Ignite Creation Date:
2024-05-06 @ 9:23 AM
Last Modification Date:
2024-10-26 @ 12:14 PM
Study NCT ID:
NCT02973737
Status:
UNKNOWN
Last Update Posted:
2022-10-25
First Post:
2016-11-22
Brief Title:
A Study of Pyrotinib Plus Capecitabine in Patients With HER2 Metastatic Breast Cancer
Sponsor:
Jiangsu HengRui Medicine Co Ltd
Organization:
Jiangsu HengRui Medicine Co Ltd
Study Overview
Official Title:
Pyrotinib Plus Capecitabine Versus Placebo Plus Capecitabine in Patients With HER2 Metastatic Breast Cancera Randomised Double-blind Multicentre Phase 3 Trial
Status:
UNKNOWN
Status Verified Date:
2022-10
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 double blind active-controlled parallel design study of the combination of pyrotinib in combination with capecitabine versus placebo plus capecitabine in HER2 MBC patients who have prior received anthracyclin taxane and trastuzumab
Patients will be randomized in a 21 ratio to one of the following treatment arms
Arm A pyrotinib 400 mg once daily capecitabine 1000 mgm2 twice daily Arm B placebo 400 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
Patients in control group can be provide pyrotinib treatment when they progressed after the placebo plus capecitabine treatment
Patients will be randomized in a 21 ratio to one of the following treatment arms
Arm A pyrotinib 400 mg once daily capecitabine 1000 mgm2 twice daily Arm B placebo 400 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
Patients in control group can be provide pyrotinib treatment when they progressed after the placebo plus capecitabine treatment
Detailed Description:
This study is a phase 3 randomized multi-center multinational double blind active-controlled parallel design study of the combination of pyrotinib in combination with capecitabine versus placebo plus capecitabine in HER2 MBC patients who have prior received anthracyclin taxane and trastuzumab
Patients will be randomized in a 21 ratio to one of the following treatment arms
Arm A pyrotinib 400 mg once daily capecitabine 1000 mgm2 twice daily Arm B placebo 400 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
Efficacy assessments will be performed at screening every 6 weeks until cycle 18 every 12 weeks thereafter
Patients in control group can be provide pyrotinib treatment when they progressed after the placebo plus capecitabine treatment Pyrotinb will be administrated until the patients reached progress again or wit
Patients will be randomized in a 21 ratio to one of the following treatment arms
Arm A pyrotinib 400 mg once daily capecitabine 1000 mgm2 twice daily Arm B placebo 400 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
Efficacy assessments will be performed at screening every 6 weeks until cycle 18 every 12 weeks thereafter
Patients in control group can be provide pyrotinib treatment when they progressed after the placebo plus capecitabine treatment Pyrotinb will be administrated until the patients reached progress again or wit
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