Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06616987
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-19
Brief Title:
Prevention of Sacituzumab Govitecan-related Neutropenia in Patients With Metastatic Triple Nagative Breast Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Multicenter Open-label Single Arm Phase II Clinical Trial Utilizing a Pegylated Formulation of G-CSF to Mitigate Neutropenia in Patients With Metastatic Triple-Negative Breast Cancer mTNBC Receiving Sacituzumab Govitecan SG
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Prevention of Sacituzumab Govitecan-related Neutropenia in Patients with metastatic Triple Nagative Breast Cancer who have received at least one and no more than two prior standard of care chemotherapy regimens
Detailed Description:
Sacituzumab Govitecan group
- Sacituzumab Govitecan 10mgkg IV on CnD1 and D8 Pegfilgrastim 6mg SC QD on CnD9
- Sacituzumab Govitecan 10mgkg IV on CnD1 and D8 Pegfilgrastim 6mg SC QD on CnD9
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