Ignite Creation Date:
2024-05-06 @ 2:42 PM
Last Modification Date:
2024-10-26 @ 1:36 PM
Study NCT ID:
NCT04407988
Status:
UNKNOWN
Last Update Posted:
2021-10-13
First Post:
2020-05-25
Brief Title:
Pyrotinib in Combination With Letrozole in Patients With HER2-Positive ER-Positive Metastatic Breast Cancer
Sponsor:
Hunan Cancer Hospital
Organization:
Hunan Cancer Hospital
Study Overview
Official Title:
Phase II Study of Pyrotinib in Combination With Letrozole in Patients With HER2-Positive ER-Positive Metastatic Breast Cancer
Status:
UNKNOWN
Status Verified Date:
2021-10
Last Known Status:
RECRUITING
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:
This is a prospective single-arm multi-center clinical study of pyrotinib in combination With letrozole in patients With HER2-Positive ER-Positive metastatic breast cancer Our aim was to explore the efficacy and safety of pyrotinib combined with letrozole in patients with HER2-positive ER-positive metastatic breast cancer
Detailed Description:
ERHER2 metastatic breast cancer is a special subtype of HER2 breast cancer General guidelines recommend chemotherapy combined with HER2-targeted therapy for this subtype of patients However for the highly selected patients with ER- positiveHER2-positive ABC ET anti-HER2 therapy could be chosen as first-line therapy And Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors Therefore this study is planned to enroll 86 patients with HER2-positive ER-positive metastatic breast cancer receiving first-line treatment with pyrotinib and letrozole The main purpose was to evaluate the efficacy and safety of pyrotinib combined with letrozole in patients with HER2-positive ER-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