Capivasertib+Fulvestrant vs Placebo+Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic HR+/HER2- Breast Cancer

Titre officiel

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

Sommaire:

Phase III, double-blind, randomised study assessing the efficacy of capivasertib + fulvestrant vs placebo + fulvestrant for the treatment of patients with locally advanced (inoperable) or metastatic HR+/HER2- breast cancer following recurrence or progression on or after AI therapy.

Description de l'essai

Primary Outcome:

  • Progression-Free Survival (PFS) in the overall population
Secondary Outcome:
  • PFS in PIK3CA/AKT1/PTEN-altered subgroup
  • Overall Survival (OS)
  • Investigator assessment of PFS2
  • Response Rate (ORR)
  • Duration of Response (DoR)
  • Clinical Benefit Rate (CBR)
  • ocurrence/frequency of AEs and its relationship to study drugs (safety and tolerability)
  • plasma concentration of capivasertib
  • EORTC QLQ BR23(European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire breast cancer specific module)
  • The EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 items)
  • Time to definitive deterioration of the ECOG (Eastern Cooperative Oncology Group) performance status
Phase III, double-blind, randomised study assessing the efficacy of capivasertib + fulvestrant vs placebo + fulvestrant for the treatment of patients with 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 aromatase inhibitor (AI) therapy.

Voir cet essai sur ClinicalTrials.gov

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