Ignite Creation Date:
2024-05-06 @ 1:23 PM
Last Modification Date:
2024-10-26 @ 1:13 PM
Study NCT ID:
NCT04001621
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2022-12-08
First Post:
2019-06-27
Brief Title:
Pyrotinib in Combination With Capecitabine in Patients With Trastuzumab-resistant HER2-positive Advanced Breast Cancer
Sponsor:
Fudan University
Organization:
Fudan University
Study Overview
Official Title:
Phase II Study of Pyrotinib in Combination With Capecitabine in Patients With Trastuzumab-resistant HER2-positive Advanced Breast Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2022-12
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:
Trastuzumab resistance which is a common therapeutic challenge in HER2 positive metastatic breast cancer is not fully understood Pyrotinib is an oral tyrosine kinase inhibitor targeting EGFR HER-2 and HER-4 receptors More general inhibition of ErbB family with pyrotinib could provide additional benefit This study is designed to evaluate the efficacy and safety of pyrotinib in combination with capecitabine in patients with HER2 positive locally advanced or metastatic breast cancer who had early failure on or after trastuzumab treatment
Detailed Description:
A multi-center one-arm open label design study which is planned to enroll 100 patients with trastuzumab-resistant HER2-positive advanced 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