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A Phase II, Single Arm, Non-randomized Study of Alpelisib (BYL719) in Combination With Continued Endocrine Therapy Following Progression on Endocrine Therapy in Hormone Receptor Positive, HER2 Negative, PIK3CA Mutant Metastatic Breast Cancer

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Trial Profile

A Phase II, Single Arm, Non-randomized Study of Alpelisib (BYL719) in Combination With Continued Endocrine Therapy Following Progression on Endocrine Therapy in Hormone Receptor Positive, HER2 Negative, PIK3CA Mutant Metastatic Breast Cancer

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 05 Jan 2026

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At a glance

  • Drugs Alpelisib (Primary) ; Aromatase inhibitors (Primary) ; Fulvestrant (Primary)
  • Indications Advanced breast cancer; HER2 negative breast cancer; Male breast cancer
  • Focus Therapeutic Use

Most Recent Events

  • 02 Jan 2026 Planned End Date changed from 1 Jan 2026 to 1 May 2026.
  • 02 Jan 2026 Status changed from recruiting to active, no longer recruiting.
  • 30 Oct 2024 Planned End Date changed from 1 Jan 2025 to 1 Jan 2026.

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