Ignite Creation Date:
2024-05-06 @ 4:00 AM
Last Modification Date:
2024-10-26 @ 11:41 AM
Study NCT ID:
NCT02422199
Status:
UNKNOWN
Last Update Posted:
2018-07-09
First Post:
2015-04-16
Brief Title:
A Study of Pyrotinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2Metastatic Breast Cancer Who Have Prior Received Anthracyclin Taxane or Trastuzumab
Sponsor:
Jiangsu HengRui Medicine Co Ltd
Organization:
Jiangsu HengRui Medicine Co Ltd
Study Overview
Official Title:
A Study of Pyrotinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2Metastatic Breast Cancer Who Have Prior Received Anthracyclin Taxane or Trastuzumab
Status:
UNKNOWN
Status Verified Date:
2018-07
Last Known Status:
ACTIVE_NOT_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:
Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors This study is a randomized multi-center multinational open-label active-controlled parallel design study of the combination of pyrotinib plus capecitabine versus the combination of lapatinib plus capecitabine in HER2 MBC patients who have prior received anthracyclin taxane or trastuzumab Patients will be stratified by weather have prior use of trastuzumab and randomized in a 11 ratio to one of the following treatment arms
Arm A pyrotinib 400 mg once daily capecitabine 1000 mgm2 twice daily
Arm B lapatinib 1250 mg once daily capecitabine 1000 mgm2 twice daily Patients will receive either arm of therapy until the occurrence of death disease progression unacceptable toxicity or other specified withdrawal criterion
Arm A pyrotinib 400 mg once daily capecitabine 1000 mgm2 twice daily
Arm B lapatinib 1250 mg once daily capecitabine 1000 mgm2 twice daily Patients will receive either arm of therapy until the occurrence of death disease progression unacceptable toxicity or other specified withdrawal criterion
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None