This is a randomized, double-blinded, multicenter phase 3 clinical trial to evaluate the efficacy and safety of pyrotinib plus trastuzumab plus docetaxel versus placebo plus trastuzumab plus docetaxel in patients who have HER2 positive metastatic breast cancer and have not received systemic anticancer therapy for advanced disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
590
Pyrotinib 400mg orally daily until progressive disease
Placebo 400mg orally daily until progressive disease
Cancer Institute and Hospital,Chinese Academy of Medical Science
Beijing, Beijing Municipality, China
PFS
Progression Free Survival
Time frame: Approximately 42 months
AEs+SAEs
Adverse Events and Serious Adverse Events
Time frame: From the first drug administration to within 28 days for the last treatment
OS
Overall Survival
Time frame: Up to 2 years
ORR
Objective Response Rate
Time frame: Approximately 42 months
DoR
Duration of Objective Response
Time frame: Approximately 42 months
CBR
Clinical Benefit rate
Time frame: From the start of randomization to 6 months
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