Conditions: Breast Cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 153
Healthy volunteers: no

Brief summary:
This single-arm open-label study assessed the safety, feasibility, and efficacy of trastuzumab emtansine (T-DM1) after the completion of anthracycline-based adjuvant/neoadjuvant chemotherapy in patients with early HER2-positive breast cancer. Patients received T-DM1 3.6 mg/kg intravenously on Day 1 of each 3-week cycle, for up to 17 cycles.

Detailed description:

Arms:
arm 1: Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.

Interventions: intervention 1: Trastuzumab emtansine
Intervention descriptions: intervention 1: Trastuzumab emtansine was provided as a single-use lyophilized formulation in a glass vial.

Protocol document: