drugset / Trial / NCT04367090

Pharmacokinetic Study of Pyrotinib and Docetaxel in Combination With Trastuzumab in Patients With HER2 Metastatic Breast Cancer

NCT04367090

Phase 1 Completed 97 enrolled Jiangsu HengRui Medicine Co., Ltd.
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2020-05-28
Primary completion
2022-08-10
Completion
2023-05-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Docetaxel Small molecule
Subject Pyrotinib Small molecule 320 mg Oral
Subject Pyrotinib Small molecule 400 mg Oral
Subject Trastuzumab Monoclonal antibody

Indications