Study of Anastrozole +/- AZD8931 in Postmenopausal Women With Endocrine Therapy Naive Breast Cancer

Summary

The main purpose of this study is to compare progression free survival in patients treated with AZD8931 given in combination with anastrozole versus anastrozole alone. The secondary objective is to investigate the safety and tolerability of AZD8931 given in combination with anastrozole.

Timeline

Start

2010-06

Primary completion

2013-01

Completion

2013-01

Outcome

Missed primary endpoint

Stopped: “Futility”

registry AZD8931 40mg + Anastrozole 1mg vs Placebo + Anastrozole 1mg; p = 0.485; Hazard Ratio (HR) 1.16 (95% CI 0.77 to 1.75); Log Rank NCT01151215 ↗

registry AZD8931 20mg + Anastrozole 1mg vs Placebo + Anastrozole 1mg; p = 0.135; Hazard Ratio (HR) 1.37 (95% CI 0.91 to 2.06); Log Rank NCT01151215 ↗

Publications

• Johnston S, Basik M, Hegg R, Lausoontornsiri W, Grzeda L, Clemons M, Dreosti L, Mann H, Stuart M, Cristofanilli M. Inhibition of EGFR, HER2, and HER3 signaling with AZD8931 in combination with anastrozole as an anticancer approach: Phase II randomized study in women with endocrine-therapy-naive advanced breast cancer. Breast Cancer Res Treat. 2016 Nov;160(1):91-99. doi: 10.1007/s10549-016-3979-5. Epub 2016 Sep 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Anastrozole	Other / unclassified	1 mg	Oral
Subject	SAPITINIB	Small molecule	20 mg	Oral
Subject	SAPITINIB	Small molecule	40 mg	Oral

Indications