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 (INAVO120)

Status:

Recruiting

III

Phase

1st

Line of Therapy

Advanced / Metastatic

Disease Stage

Biomarker(s)

HER2-, ER+, PIK3CA

Investigational

Product

GDC-0077

Selective PI3Kα-mutant inhibitor (p.o.)

Treatment Arms

o Experimental: GDC-0077 + Palbociclib + Fulvestrant

o Placebo Comparator: Placebo + Palbociclib + Fulvestrant