click on circles to display study description...
pertuzumab plus trastuzumab (n=2400) vs. trastuzumab (n=2404)
randomized controlled trial
pertuzumab plus trastuzumab plus chemotherapy
pertuzumab: 840 mg IV as a loading dose, followed by 420 mg IV every 3 weeks / trastuzumab: 8mg per kg of body weight IV as a loading dose, followed by 6 mg per kg IV every 3 weeks / --> both beginning at the first cycle of taxane therapy and continuing for a maximum of 18 cycles within 1 year
placebo plus trastuzumab plus chemotherapy
placebo / trastuzumab: 8mg per kg of body weight IV as a loading dose, followed by 6 mg per kg IV every 3 weeks / --> both beginning at the first cycle of taxane therapy and continuing for a maximum of 18 cycles within 1 year
chemotherapy: Anti-HER2 treatment was given in combination with chemotherapy according to one of the following schedules: 3 or 4 cycles (every 3 weeks) of 5-fluorouracil plus either epirubicin or doxorubicin plus cyclophosphamide, followed by 3 or 4 cycles (every 3 weeks) of docetaxel or 12 weekly cycles of paclitaxel; 4 cycles (every 3 weeks or every 2 weeks) of cyclophosphamide plus either doxorubicin or epirubicin, followed by either 4 cycles (every 3 weeks) of docetaxel or 12 weekly cycles of paclitaxel; or 6 cycles (every 3 weeks) of docetaxel plus carboplatin
breast cancer - adjuvant
Exclusion criteria: Patients with previous invasive breast cancer, nonbreast cancer within 5 years before randomization, any previous chemotherapy or radiotherapy for cancer, any previous anti-HER2 therapy or other previous anticancer biologic therapy or immunotherapy
double blind
549 centers across 43 countries
P3 / controlled at 5% 2-sided, use of a hierarchical testing procedure: if IDFS is significant, following endpoints will be tested in the following order: IDFS including second primary non-breast cancer, DFS, OS. For OS, 3 IA: 1st at IDFS final p<0.00001, 2nd at 4-5 yr after last randomization: p=0.0027, 3rd at 7-8 yr after last randomization p=0.0139, final at 640 OS events (9-10yr) p = 0.0453
IDFS and DFS were significantly higher in the pertuzumab group compare to the placebo group.
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
powered by vis.js Network