Ignite Creation Date:
2024-05-06 @ 9:50 AM
Last Modification Date:
2024-10-26 @ 12:20 PM
Study NCT ID:
NCT03080805
Status:
UNKNOWN
Last Update Posted:
2020-06-18
First Post:
2017-03-03
Brief Title:
Pyrotinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2 Metastatic Breast Cancer PHOEBE
Sponsor:
Jiangsu HengRui Medicine Co Ltd
Organization:
Jiangsu HengRui Medicine Co Ltd
Study Overview
Official Title:
A Randomised Open-label Parallel Controlled Multicentre Phase 3 Clinical Trial of Pyrotinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2 Metastatic Breast Cancer
Status:
UNKNOWN
Status Verified Date:
2020-06
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 randomizedopen-labelmulti-centeractive-controlled parallel design study of the combination of pyrotinib and capecitabine versus Lapatinib plus capecitabine in HER2 MBC patients who have prior received taxane and trastuzumabPatients will be randomized in a 11 ratio to one of the following treatment armsArm A pyrotinib 400 mg once daily capecitabine 1000 mgm2 twice dailyArm B Lapatinib 1250 mg once daily capecitabine 1000 mgm2 twice dailyPatients will receive either arm of therapy until disease progression unacceptable toxicity or withdrawalof consent
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None