Ignite Creation Date:
2024-05-06 @ 3:18 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04588545
Status:
RECRUITING
Last Update Posted:
2024-05-03
First Post:
2020-10-07
Brief Title:
Radiation Therapy Followed by Intrathecal TrastuzumabPertuzumab in HER2 Breast Leptomeningeal Disease
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
Phase III Study of Radiation Therapy Followed by Intrathecal TrastuzumabPertuzumab in the Management of HER2 Breast Leptomeningeal Disease
Status:
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:
The purpose of this study is to find out if radiation therapy followed by intrathecal trastuzumab and pertuzumab is safe and will result in improved survival in HER2 positive breast cancer which has metastasized to the leptomeninges
Detailed Description:
The study is designed as a prospective single-arm nonrandomized open-label phase III trial of radiation therapy RT followed by intrathecal IT trastuzumabpertuzumab in the management of HER2 breast leptomeningeal disease LMD Treatment will be initiated with RT whole brain RT WBRT andor focal brainspine RT followed by IT trastuzumabpertuzumab
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 |
|---|---|---|---|
| ML41590 | OTHER | Genetech | None |