Study of the Molecular Features of Postmenopausal Women With HR+ HER2-negative aBC on First-line Treatment With Ribociclib and Letrozole and, in Patients With a PIK3CA Mutation, on Second-line Treatment With Alpelisib Plus Fulvestrant (BioItaLEE)
A Phase IIIb, Open-label, Local, Multicenter Study of the Molecular Features of Postmenopausal Women With Hormone Receptor-positive (HR+) HER2-negative Advanced Breast Cancer on First-line Treatment With Ribociclib Plus Letrozole and, in Patients With a PIK3CA Mutation, on Second-line Treatment With Alpelisib Plus Fulvestrant (BioItaLEE)
Sponsor: Novartis Pharmaceuticals
Listed as NCT03439046, this PHASE3 trial focuses on Breast Cancer and remains completed. Sponsored by Novartis Pharmaceuticals, it has been updated 25 times since 2018, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.
Status Flow
Change History
25 versions recorded-
Sep 2025 — Present [monthly]
Completed PHASE3
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Sep 2024 — Sep 2025 [monthly]
Completed PHASE3
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Aug 2024 — Sep 2024 [monthly]
Completed PHASE3
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Jul 2024 — Aug 2024 [monthly]
Completed PHASE3
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Mar 2024 — Jul 2024 [monthly]
Completed PHASE3
Status: Active Not Recruiting → Completed
▶ Show 20 earlier versions
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Feb 2024 — Mar 2024 [monthly]
Active Not Recruiting PHASE3
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Jan 2024 — Feb 2024 [monthly]
Active Not Recruiting PHASE3
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Nov 2023 — Jan 2024 [monthly]
Active Not Recruiting PHASE3
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Sep 2023 — Nov 2023 [monthly]
Active Not Recruiting PHASE3
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Aug 2023 — Sep 2023 [monthly]
Active Not Recruiting PHASE3
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Jun 2023 — Aug 2023 [monthly]
Active Not Recruiting PHASE3
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Dec 2022 — Jun 2023 [monthly]
Active Not Recruiting PHASE3
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Nov 2022 — Dec 2022 [monthly]
Active Not Recruiting PHASE3
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Jan 2022 — Nov 2022 [monthly]
Active Not Recruiting PHASE3
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Jun 2021 — Jan 2022 [monthly]
Active Not Recruiting PHASE3
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Mar 2021 — Jun 2021 [monthly]
Active Not Recruiting PHASE3
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Jan 2021 — Mar 2021 [monthly]
Active Not Recruiting PHASE3
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Oct 2020 — Jan 2021 [monthly]
Active Not Recruiting PHASE3
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May 2020 — Oct 2020 [monthly]
Active Not Recruiting PHASE3
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Sep 2019 — May 2020 [monthly]
Active Not Recruiting PHASE3
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Aug 2019 — Sep 2019 [monthly]
Active Not Recruiting PHASE3
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Jun 2019 — Aug 2019 [monthly]
Active Not Recruiting PHASE3
Status: Recruiting → Active Not Recruiting
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Sep 2018 — Jun 2019 [monthly]
Recruiting PHASE3
Status: Not Yet Recruiting → Recruiting
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Jun 2018 — Sep 2018 [monthly]
Not Yet Recruiting PHASE3
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Mar 2018 — Jun 2018 [monthly]
Not Yet Recruiting PHASE3
First recorded
Feb 2018
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Novartis Pharmaceuticals
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
Aviano, Italy , Bari, Italy , Benevento, Italy , Bergamo, Italy , Bologna, Italy , Brescia, Italy , Brindisi, Italy , Candiolo, Italy , Casale Monferrato, Italy , Catania, Italy and 24 more locations