Conditions: Metastatic Breast Cancer
Keywords: Trastuzumab emtansine MBC Breast cancer HER2-positive breast cancer HER2
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 112
Healthy volunteers: no

Brief summary:
This was a multi-institutional, open-label, single-arm, Phase II study of trastuzumab emtansine (T-DM1) administered by intravenous (IV) infusion to patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC).

Detailed description:

Arms:
arm 1: Patients received trastuzumab emtansine 3.6 mg/kg intravenously on Day 1 of each 21 day cycle for a maximum of 1 year. The total dose was dependent on the patient's weight on Day 1 of each cycle.

Interventions: intervention 1: Trastuzumab emtansine [Kadcyla]
Intervention descriptions: intervention 1: Trastuzumab emtansine was provided in either a liquid or a lyophilized formulation.

Protocol document: