drugset / Trial / NCT02569801

A Study of GDC-0810 Versus Fulvestrant in Postmenopausal Women With Advanced or Metastatic Breast Cancer Resistant to Aromatase Inhibitor (AI) Therapy

NCT02569801

Phase 2 Terminated 71 enrolled Genentech, Inc.
RandomizedParallel-groupOpen-labelTreatment

Summary

The primary purpose of this study is to evaluate the efficacy, safety, and tolerability of GDC-0810 compared with fulvestrant in postmenopausal women with advanced or metastatic estrogen receptor positive (ER+)/ human epidermal growth factor receptor 2 negative (HER2-) breast cancer resistant to AI therapy. The development of GDC-0810 has been halted by the Sponsor and the enrollment in this study has been discontinued. Participants currently enrolled in the study who are experiencing clinical benefit may continue receiving GDC-0810 as a single agent or fulvestrant until disease progression (PD), unmanageable toxicity, withdrawal of consent, exhaustion of GDC-0810 drug supply, or termination of the study by the Sponsor.

Timeline

Start
2015-12-04
Primary completion
2020-02-28
Completion
2020-02-28

Drugs

EvaluationDrugModalityDoseRoute
Subject BRILANESTRANT Small molecule 600 mg Oral
Comparator Fulvestrant Small molecule 500 mg Intramuscular

Indications