Conditions: Breast Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1095
Healthy volunteers: no

Brief summary:
This randomized, 3-arm, multicenter, phase III study will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) with pertuzumab or trastuzumab emtansine (T-DM1) with pertuzumab-placebo (blinded for pertuzumab), versus the combination of trastuzumab (Herceptin) plus taxane (docetaxel or paclitaxel) in participants with HER2-positive progressive or recurrent locally advanced or previously untreated metastatic breast cancer. Participants will be randomized to 1 of 3 treatment arms (Arms A, B or C). Arm A will be open-label, whereas Arms B and C will be blinded.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: docetaxel intervention 2: paclitaxel intervention 3: pertuzumab intervention 4: pertuzumab-placebo intervention 5: trastuzumab [Herceptin] intervention 6: trastuzumab emtansine
Intervention descriptions: intervention 1: 75 mg/m2 or 100 mg/m2 intravenously every 3 weeks for a minimum of 6 cycles. intervention 2: 80 mg/m2 intravenously weekly for a minimum of 18 weeks intervention 3: 840 mg intravenously on day 1 of cycle 1 followed by 420 mg intravenously every 3 weeks in subsequent cycles intervention 4: 840 mg intravenously on day 1 of cycle 1 followed by 420 mg intravenously every 3 weeks in subsequent cycles intervention 5: 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. intervention 6: 3.6 mg/kg intravenously every 3 weeks

Protocol document: