common.study.topics.clinical

Testing Experimental Treatment of Breast Cancer

common.study.values.description

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.

common.study.values.location

participant.ui.study.affiliations-map.online-study.header-virtual

participant.ui.study.affiliations-map.online-study.text

participant.ui.study.affiliations-map.legend.locations participant.ui.study.affiliations-map.legend.selected

common.study.values.methods

Pharmaceutical medication involved common.study.methods.has-drugs-yes
Recruiting patients only common.study.methods.is-healthy-yes

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.

participant.views.study.view.additional

participant.views.study.view.scientific-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

common.study.values.clinical-trial-id

NCT04191499

participant.views.study.view.id

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