NCT02569801

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

A Phase II, Open-Label, Randomized Study of GDC-0810 Versus Fulvestrant in Postmenopausal Women With Advanced or Metastatic ER+ /HER2- Breast Cancer Resistant to Aromatase Inhibitor Therapy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Fulvestrant	Fulvestrant at a dose of 500 mg as two intramuscular injections will be administered on Day 1 and Day 15 of Cycle 1, and on Day 1 of each subsequent 28-day cycle.
DRUG	GDC-0810	GDC-0810 will be administered as tablets at a dose of 600 mg orally once daily.

Timeline

• Start date: 2015-12-04
• Primary completion: 2020-02-28
• Completion: 2020-02-28
• First posted: 2015-10-07
• Last updated: 2021-04-23
• Results posted: 2021-04-23

Locations

44 sites across 6 countries: United States, Australia, Germany, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study