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pertuzumab plus trastuzumab (n=129) vs. trastuzumab (n=129)
randomized controlled trial
pertuzumab plus trastuzumab plus an AI (letrozole or anastrozole)
pertuzumab: IV 840 mg and 8 mg/kg loading doses followed by 420 mg / trastuzumab: IV 6 mg/kg maintenance doses / anastrozole: PO 1mg/day or letrozole: PO 2.5mg/day
trastuzumab plus an AI (letrozole or anastrozole)
trastuzumab: IV 6 mg/kg maintenance doses / anastrozole: PO 1mg/day or letrozole: PO 2.5mg/day
investigator could decide to administered chemotherapy: docetaxel and paclitaxel IV
la/mBC - HER2 positive - 1st Line (L1)
open label
80 sites in 8 countries
P2 / PFS at 2-sided at 0.05 / no SAP
pertuzumab plus trastuzumab plus docetaxel (n=402) vs. trastuzumab plus docetaxel (n=406)
randomized controlled trial
pertuzumab plus trastuzumab plus docetaxel
pertuzumab: fixed loading dose of 840 mg IV, followed by 420 mg IV every 3 weeks until disease progression / trastuzumab: loading dose of 8 mg/kg of body weight IV, followed by a maintenance dose of 6 mg per kg IV every 3 weeks until disease progression / docetaxel: every 3 weeks at a starting dose of 75 mg per square meter IV (increase possible to100mg if the side-effect profile was acceptable)
placebo plus trastuzumab plus docetaxel
placebo IV / trastuzumab: loading dose of 8 mg/kg of body weight IV, followed by a maintenance dose of 6 mg per kg IV every 3 weeks until disease progression / docetaxel: every 3 weeks at a starting dose of 75 mg per square meter IV (increase possible to100mg if the side-effect profile was acceptable)
la/mBC - HER2 positive - 1st Line (L1)
Exclusion criteria: therapy for metastatic breast cancer, central nervous system metastases.
double blind
204 centers in 25 countries
P3 / The overall type I error rate for the analysis of primary endpoint of PFS, OS and ORR will be controlled at 5% at 2-sided, using the fixed sequence testing procedure, in this order. / 2 IA for OS.
The addition of pertuzumab to trastuzumab and docetaxel increase significantly the PFS and the OS
pertuzumab plus trastuzumab plus docetaxel (n=-9) vs. trastuzumab plus docetaxel (n=-9)
randomized controlled trial
pertuzumab plus trastuzumab plus docetaxel
pertuzumab: IV 840 mg loading dose,followed by 420 mg every 3 weeks / trastuzumab: IV 8 mg/kgloading dose, then 6 mg/kg every 3 weeks / docetaxel: IV 75 mg/m2 every 3 weeks
placebo plus trastuzumab plus docetaxel
placebo matching pertuzumab / trastuzumab: IV 8 mg/kgloading dose, then 6 mg/kg every 3 weeks / docetaxel: IV 75 mg/m2 every 3 weeks
la/mBC - HER2 positive - 1st Line (L1)
double blind
15 centres in China
P3 / statistical testing is considered exploratory
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