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A Phase III, Multicenter, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Versus Alpelisib Plus Fulvestrant in Patients With Hormone Receptor-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Who Progressed During or After CDK4/6 Inhibitor and Endocrine Combination Therapy

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A Phase III, Multicenter, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Versus Alpelisib Plus Fulvestrant in Patients With Hormone Receptor-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Who Progressed During or After CDK4/6 Inhibitor and Endocrine Combination Therapy

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

Latest Information Update: 03 Feb 2025

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At a glance

  • Drugs Fulvestrant (Primary) ; Inavolisib (Primary) ; Alpelisib
  • Indications Adenocarcinoma; Advanced breast cancer; HER2 negative breast cancer; Male breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms INAVO121
  • Sponsors Roche

    • Most Recent Events

    • 29 Jan 2025 Status changed from recruiting to active, no longer recruiting.
    • 04 Jun 2024 According to trial design presented at the 60th Annual Meeting of the American Society of Clinical Oncology, this study is open for enrollment and has randomized 159 patients, while it is targeting 400 patients at nearly 200 sites globally.
    • 04 Jun 2024 Trial design presented at the 60th Annual Meeting of the American Society of Clinical Oncology.

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