Hoffmann-La Roche

WO41554

NCT04191499

JCP088

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

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III

Phase

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1st

Line of Therapy

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Advanced / Metastatic

Disease Stage

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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