A Study of Ipatasertib in Combination With Paclitaxel as a Treatment for Participants With PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple-Negative Breast Cancer or Hormone Receptor-Positive, HER2-Negative Breast Cancer

Official Title

A Double-Blind, Placebo-Controlled, Randomized Phase III Study of Ipatasertib in Combination With Paclitaxel as a Treatment for Patients With PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple-Negative Breast Cancer or Hormone Receptor-Positive, HER2-Negative Breast Cancer

Summary:

This study will evaluate the efficacy of ipatasertib + paclitaxel versus placebo + paclitaxel in participants with histologically confirmed, locally advanced or metastatic triple-negative breast cancer (TNBC) and in participants with locally advanced or metastatic hormone receptor positive (HR+)/ human epidermal growth factor receptor 2 negative (HER2−) breast adenocarcinoma who are not suitable for endocrine therapy.

Trial Description

Primary Outcome:

  • Progression-Free Survival (PFS)
Secondary Outcome:
  • Objective Response Rate (ORR)
  • Duration of Response (DOR)
  • Clinical Benefit Rate (CBR)
  • Overall Survival (OS)
  • Global Health Status (GHS)/Health-Related Quality of Life (HRQoL) Score
  • Time to Deterioration in Pain
  • Incidence and Severity of Adverse Events (AEs)
  • Changes in Vital Signs
  • Changes in Targeted Laboratory Results
  • Plasma Concentration of Ipatasertib and Its Metabolite (G-037720)

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