Ignite Creation Date:
2024-05-06 @ 3:54 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04791384
Status:
RECRUITING
Last Update Posted:
2023-07-27
First Post:
2020-12-30
Brief Title:
Phase IbII Trial of Abemaciclib and Elacestrant in Patients With Brain Metastasis Due to HRHer2- Breast Cancer
Sponsor:
Criterium Inc
Organization:
Criterium Inc
Study Overview
Official Title:
Multicenter Open Label Phase IbII Trial of Abemaciclib and Elacestrant in Patients With Brain Metastasis Due to HRHer2- Breast Cancer
Status:
RECRUITING
Status Verified Date:
2023-07
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 multi-institutional single arm open label Phase IbII study of abemaciclib in combination with elacestrant in patients with HRHer2- breast cancer metastatic to the brain Patients may have received up to two prior lines of systemic chemotherapy for locally advanced or metastatic disease There will be no limit on prior use of endocrine therapy including aromatase inhibitors tamoxifen and fulvestrant given a documented clinical benefit of elacestrant in this setting
Detailed Description:
This is a multi-institutional Phase IbII study in patients with HRHer2- breast cancer metastatic to the brain Patients may have received up to two prior lines of systemic chemotherapy for locally advanced or metastatic disease There will be no limit on prior use of endocrine therapy including aromatase inhibitors tamoxifen and fulvestrant given a documented clinical benefit of elacestrant in this setting Single agent abemaciclib at a dose of 150 mg twice a day and elacestrant at a dose of 400mg day will be administered to all patients with allowances for up to 2 dose reductions due to treatment related toxicities Patients will be evaluated for treatment emergent adverse events AEs during study participation and toxicity will be assessed according to the National Cancer Institute NCI Common Terminology Criteria for Adverse Events Version 50 After accrual of first 10 patients the accrual will be halted and safety analysis phase IB will be performed If response to the combination therapy will be documented in 2 or less patients accrual will be stopped If at least 3 patients will have a documented response to therapy accrual will continue to complete Stage 2
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