A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer

Official Title

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of GDC-0077 Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer

Summary:

This study will evaluate the efficacy, safety, and pharmacokinetics of inavolisib in combination with palbociclib and fulvestrant compared with placebo plus palbociclib and fulvestrant in patients with PIK3CA-mutant, hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer whose disease progressed during treatment or within 12 months of completing adjuvant endocrine therapy and who have not received prior systemic therapy for metastatic disease.

Trial Description

Primary Outcome:

• Progression-Free Survival (PFS)

• Objective Response Rate (ORR)
• Best Overall Response Rate (BOR)
• Duration of Response (DOR)
• Clinical Benefit Rate (CBR)
• Overall Survival (OS)
• Time to Deterioration (TTD) in Pain
• TTD in Physical Function
• TTD in Role Function
• TTD in Global Health Status
• Percentage of Participants with Adverse Events
• Plasma Concentration of Inavolisib
• Plasma Concentration of Palbociclib
• Plasma Concentration of Fulvestrant

View this trial on ClinicalTrials.gov