drugset / Trial / NCT03153163

Study of the Pharmacokinetics and Safety of Trastuzumab Emtansine in Chinese Participants With Locally Advanced Inoperable or Metastatic HER2+ Breast Cancer

NCT03153163

Phase 1 Completed 11 enrolled Hoffmann-La Roche
NaSingle-groupOpen-labelTreatment

Summary

This is an open-label Phase I study of single-agent trastuzumab emtansine administered by intravenous (IV) infusion. The study will characterize the pharmacokinetics of trastuzumab emtansine and its relevant analytes and the safety of trastuzumab emtansine in Chinese participants with human epidermal growth factor receptor 2 (HER2)-positive locally advanced/metastatic breast cancer (LA/MBC).

Timeline

Start
2017-06-20
Primary completion
2018-09-27
Completion
2018-09-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Trastuzumab emtansine Other / unclassified 3.6 mg/kg Intravenous

Indications