SAFIR-PI3K A Phase II Randomized Maintenance Trial Comparing Alpelisib and Fulvestrant Versus Chemotherapy in PIK3CA Mutated Advanced Breast Cancer (SAFIR-PI3K)
A Phase II Randomized Trial Comparing Alpelisib and Fulvestrant Versus Chemotherapy as Maintenance Therapy in Patients With PIK3CA Mutated Advanced Breast Cancer
Sponsor: UNICANCER
Terminated
Study was halted Prematurely for low recruitment.
Listed as NCT03386162, this PHASE2 trial focuses on Breast Cancer, PI3K, Alpelisib and remains terminated or withdrawn. Sponsored by UNICANCER, it has been updated 13 times since 2018, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.
Status Flow
Change History
13 versions recorded-
Sep 2025 — Present [monthly]
Terminated PHASE2
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Sep 2024 — Sep 2025 [monthly]
Terminated PHASE2
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Jul 2024 — Sep 2024 [monthly]
Terminated PHASE2
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Dec 2022 — Jul 2024 [monthly]
Terminated PHASE2
Status: Active Not Recruiting → Terminated
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Apr 2022 — Dec 2022 [monthly]
Active Not Recruiting PHASE2
▶ Show 8 earlier versions
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Oct 2021 — Apr 2022 [monthly]
Active Not Recruiting PHASE2
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Jan 2021 — Oct 2021 [monthly]
Active Not Recruiting PHASE2
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Sep 2020 — Jan 2021 [monthly]
Active Not Recruiting PHASE2
Status: Suspended → Active Not Recruiting
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May 2020 — Sep 2020 [monthly]
Suspended PHASE2
Status: Recruiting → Suspended
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Nov 2019 — May 2020 [monthly]
Recruiting PHASE2
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Mar 2019 — Nov 2019 [monthly]
Recruiting PHASE2
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Nov 2018 — Mar 2019 [monthly]
Recruiting PHASE2
Status: Not Yet Recruiting → Recruiting
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Jan 2018 — Nov 2018 [monthly]
Not Yet Recruiting PHASE2
First recorded
Eligibility Summary
No eligibility information available.
Contact Information
- UNICANCER
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
Angers, France , Avignon, France , Bordeaux, France , Caen, France , La Roche-sur-Yon, France , Limoges, France , Lyon, France , Marseille, France , Montpellier, France , Rennes, France and 4 more locations