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ALPelisib INdia Safety STudy (ALPINIST): A Phase IV, Prospective, Multicenter, Open-label, Non-comparative, Interventional Study to Assess the Safety of Alpelisib Plus Fulvestrant, in Men and Post-menopausal Women With HR Positive, HER2-negative, Advanced Breast Cancer (aBC) With a PIK3CA Mutation, Whose Disease Has Progressed on or After Endocrine Based Treatment

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Trial Profile

ALPelisib INdia Safety STudy (ALPINIST): A Phase IV, Prospective, Multicenter, Open-label, Non-comparative, Interventional Study to Assess the Safety of Alpelisib Plus Fulvestrant, in Men and Post-menopausal Women With HR Positive, HER2-negative, Advanced Breast Cancer (aBC) With a PIK3CA Mutation, Whose Disease Has Progressed on or After Endocrine Based Treatment

Status: Recruiting
Phase of Trial: Phase IV

Latest Information Update: 22 Mar 2024

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At a glance

  • Drugs Alpelisib (Primary) ; Fulvestrant (Primary)
  • Indications Advanced breast cancer; HER2 negative breast cancer; Male breast cancer
  • Focus Adverse reactions
  • Acronyms ALPINIST
  • Sponsors Novartis Pharmaceuticals

    • Most Recent Events

    • 19 Mar 2024 Planned End Date changed from 15 Nov 2024 to 3 Nov 2025.
    • 19 Mar 2024 Planned primary completion date changed from 15 Nov 2024 to 3 Nov 2025.
    • 02 Dec 2022 New trial record

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