The primary objective of the study is to study the pharmacokinetics of pyrotinib and docetaxel plus Trastuzumab in HER2 Positive MBC. The secondary objective of the study is to evaluate the safety and efficacy (ORR) of pyrotinib and docetaxel plus Trastuzumab in HER2 Positive MBC.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
97
Docetaxel and trastuzumab once per cycle
Pyrotinib 400/320 mg orally daily
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
Pharmacokinetic parameter: Cmax of pyrotinib and docetaxel
Peak Plasma Concentration (Cmax) of pyrotinib
Time frame: Approximately 2 months
Pharmacokinetic parameter: AUC of pyrotinib and docetaxel
Area under the plasma concentration versus time curve (AUC) of pyrotinib and docetaxel
Time frame: Approximately 2 months
ORR
Objective Response Rate
Time frame: Approximately 17 months
AEs+SAEs
Adverse Events and Serious Adverse Events
Time frame: Approximately 17 months
λz
Time frame: Approximately 6 months
The incidence of≥3 grade diarrhea with different treatment
Time frame: Approximately 17 months
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