Ignite Creation Date:
2024-05-06 @ 1:40 PM
Last Modification Date:
2024-10-26 @ 1:18 PM
Study NCT ID:
NCT04088110
Status:
UNKNOWN
Last Update Posted:
2019-09-12
First Post:
2019-09-11
Brief Title:
Pyrotinib Combined With Trastuzumab Plus Aromatase Inhibitor in Treatment of Breast Cancer
Sponsor:
Fuzhou General Hospital
Organization:
Fuzhou General Hospital
Study Overview
Official Title:
Pyrotinib Maleate Combined With Trastuzumab Plus Aromatase Inhibitor in the First-line Treatment of Advanced HER2-positiveHR-positive Breast Cancer Phase II Study
Status:
UNKNOWN
Status Verified Date:
2019-09
Last Known Status:
NOT_YET_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 study is a single-arm open-label phase II study comparing the efficacy and safety of pyrotinib plus trastuzumab and aromatase inhibitors in the treatment of HR hormone receptorHER2 human epidermal growth factor receptor 2 MBC and inoperable LABC patients
Detailed Description:
This is a exploratory single-arm open-labelmulticenter phase II trial Our primary purpose is to compare that PFS of patients with pyrotinib plus trastuzumab and AI for HER2-positive and hormone receptor-positive MBC or locally advanced breast cancer LABC
In treatment period patients will be administrated pyrotinib plus trastuzumab and aromatase inhibitors every 21 days for 1 cycle until disease progression toxicity intolerance withdrawal of informed consent patients judged must be terminated study termination
The imaging evaluation was performed according to the RECIST 11 criteria every 6 weeks
In treatment period patients will be administrated pyrotinib plus trastuzumab and aromatase inhibitors every 21 days for 1 cycle until disease progression toxicity intolerance withdrawal of informed consent patients judged must be terminated study termination
The imaging evaluation was performed according to the RECIST 11 criteria every 6 weeks
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