Testing Experimental Treatment of Breast Cancer
“A Study Evaluating the Efficacy and Safety of GDC-0077 + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer”
This study will evaluate the efficacy, safety, and pharmacokinetics of GDC-0077 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.
Drug - GDC-0077
Participants will receive oral GDC-0077 on Days 1-28 of each 28-day cycle.
Drug - Placebo
Participants will receive oral placebo on Days 1-28 of each 28-day cycle.
Drug - Palbociclib
Participants will receive oral palbociclib on Days 1-21 of each 28-day cycle.
Drug - Fulvestrant
Participants will receive intramuscular (IM) fulvestrant approximately every 4 weeks.
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