Ignite Creation Date:
2024-05-06 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04717531
Status:
UNKNOWN
Last Update Posted:
2021-06-04
First Post:
2021-01-17
Brief Title:
Pyrotinib as Neoadjuvant Agent for Non-objective Response HER2-positive Early Breast Cancer
Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Organization:
The First Affiliated Hospital with Nanjing Medical University
Study Overview
Official Title:
Pyrotinib as Neoadjuvant Agent for Non-objective Response Patients of HER2-positive Early Breast Cancer Treated by Trastuzumab Pertuzumab and Chemotherapy PYHOPE-BC-104 a Randomized Controlled Phase Ⅱ Trial
Status:
UNKNOWN
Status Verified Date:
2021-06
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:
The study assesses the efficacy of neoadjuvant treatment with pyrotinib and trastuzumab with chemotherapy mainly pathological complete response pCR rates in the breast and axilla
And also assesses side effects event-free survival EFS disease-free survival DFS distant disease-free survival DDFS and objective response rates ORR
And also assesses side effects event-free survival EFS disease-free survival DFS distant disease-free survival DDFS and objective response rates ORR
Detailed Description:
Investigational Medical Products IMPs will be pyrotinib B trastuzumab H pertuzumab P docetaxel T epirubicin E and cyclophosphamide C
Magnetic resonance imaging MRI will be performed at baseline and 2 cycles after neoadjuvant therapy with trastuzumab pertuzumab and docetaxel THP2 Non-objective response patients will be randomly assigned 21 to receive 2 cycles of pyrotinib and trastuzumab with docetaxel followed by 4 cycles of pyrotinib and epirubicin plus cyclophosphamide THB2-ECBepirubicine cyclophosphamide and pyrotinib4 cohort A or 2 cycles of trastuzumab and pertuzumab with docetaxel followed by 4 cycles of epirubicin plus cyclophosphamide THP2-EC4 cohort B
During the neoadjuvant therapy the side effects and all the events were recorded and analyzed After surgery the efficacy of pCR rate and ORR were analyzed And long time follow-up will also be performed to analyze EFS DFS DDFS and ORR
Magnetic resonance imaging MRI will be performed at baseline and 2 cycles after neoadjuvant therapy with trastuzumab pertuzumab and docetaxel THP2 Non-objective response patients will be randomly assigned 21 to receive 2 cycles of pyrotinib and trastuzumab with docetaxel followed by 4 cycles of pyrotinib and epirubicin plus cyclophosphamide THB2-ECBepirubicine cyclophosphamide and pyrotinib4 cohort A or 2 cycles of trastuzumab and pertuzumab with docetaxel followed by 4 cycles of epirubicin plus cyclophosphamide THP2-EC4 cohort B
During the neoadjuvant therapy the side effects and all the events were recorded and analyzed After surgery the efficacy of pCR rate and ORR were analyzed And long time follow-up will also be performed to analyze EFS DFS DDFS and ORR
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