Neoadjuvant Study of Pyrotinib in Combination With Trastuzumab in Patients With HER2 Positive Breast Cancer
- Conditions
- HER2-positive Breast Cancer
- Interventions
- Registration Number
- NCT03588091
- Lead Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Brief Summary
This is a randomised, double-blind multicenter Phase III study for evaluating the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus docetaxel versus placebo and trastuzumab plus docetaxel given as neoadjuvant treatment in HER2 positive early stage or locally advanced breast cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 355
- female patients, 18 years ≤ age ≤ 75 years；
- Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1
- Histologically confirmed invasive breast cancer（early stage or locally advanced）:Primary tumour greater than 2 cm diameter
- HER2 positive (HER2+++ by IHC or FISH+)
- Known hormone receptor status.
- Cardiovascular:Baseline left ventricular ejection fraction (LVEF)≥55% measured by ECHO
- Signed informed consent form (ICF)
- metastatic disease (Stage IV) or inflammatory breast cancer
- Previous or current history of malignant neoplasms, except for curatively treated:Basal and squamous cell carcinoma of the skin,Carcinoma in situ of the cervix.
- clinically relevant cardiovascular disease:Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110);
- Unable or unwilling to swallow tablets.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description arm2 Placebo Oral Tablet placebo plus trastuzumab and docetaxel arm1 Pyrotinib Pyrotinib Plus trastuzumab and docetaxel arm1 Trastuzumab Pyrotinib Plus trastuzumab and docetaxel arm1 Docetaxel Pyrotinib Plus trastuzumab and docetaxel arm2 Trastuzumab placebo plus trastuzumab and docetaxel arm2 Docetaxel placebo plus trastuzumab and docetaxel
- Primary Outcome Measures
Name Time Method Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery evaluated by independent review committee(IRC) through study completion, an average of 1 year
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery evaluated by sites Approximately 4 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 2 weeks after Cycle 4,each cycle is 21 days) Event-free survival(EFS) Following surgery until Year 3 Disease-free Survival (DFS) Following surgery until Year 3 Distance Disease-free Survival (DDFS) Following surgery until Year 3 Objective Response Rate (ORR) during neoadjuvant period Baseline up to cycle 4 (assessed at Baseline, at the time of pre-surgery)up to approximately 12 months
Trial Locations
- Locations (17)
The Fourth Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
Huai'an First People's Hospital
🇨🇳Huaian, Jiangsu, China
The Affiliated Hospital Of Qingdao University
🇨🇳Qingdao, Shandong, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China
The Fifth Medical Center of Chinese PLA General Hospital
🇨🇳Beijing, Beijing, China
The affiliated cancer hospital of Zhengzhou University & Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
Peking University People's Hospital
🇨🇳Beijing, Beijing, China
The Second Affiliated Hospital Of Xi'an Jiaotong University
🇨🇳Xian, Shanxi, China
JiangSu Province Hospital
🇨🇳Nanjing, Jiangsu, China
The First Affiliated Hospital Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China
Fujian Medical University Union Hospital
🇨🇳Fuzhou, Fujian, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
Guangdong Provincial People's Hospital
🇨🇳Guangzhou, Guangdong, China
Sun Yet-Sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China
Shandong Cancer Hospital
🇨🇳Jinan, Shandong, China
The Second Affiliated Hospital Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China