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Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant in Participants With HR-postitive (HR+), HER2-negative, Advanced Breast Cancer After Treatment With a CDK4/6 Inhibitor and an Aromatase Inhibitor.

Phase 3
Recruiting
Conditions
Breast Cancer
Interventions
Drug: Alpelisib
Drug: Fulvestrant
Drug: Alpelisib-matching placebo
First Posted Date
2021-09-09
Last Posted Date
2025-01-07
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
234
Registration Number
NCT05038735
Locations
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Novartis Investigative Site, Zaragoza, Spain

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

Phase 3
Active, not recruiting
Conditions
Advanced HER2+Breast Cancer
Interventions
First Posted Date
2019-12-23
Last Posted Date
2025-01-07
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
19
Registration Number
NCT04208178
Locations
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Highlands Oncology Group, Fayetteville, Arkansas, United States

๐Ÿ‡บ๐Ÿ‡ธ

University of California LA, Los Angeles, California, United States

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Novartis Investigative Site, Hospitalet de LLobregat, Catalunya, Spain

Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant in Men and Postmenopausal Women With Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment.

Phase 3
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2015-05-07
Last Posted Date
2023-11-18
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
572
Registration Number
NCT02437318
Locations
๐Ÿ‡บ๐Ÿ‡ธ

Lahey Clinic, Burlington, Massachusetts, United States

๐Ÿ‡บ๐Ÿ‡ธ

Virginia Cancer Specialists SC, Fairfax, Virginia, United States

๐Ÿ‡บ๐Ÿ‡ธ

Highlands Oncology Group, Fayetteville, Arkansas, United States

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