Efficacy and Safety of Trastuzumab Emtansine in Chinese Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Locally Advanced or Metastatic Breast Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

351

Participants

Timeline

Start Date

April 24, 2017

Primary Completion Date

November 23, 2018

Study Completion Date

March 14, 2023

Conditions
Breast Cancer
Interventions
BIOLOGICAL

Trastuzumab Emtansine

Trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) was administered intravenously on Day 1 of each 21-day cycle.

DRUG

Lapatinib

Lapatinib 1250 mg was administered orally once per day of each 21-day cycle.

DRUG

Capecitabine

Capecitabine 1000 milligrams per square meter (mg/m\^2) was administered orally twice daily on Days 1-14 of each 21-day cycle.

Trial Locations (18)

100006

Beijing Hospital, Beijing

100071

The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA), Beijing

100142

Beijing Cancer Hospital, Beijing

110042

Liaoning cancer Hospital & Institute, Shenyang

130021

the First Hospital of Jilin University, Changchun

132013

Jilin Cancer Hospital, Changchun

150081

Harbin Medical University Cancer Hospital, Harbin

200025

Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital), Shanghai

200120

Fudan University Shanghai Cancer Center, Shanghai

210008

Jiangsu Province Hospital, Nanjing

211100

Jiangsu Cancer Hospital, Nanjing

213003

Changzhou First People's Hospital, Changzhou

300060

Tianjin Cancer Hospital, Tianjin

310009

The Second Affiliated Hospital of Zhejiang University College, Hangzhou

310022

Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department, Hangzhou

350001

Fujian Medical University Union Hospital, Fuzhou

610041

West China Hospital, Sichuan University, Chengdu

710061

First Affiliated Hospital of Medical College of Xi'an Jiaotong University, Xi'an

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT03084939 - Efficacy and Safety of Trastuzumab Emtansine in Chinese Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Locally Advanced or Metastatic Breast Cancer | Biotech Hunter | Biotech Hunter