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NCT00454805, 2013 NCT00454805

cediranib plus fulvestrant (n=-9) vs. fulvestrant (n=-9)

randomized controlled trial

Studied treatment

cediranib plus fulvestrant
cediranib: PO 45mg/day / fulvestrant: IM 500mg day 1 and 250mg days 15, 29 and every 28 days thereafter

Control treatment

fulvestrant
fulvestrant: IM 500mg day 1 and 250mg days 15, 29 and every 28 days thereafter

Patients

la/mBC - HR-positive - 1st line (L1)

exclusion criteria: prior biological therapy (except trastuzumab),fulvestrant treatment, >1 course of prior systemic cytotoxicchemotherapy for MBC

Method

double blind

from 19 centers in Australia, Brazil and the USA

P2 / PFS at 1-sided at 10% significance level

Remark