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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
355
pyrotinib: 400mg orally daily;
placebo: 400mg orally daily;
trastuzumab:8mg/kg iv load followed by 6mg/kg iv 3-weekly for a total of 4 cycles;
Peking University People's Hospital
Beijing, Beijing Municipality, China
The Fifth Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery evaluated by independent review committee(IRC)
Time frame: through study completion, an average of 1 year
Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery evaluated by sites
Time frame: 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)
Time frame: Following surgery until Year 3
Disease-free Survival (DFS)
Time frame: Following surgery until Year 3
Distance Disease-free Survival (DDFS)
Time frame: Following surgery until Year 3
Objective Response Rate (ORR) during neoadjuvant period
Time frame: Baseline up to cycle 4 (assessed at Baseline, at the time of pre-surgery)up to approximately 12 months
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docetaxel:after the biological window, 100mg/m2 for a total of 4 cycles
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Sun Yet-Sen University Cancer Center
Guangzhou, Guangdong, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The affiliated cancer hospital of Zhengzhou University & Henan Cancer Hospital
Zhengzhou, Henan, China
Huai'an First People's Hospital
Huaian, Jiangsu, China
JiangSu Province Hospital
Nanjing, Jiangsu, China
...and 7 more locations