Neoadjuvant Study of Pyrotinib in Combination With Trastuzumab in Patients With HER2 Positive Breast Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

355

Participants

Timeline

Start Date

July 24, 2018

Primary Completion Date

January 31, 2024

Study Completion Date

January 31, 2024

Conditions
HER2-positive Breast Cancer
Interventions
DRUG

Pyrotinib

pyrotinib: 400mg orally daily;

DRUG

Placebo Oral Tablet

placebo: 400mg orally daily;

DRUG

Trastuzumab

trastuzumab:8mg/kg iv load followed by 6mg/kg iv 3-weekly for a total of 4 cycles;

DRUG

Docetaxel

docetaxel:after the biological window, 100mg/m2 for a total of 4 cycles

Trial Locations (17)

100044

Peking University People's Hospital, Beijing

100071

The Fifth Medical Center of Chinese PLA General Hospital, Beijing

200032

Fudan University Shanghai Cancer Center, Shanghai

210029

JiangSu Province Hospital, Nanjing

223001

Huai'an First People's Hospital, Huaian

250000

Shandong Cancer Hospital, Jinan

266100

The Affiliated Hospital Of Qingdao University, Qingdao

310003

The First Affiliated Hospital Zhejiang University School of Medicine, Hangzhou

310005

Zhejiang Cancer Hospital, Hangzhou

310009

The Second Affiliated Hospital Zhejiang University School of Medicine, Hangzhou

350001

Fujian Medical University Union Hospital, Fuzhou

450000

The affiliated cancer hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou

510010

Sun Yet-Sen University Cancer Center, Guangzhou

510080

Guangdong Provincial People's Hospital, Guangzhou

510289

Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou

710004

The Second Affiliated Hospital Of Xi'an Jiaotong University, Xian

050000

The Fourth Hospital of Hebei Medical University, Shijiazhuang

All Listed Sponsors
lead

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

NCT03588091 - Neoadjuvant Study of Pyrotinib in Combination With Trastuzumab in Patients With HER2 Positive Breast Cancer | Biotech Hunter | Biotech Hunter