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A Phase III Double-blind Randomised Study Assessing the Efficacy and Safety of Capivasertib + Fulvestrant Versus Placebo + Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2−) Breast Cancer Following Recurrence or Progression On or After Treatment With an Aromatase Inhibitor

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Trial Profile

A Phase III Double-blind Randomised Study Assessing the Efficacy and Safety of Capivasertib + Fulvestrant Versus Placebo + Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2−) Breast Cancer Following Recurrence or Progression On or After Treatment With an Aromatase Inhibitor

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

Latest Information Update: 16 Apr 2025

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At a glance

  • Drugs Capivasertib (Primary) ; Fulvestrant (Primary)
  • Indications Advanced breast cancer; HER2 negative breast cancer; Male breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms CAPItello-291
  • Sponsors AstraZeneca; AstraZeneca AB

Most Recent Events

  • 10 Apr 2025 According to Institute of Cancer Research media release, NICE recommend the targeted breast cancer drug, capivasertib, in combination with fulvestrant, for treating the most common type of advanced breast cancer with specific biomarker alterations (PIK3CA, AKT1 or PTEN).
  • 17 Jul 2024 According to Institute of Cancer Research media release, capivasertib, has been approved by the Medicines & Healthcare products Regulatory Agency (MHRA) for treating the most common type of advanced breast cancer
  • 31 May 2024 According to an AstraZeneca media release, Truqap was approved by Health Canada in January 2024 based on the results from the CAPItello-291 Phase III trial published last year in The New England Journal of Medicine.

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