Este estudio de fase III, aleatorizado, de 3 brazos, multicéntrico, evaluará la eficacia y seguridad de trastuzumab emtansina (T-DM1) con pertuzumab o trastuzumab emtansina (T-DM1) con placebo de pertuzumab (ciego para pertuzumab), versus la combinación de trastuzumab (Herceptin) más taxano (docetaxel o paclitaxel) en participantes con cáncer de mama HER2 positivo progresivo o recurrente localmente avanzado o metastásico no tratado previamente. Los participantes serán aleatorizados a 1 de 3 brazos de tratamiento (Brazos A, B o C). El Brazo A será abierto, mientras que los Brazos B y C serán ciegos.
75 mg/m2 or 100 mg/m2 intravenously every 3 weeks for a minimum of 6 cycles.
80 mg/m2 intravenously weekly for a minimum of 18 weeks
840 mg intravenously on day 1 of cycle 1 followed by 420 mg intravenously every 3 weeks in subsequent cycles
840 mg intravenously on day 1 of cycle 1 followed by 420 mg intravenously every 3 weeks in subsequent cycles
trastuzumab \[Herceptin\] doses when administered with docetaxel: 8 mg/kg intravenously on cycle 1 followed by 6 mg/kg every 3 weeks in subsequent cycles or trastuzumab (Herceptin) doses when administered with paclitaxel: 4 mg/kg intravenously on day 1 of cycle 1 followed by 2 mg/kg weekly starting on day 8 of cycle 1.
3.6 mg/kg intravenously every 3 weeks
Buenos Aires, Argentina
San Miguel de Tucumán, Argentina