Eine randomisierte, doppelbline, placebokontrollierte multizentrische Phase III-Studie mit Everolimus einmal taglich in Kombination mit Trastuzumab und Vinorelbin bei vorbehandelten Frauen mit lokal fortgeschrittenem oder metastasiertem Mammakarzinom und

BOLERO-3 (Breast cancer trials of OraL EveROlimus-3) is a randomized, double-blind, placebo-controlled phase III study of oral everolimus (RAD001) in combination with trastuzumab and vinorelbine in the treatment of women with HER2-overexpressing (HER2+) locally-advanced or metastatic breast cancer previously treated with taxanes and resistant to trastuzumab.
  Participants are randomized to receive either everolimus (RAD001) 5 mg/day orally or placebo, plus weekly vinorelbine 25 mg/m2 IV and weekly trastuzumab 2mg/kg IV following loading dose of 4mg/kg. The BOLERO-3 clinical study will enroll 572 patients globally, who will be randomization 1:1 to everolimus (RAD001) or placebo.   BOLERO-3 Key facts Primary endpoint: PFS Secondary endpoints:   OS   Overall response rate   Time of deterioration of ECOG performance status   Clinical benefit rate   Time to response   Duration of response   Safety   Patient reported outcome (PRO)   Blood levels of everolimus   Plasma levels of vinorelbine   Serum levels of trastuzumab Target enrollment: 572