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bevacizumab plus trastuzumab plus docetaxel (n=216) vs. trastuzumab plus docetaxel (n=208)
randomized controlled trial
bevacizumab plus docetaxel plus trastuzumab
bevacizumab: 15mg/kg IV / docetaxel 100mg/m² IV / trastuzumab: 8mg/kg loading dose followed by 6mg/kg IV (all agents were administered every 3 weeks)
docetaxel plus trastuzumab
docetaxel 100mg/m² IV / trastuzumab: 8mg/kg loading dose followed by 6mg/kg IV (all agents were administered every 3 weeks)
la/mBC - HER2 positive - 1st Line (L1)
open label
72 sites in 16 countries
P3 / PFS at 0.05 / the trial was not powered for OS
The study did not met its primary endpoint, PFS was not difference with addition of bevacizumab.
cediranib plus fulvestrant (n=-9) vs. fulvestrant (n=-9)
randomized controlled trial
cediranib plus fulvestrant
cediranib: PO 45mg/day / fulvestrant: IM 500mg day 1 and 250mg days 15, 29 and every 28 days thereafter
fulvestrant
fulvestrant: IM 500mg day 1 and 250mg days 15, 29 and every 28 days thereafter
la/mBC - HR-positive - 1st line (L1)
exclusion criteria: prior biological therapy (except trastuzumab),fulvestrant treatment, >1 course of prior systemic cytotoxicchemotherapy for MBC
double blind
from 19 centers in Australia, Brazil and the USA
P2 / PFS at 1-sided at 10% significance level
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