AZD2171 in Addition to Fulvestrant in Patients With Advanced Breast Cancer.

Phase 2 Completed 75 enrolled AstraZeneca

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to determine whether AZD2171 can effectively improve time to tumour progression when added to fulvestrant in patients with advanced hormone sensitive breast cancer who progressed on prior hormonal therapy.

Timeline

Start: 2007-03
Primary completion: 2008-12
Completion: 2016-04

Outcome

Missed primary endpoint

paper Patients treated with cediranib had a numerical advantage in PFS (hazard ratio=0.867, P=0.669; median 223 vs. 112 days, respectively) PMID 23801303 ↗

Publications

Hyams DM, Chan A, de Oliveira C, Snyder R, Vinholes J, Audeh MW, Alencar VM, Lombard J, Mookerjee B, Xu J, Brown K, Klein P. Cediranib in combination with fulvestrant in hormone-sensitive metastatic breast cancer: a randomized Phase II study. Invest New Drugs. 2013 Oct;31(5):1345-54. doi: 10.1007/s10637-013-9991-2. Epub 2013 Jun 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cediranib	Small molecule	45 mg	Oral
Background	Fulvestrant	Small molecule	—	Intramuscular