Conditions: Metastatic Breast Cancer
Keywords: HER2-positive breast cancer MBC Trastuzumab emtansine Herceptin T-DM1
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 54
Healthy volunteers: no

Brief summary:
This is a phase I, multicenter, open-label, dose-escalation study of single-agent trastuzumab-MCC-DM1 administered by intravenous (IV) infusion in patients with HER2-positive metastatic breast cancer (MBC) who have previously received trastuzumab. The study will assess the safety, tolerability, and pharmacokinetics of trastuzumab-MCC-DM1 and determine the dose and schedule to be used in Phase II.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: trastuzumab-MCC-DM1
Intervention descriptions: intervention 1: Intravenous escalating dose

Protocol document: