Ignite Creation Date:
2024-05-06 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 12:55 PM
Study NCT ID:
NCT03691051
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-09-25
First Post:
2018-09-28
Brief Title:
A Study of Pyrotinib Plus Capecitabine in Patients With Brain Metastases From HER2-positive Metastatic Breast Cancer
Sponsor:
Henan Cancer Hospital
Organization:
Henan Cancer Hospital
Study Overview
Official Title:
Pyrotinib Plus Capecitabine in Patients With Brain Metastases From HER2-positive Metastatic Breast Cancer a Single-arm Open-label Ahead Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptorsThis 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
Detailed 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 approachesChemotherapy 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 metastasesThus new therapeutic options are urgently needed to improve patientsoutcome 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None