Ignite Creation Date:
2024-05-06 @ 3:26 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04639986
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-14
First Post:
2020-11-17
Brief Title:
Asian Study of Sacituzumab Govitecan IMMU-132 in HRHER2- Metastatic Breast Cancer MBC
Sponsor:
Gilead Sciences
Organization:
Gilead Sciences
Study Overview
Official Title:
A Phase 3 Asian Study of Sacituzumab Govitecan IMMU-132 Versus Treatment of Physicians Choice TPC in Subjects With Hormonal Receptor-positive HRHuman Epidermal Growth Factor Receptor 2 Negative HER2- Metastatic Breast Cancer MBC Who Have Failed at Least 2 Prior Chemotherapy Regimens
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
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:
The goal of this study is to compare the study drug sacituzumab govitecan-hziy versus doctors treatment of choice in participants with HRHER2- metastatic breast cancer MBC who have failed at least 2 prior chemotherapy regimens
Detailed Description:
Approximately 330 eligible participants will be randomly allocated to one of the following 2 treatment arms in a 11 ratio
Investigational Arm
Sacituzumab Govitecan-hziy 10 mgkg via intravenous IV injection administered on Day 1 and Day 8 21-day cycle
Control Arm
Recommended doses and schedules as per package insert depending on region Eribulin Capecitabine Gemcitabine Vinorelbine Participants will be treated until disease progression as judged by local investigator review development of unacceptable toxicity or withdrawal of consent
Investigational Arm
Sacituzumab Govitecan-hziy 10 mgkg via intravenous IV injection administered on Day 1 and Day 8 21-day cycle
Control Arm
Recommended doses and schedules as per package insert depending on region Eribulin Capecitabine Gemcitabine Vinorelbine Participants will be treated until disease progression as judged by local investigator review development of unacceptable toxicity or withdrawal of consent
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CTR20210096 | REGISTRY | China Drug Clinical Trial Registration and Information Disclosure Platform | None |