Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant in Men and Postmenopausal Women With Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment.

Official Title

A Phase III Randomized Double-blind, Placebo Controlled Study of Alpelisib in Combination With Fulvestrant for Men and Postmenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment

Summary:

To determine whether treatment with alpelisib plus fulvestrant prolongs progression-free survival compared to fulvestrant and placebo in men and postmenopausal women with hormone receptor positive (HR+), HER2-negative advanced breast cancer, who received prior treatment with an Aromatase Inhibitor either as (neo)adjuvant or for advanced disease.

Trial Description

Primary Outcome:

  • Progression-free survival (PFS) for patients with PIK3CA mutant status
Secondary Outcome:
  • Overall survival (OS) for patients with PI3KCA mutant status
  • Overall response rate (ORR)
  • Time to definitive deterioration of Eastern Cooperative Oncology Group (ECOG) performance status
  • Safety and tolerability of alpelisib in combination with fulvestrant
  • Time to 10% deterioration in the global health status/Quality of Life (QOL) scale score of the EORTC QLQ-C30
  • Plasma concentration-time profile of alpelisib given in combinatio with fulvestrant and appropriate pharmacokinetics (PK) parameters
  • PFS based on radiology assessments and using RECIST 1.1 criteria
  • Progresion free survival (PFS) based on Blinded Independent Review Committee (BIRC)
  • Clinical benefit rate (CBR)
  • Change in the global health status/(QOL) scale score of the EORTC QLQ-C30
  • Summary statistics of fulvestrant and alpelisib plasma concentrations
  • PFS for patients with PIK3CA non-mutant status
  • OS for patients with PIK3CA non-mutant status

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society