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Clinical Trial Summary

Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors.This study is a single-arm, prospective, open label clinical study of pyrotinib plus capecitabine as the Therapy of brain metastases from HER2-positive metastatic breast cancer.


Clinical Trial Description

Brain metastases occur in 30-50% of patients with metastatic HER2-positive breast cancer. In the case of solitary brain metastases, surgery or stereotactic radiosurgery are the preferred therapeutic approaches.Chemotherapy is used after further progression of disease but it has limited effectiveness. In HER2-positive tumours, trastuzumab therapy has been postulated to be associated with an increased risk of development of brain metastases.Thus new therapeutic options are urgently needed to improve patients'outcome. Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. We designed the study to explore the possibility of pyrotinib plus capecitabine for brain metastases from HER2-positive metastatic breast cancer. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03691051
Study type Interventional
Source Henan Cancer Hospital
Contact
Status Active, not recruiting
Phase Phase 2
Start date November 20, 2018
Completion date December 30, 2024

See also
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Active, not recruiting NCT03080805 - Pyrotinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer. (PHOEBE) Phase 3
Active, not recruiting NCT02422199 - A Study of Pyrotinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+Metastatic Breast Cancer Who Have Prior Received Anthracyclin, Taxane or Trastuzumab Phase 1/Phase 2
Terminated NCT01495884 - The Myocet/Lapatinib Study. ICORG 10-03, V5 Phase 1/Phase 2
Active, not recruiting NCT02973737 - A Study of Pyrotinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Phase 3
Completed NCT04398108 - A Study to Evaluate the Pharmacokinetics of Margetuximab in Chinese Patients With HER2+ MBC Phase 1
Active, not recruiting NCT04681287 - Exploratory Study of Advanced Breast Cancer in HER2 Positive Patients With Failure of Multi-line Therapy Treated by Combination of Inetetamab (Cipterbin) + PD-1 Inhibitor Combined With Utidelone. Phase 2