NCT03153163

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

A Phase I Study of Pharmacokinetics and Safety of Trastuzumab Emtansine in Chinese Patients With Logically Advanced Inoperable or Metastatic HER2-Positive Breast Cancer Who Have Received Prior Trastuzumab Based Therapy

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Breast Neoplasms

Interventions

Type	Name	Description
DRUG	Trastuzumab Emtansine	Trastuzumab emtansine will be administered by IV infusion at a dose of 3.6 milligrams per kilogram (mg/kg) of body weight, every three weeks (Q3W) until death, disease progression or unmanageable toxicity.

Timeline

• Start date: 2017-06-20
• Primary completion: 2018-09-27
• Completion: 2018-09-27
• First posted: 2017-05-15
• Last updated: 2018-11-23

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study