Ignite Creation Date:
2024-05-06 @ 12:59 PM
Last Modification Date:
2024-10-26 @ 1:07 PM
Study NCT ID:
NCT03901339
Status:
COMPLETED
Last Update Posted:
2023-11-18
First Post:
2019-03-26
Brief Title:
Study of Sacituzumab Govitecan-hziy Versus Treatment of Physicians Choice in Participants With HRHER2- Metastatic Breast Cancer
Sponsor:
Gilead Sciences
Organization:
Gilead Sciences
Study Overview
Official Title:
Phase 3 Study of Sacituzumab Govitecan IMMU-132 Versus Treatment of Physicians Choice TPC in Subjects With Hormonal Receptor-Positive HR Human Epidermal Growth Factor Receptor 2 HER2 Negative Metastatic Breast Cancer MBC Who Have Failed at Least Two Prior Chemotherapy Regimens
Status:
COMPLETED
Status Verified Date:
2024-09
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:
TROPiCS-02
Brief Summary:
The primary objective of this study is to assess and compare the efficacy and safety of sacituzumab govitecan-hzi versus treatment of physicians choice TPC in participants with hormonal receptor-positive HR human epidermal growth factor receptor 2 HER2- negative metastatic breast cancer MBC
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2018-004201-33 | EUDRACT_NUMBER | None | None |