Ignite Creation Date:
2024-05-06 @ 4:16 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04923542
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2021-06-08
Brief Title:
Stereotactic Radiation Abemaciclib in the Management of HRHER2- Breast Cancer Brain Metastases
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 Stereotactic Radiation and Abemaciclib in the Management of Hormone Receptor Positive HER2 Negative Breast Cancer Brain Metastases
Status:
RECRUITING
Status Verified Date:
2024-07
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:
This is a single arm study of abemaciclib and endocrine therapy with stereotactic radiosurgery SRS among patients with hormone receptor HRHER2- metastatic breast cancer brain metastases
Detailed Description:
The study is designed as a prospective single-arm nonrandomized open-label phase III trial of abemaciclib and endocrine therapy with stereotactic radiosurgery SRS among patients with hormone receptor HRHER2- metastatic breast cancer brain metastases Treatment will be initiated with one week of abemaciclib followed by stereotactic radiation to sites of brain metastases or post-operative cavities with continued abemaciclib Safety will be monitored initially by a 33 design This will be followed by a phase 2 study to evaluate intracranial progression free survival PFS If unexpected neurologic toxicities are noted the dose of radiation therapy will be modified
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