Ignite Creation Date:
2024-07-17 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06470347
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-03-24
Brief Title:
A Real-World Study of Pyrrolitinib Maleate Tablets for HER-2-Positive Early or Locally Advanced Breast Cancer After Adjuvant Trastuzumab Therapy
Sponsor:
Zunyi Medical College
Organization:
Zunyi Medical College
Study Overview
Official Title:
A Real-World Study of Pyrrolitinib Maleate Tablets for HER-2-Positive Early or Locally Advanced Breast Cancer After Adjuvant Trastuzumab Therapy
Status:
RECRUITING
Status Verified Date:
2024-06
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:
Purpose of the Study
Primary Study Objective
To evaluate the efficacy of pyrrolitinib maleate tablets in the treatment of HER-2-positive early or locally advanced breast cancer after adjuvant therapy with trastuzumab
Secondary Research Objectives
To evaluate the safety of pyrrolitinib maleate tablets in the treatment of HER-2 positive early or locally advanced breast cancer after trastuzumab adjuvant therapy
Study Endpoints Primary Study Endpoint
Invasive disease free survival iDFS
Secondary Study Endpoints
1 overall survival OS
2 disease-free survival DFS
3 distant metastasis free survival DDFS
4 safety Study Population Patients with early or locally advanced HER-2 positive breast cancer with clinical stage 0-III who have received prior neoadjuvant or adjuvant therapy where the neoadjuvant andor adjuvant treatment phase has been completed at least 24 weeks 8 dosing cycles of trastuzumab therapy and the time interval between the end of the last course of trastuzumab therapy and entry into the study must be 1 year Study Design Single-arm multicenter interventional study Administration Pyrrolitinib The recommended dose of this product is 400 mg orally once daily within 30 minutes after breakfast for 52 weeks approximately one year
Dose adjustments may be made in accordance with this protocol taking into account adverse reactions in subjects Each consecutive suspension of piretinib during the course of the study should not exceed 14 days prophylactic use of medications for the treatment of diarrhea is permitted during the course of treatment multiple suspensions of study medication due to adverse events are permitted and doses of piretinib that are missed for any reason will not be made up
Primary Study Objective
To evaluate the efficacy of pyrrolitinib maleate tablets in the treatment of HER-2-positive early or locally advanced breast cancer after adjuvant therapy with trastuzumab
Secondary Research Objectives
To evaluate the safety of pyrrolitinib maleate tablets in the treatment of HER-2 positive early or locally advanced breast cancer after trastuzumab adjuvant therapy
Study Endpoints Primary Study Endpoint
Invasive disease free survival iDFS
Secondary Study Endpoints
1 overall survival OS
2 disease-free survival DFS
3 distant metastasis free survival DDFS
4 safety Study Population Patients with early or locally advanced HER-2 positive breast cancer with clinical stage 0-III who have received prior neoadjuvant or adjuvant therapy where the neoadjuvant andor adjuvant treatment phase has been completed at least 24 weeks 8 dosing cycles of trastuzumab therapy and the time interval between the end of the last course of trastuzumab therapy and entry into the study must be 1 year Study Design Single-arm multicenter interventional study Administration Pyrrolitinib The recommended dose of this product is 400 mg orally once daily within 30 minutes after breakfast for 52 weeks approximately one year
Dose adjustments may be made in accordance with this protocol taking into account adverse reactions in subjects Each consecutive suspension of piretinib during the course of the study should not exceed 14 days prophylactic use of medications for the treatment of diarrhea is permitted during the course of treatment multiple suspensions of study medication due to adverse events are permitted and doses of piretinib that are missed for any reason will not be made up
Detailed Description:
None
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