Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06254690
Status:
RECRUITING
Last Update Posted:
2024-02-12
First Post:
2024-01-28
Brief Title:
The Dosing Regimen of Pyrotinib in HER2-positive Advanced First-line Breast Cancer a Phase II Clinical Study
Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Organization:
The First Affiliated Hospital with Nanjing Medical University
Study Overview
Official Title:
Safety and Efficacy of Pyrotinib in Transition From a Low-dose to Normal-dose Regimen in HER2-positive Advanced First-line Breast Cancer a Multicenter Open Phase II Clinical Study
Status:
RECRUITING
Status Verified Date:
2024-02
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:
Evaluate the safety and efficacy of Pyrotinib in the transition from low-dose to normal-dose regimen for HER2-positive advanced first-line breast cancer
Detailed Description:
This study is planned to include 102 patients with HER2-positive advanced breast cancer meeting the admission criteria between 2023-12-01 and 2024-11-01 Statistical software will be used by the randomization officers for 11 allocation to pyrotinib dose increasing trial group and normal pyrotinib dose control group
The primary endpoint of this study was grade 3 treatment-emergent diarrhea incidence during the first 2 cycles according to Common Terminology Criteria for Adverse Events version 50 and secondary endpoints were adverse effects of pyrotinib during the study efficacy progression-free survival and overall survival and patient-reported outcome
The primary endpoint of this study was grade 3 treatment-emergent diarrhea incidence during the first 2 cycles according to Common Terminology Criteria for Adverse Events version 50 and secondary endpoints were adverse effects of pyrotinib during the study efficacy progression-free survival and overall survival and patient-reported outcome
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