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A Phase Ib/III Study to Evaluate the Efficacy and Safety of Afuresertib Plus Fulvestrant in Patients With Locally Advanced or Metastatic HR+/HER2- Breast Cancer Who Failed Standard of Care Therapies

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Trial Profile

A Phase Ib/III Study to Evaluate the Efficacy and Safety of Afuresertib Plus Fulvestrant in Patients With Locally Advanced or Metastatic HR+/HER2- Breast Cancer Who Failed Standard of Care Therapies

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 19 Jun 2024

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At a glance

  • Drugs Afuresertib (Primary) ; Fulvestrant (Primary)
  • Indications Advanced breast cancer; HER2 negative breast cancer; Male breast cancer
  • Focus Proof of concept; Registrational; Therapeutic Use
  • Sponsors Laekna Therapeutics

    • Most Recent Events

    • 13 Jun 2024 Phase has been changed to Phase 3 from 1, this study is now parallel and double-blind, number of treatment arms has been changed to 4 from 2, planned number of patients changed from 20 to 256.
    • 13 Jun 2024 Planned End Date changed from 30 Dec 2024 to 30 Dec 2026.
    • 13 Jun 2024 Planned primary completion date changed from 30 Jun 2023 to 30 Oct 2026.

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