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This is a Multicenter, Single Arm, Open-label, run-in Phase Ib / Roll-over Phase II Study of Tucatinib in Combination With Alpelisib in Subjects With PIK3CA-mutant HER2-positive Locally Advanced Unresectable or Metastatic Breast Cancer

Trial Profile

This is a Multicenter, Single Arm, Open-label, run-in Phase Ib / Roll-over Phase II Study of Tucatinib in Combination With Alpelisib in Subjects With PIK3CA-mutant HER2-positive Locally Advanced Unresectable or Metastatic Breast Cancer

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 18 Mar 2025

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At a glance

  • Drugs Alpelisib (Primary) ; Tucatinib (Primary) ; Fulvestrant
  • Indications Advanced breast cancer; HER2 positive breast cancer
  • Focus Adverse reactions; Therapeutic Use

Most Recent Events

  • 04 Jun 2024 Interim results(As of January 11, 2024, n=6 pts) analyzing tucatinib combined with PI3Ka inhibitor alpelisib in HER2+ PIK3CA-mutated metastatic breast cancer , presented at the 60th Annual Meeting of the American Society of Clinical Oncology
  • 04 Aug 2023 Planned primary completion date changed from 30 Jun 2023 to 30 Aug 2024.
  • 10 Dec 2022 Trial design presented at the 45th Annual San Antonio Breast Cancer Symposium

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