
Active Not Recruiting PHASE2
-
Sep 2024 — Nov 2024 [monthly]
Active Not Recruiting PHASE2
-
Jul 2024 — Sep 2024 [monthly]
Active Not Recruiting PHASE2
-
Apr 2024 — Jul 2024 [monthly]
Active Not Recruiting PHASE2
-
Mar 2024 — Apr 2024 [monthly]
Active Not Recruiting PHASE2
-
Jan 2024 — Mar 2024 [monthly]
Active Not Recruiting PHASE2
-
Nov 2023 — Jan 2024 [monthly]
Active Not Recruiting PHASE2
-
Jun 2023 — Nov 2023 [monthly]
Active Not Recruiting PHASE2
-
May 2023 — Jun 2023 [monthly]
Active Not Recruiting PHASE2
-
Dec 2022 — May 2023 [monthly]
Active Not Recruiting PHASE2
-
Nov 2022 — Dec 2022 [monthly]
Active Not Recruiting PHASE2
-
Sep 2022 — Nov 2022 [monthly]
Active Not Recruiting PHASE2
-
Jul 2022 — Sep 2022 [monthly]
Active Not Recruiting PHASE2
-
Jun 2022 — Jul 2022 [monthly]
Active Not Recruiting PHASE2
-
May 2022 — Jun 2022 [monthly]
Active Not Recruiting PHASE2
-
Nov 2021 — May 2022 [monthly]
Active Not Recruiting PHASE2
-
Sep 2021 — Nov 2021 [monthly]
Active Not Recruiting PHASE2
-
May 2021 — Sep 2021 [monthly]
Active Not Recruiting PHASE2
Status: Recruiting → Active Not Recruiting
-
Mar 2021 — May 2021 [monthly]
Recruiting PHASE2
-
Jan 2021 — Mar 2021 [monthly]
Recruiting PHASE2
-
Sep 2020 — Jan 2021 [monthly]
Recruiting PHASE2
-
Jul 2020 — Sep 2020 [monthly]
Recruiting PHASE2
-
May 2020 — Jul 2020 [monthly]
Recruiting PHASE2
-
Feb 2020 — May 2020 [monthly]
Recruiting PHASE2
-
Jan 2020 — Feb 2020 [monthly]
Recruiting PHASE2
-
Nov 2019 — Jan 2020 [monthly]
Recruiting PHASE2
-
Oct 2019 — Nov 2019 [monthly]
Recruiting PHASE2
-
Sep 2019 — Oct 2019 [monthly]
Recruiting PHASE2
-
Aug 2019 — Sep 2019 [monthly]
Recruiting PHASE2
-
Jun 2019 — Aug 2019 [monthly]
Recruiting PHASE2
-
Apr 2019 — Jun 2019 [monthly]
Recruiting PHASE2
-
Mar 2019 — Apr 2019 [monthly]
Recruiting PHASE2
-
Feb 2019 — Mar 2019 [monthly]
Recruiting PHASE2
-
Jan 2019 — Feb 2019 [monthly]
Recruiting PHASE2
-
Oct 2018 — Jan 2019 [monthly]
Recruiting PHASE2
-
Aug 2018 — Oct 2018 [monthly]
Recruiting PHASE2
-
Jul 2018 — Aug 2018 [monthly]
Recruiting PHASE2
-
Jun 2018 — Jul 2018 [monthly]
Recruiting PHASE2
-
Mar 2018 — Jun 2018 [monthly]
Recruiting PHASE2
-
Feb 2018 — Mar 2018 [monthly]
Recruiting PHASE2
-
Dec 2017 — Feb 2018 [monthly]
Recruiting PHASE2
-
Nov 2017 — Dec 2017 [monthly]
Recruiting PHASE2
-
Oct 2017 — Nov 2017 [monthly]
Recruiting PHASE2
-
Sep 2017 — Oct 2017 [monthly]
Recruiting PHASE2
-
Jul 2017 — Sep 2017 [monthly]
Recruiting PHASE2
Status: Not Yet Recruiting → Recruiting
-
Feb 2017 — Jul 2017 [monthly]
Not Yet Recruiting PHASE2
First recorded
Eligibility Summary
No eligibility information available.
Contact Information
- Novartis Pharmaceuticals
For direct contact, visit the study record on ClinicalTrials.gov .