Ignite Creation Date:
2024-05-06 @ 2:16 PM
Last Modification Date:
2024-10-26 @ 1:27 PM
Study NCT ID:
NCT04262804
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-08-22
First Post:
2020-01-30
Brief Title:
A Study to Evaluate the Efficacy and Safety of Margetuximab Plus Chemotherapy in the Treatment of Chinese Patients With HER2 MBC
Sponsor:
Zai Lab Shanghai Co Ltd
Organization:
Zai Lab Hong Kong Ltd
Study Overview
Official Title:
A Randomized Open-Label Multiple-center Phase II Study to Evaluate the Efficacy and Safety of Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of Chinese Patients With HER2 Metastatic Breast Cancer Who Have Received Prior Anti-HER2 Therapies
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-08
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:
This is a randomized open-label multi-center Phase II clinical study to evaluate the efficacy and safety of margetuximab plus chemotherapy compared with trastuzumab plus chemotherapy in Chinese patients Mainland Hong Kong and Taiwan with advanced HER2 breast cancer who have received at least 2 prior lines of anti-HER2 directed therapy in the metastatic setting mandatory including trastuzumab
The primary endpoint of this study is PFS evaluated by BICR The secondary endpoints are OS PFS evaluated by investigator ORR DoR CBR safety and tolerability the impact of ADA and the popPK profile
The primary endpoint of this study is PFS evaluated by BICR The secondary endpoints are OS PFS evaluated by investigator ORR DoR CBR safety and tolerability the impact of ADA and the popPK profile
Detailed Description:
Approximately 120 Chinese subjects will be enrolled and randomized to treatment group and control group in 11 fashion approximately 60 subjects in each group Eligible subjects are HER2 positive metastatic breast cancer who has received at least 2 prior lines of anti-HER2 directed therapy in the metastatic setting mandatory to have trastuzumab and other anti-HER2 agents eg lapatinib pyrotinib and pertuzumab in case of having received neoadjuvant anti-HER2 therapy in Chinese patients Mainland Hong Kong and Taiwan Subjects should Have received treatment with at least one and no more than three lines of therapy overall in the metastatic setting including anti-HER2 directed therapy and chemotherapy and patients must have progressed on or following the most recent line of therapy based on RECIST 11
Eligible subjects will be randomized 11 to receive margetuximab plus chemotherapy compared with trastuzumab plus chemotherapy The dosage and administering of margetuximab is 15 mgkg IV Q3W Trastuzumab was administered 8 mgkg loading dose 6 mgkg subsequent doses IV Q3W Prior to randomization to either margetuximab or trastuzumab investigators selected one of four backbone chemotherapy regimens given at standard doses capecitabine vinorelbine or gemcitabine Capecitabine and vinorelbine should be selected in priority Gemcitabine could be selected only if capecitabine and vinorelbine were used in previous treatment Subject will receive the treatment until disease progression unacceptable toxicity withdrawal of consent initiation of subsequent anti-tumor treatment therapy or death whichever occurs first Subject is not allowed to crossover after disease progression Randomization was stratified by number of metastatic sites 2 2 and chemotherapy chosen
The definition of HER2 positive is to have at least once 3 by IHC FISH positive or CISH positive in the pathological testretesting Subject should provide original biopsysurgical excision tissue samplelatest follow-up sample after randomization for the centralized test and review when necessary
Eligible subjects will be randomized 11 to receive margetuximab plus chemotherapy compared with trastuzumab plus chemotherapy The dosage and administering of margetuximab is 15 mgkg IV Q3W Trastuzumab was administered 8 mgkg loading dose 6 mgkg subsequent doses IV Q3W Prior to randomization to either margetuximab or trastuzumab investigators selected one of four backbone chemotherapy regimens given at standard doses capecitabine vinorelbine or gemcitabine Capecitabine and vinorelbine should be selected in priority Gemcitabine could be selected only if capecitabine and vinorelbine were used in previous treatment Subject will receive the treatment until disease progression unacceptable toxicity withdrawal of consent initiation of subsequent anti-tumor treatment therapy or death whichever occurs first Subject is not allowed to crossover after disease progression Randomization was stratified by number of metastatic sites 2 2 and chemotherapy chosen
The definition of HER2 positive is to have at least once 3 by IHC FISH positive or CISH positive in the pathological testretesting Subject should provide original biopsysurgical excision tissue samplelatest follow-up sample after randomization for the centralized test and review when necessary
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