Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06179303
Status:
SUSPENDED
Last Update Posted:
2024-07-11
First Post:
2023-12-08
Brief Title:
Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive HER2-Negative Breast Cancer
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
A Phase II Trial to Evaluate Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive HER2-Negative Breast Cancer
Status:
SUSPENDED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study enrollment temporarily on hold pending availability of the FFNP radiotracer
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial tests the accuracy of functional imaging FFNP-positron emission tomography PETcomputed tomography CT to predict response to abemaciclib plus endocrine therapy Abemaciclib is a drug used to treat certain types of hormone receptor positive HR HER2 negative breast cancer Abemaciclib blocks certain proteins which may help keep tumor cells from growing Endocrine therapy adds blocks or removes hormones that can cause cancer to grow FFNP PET imaging is a form of x-ray that uses FFNP as an imaging agent that may provide more precise information about the location of tumors that light up with FFNP than a PET scan alone can provide
Detailed Description:
OUTLINE
Patients receive FFNP intravenously IV and undergo PETCT imaging at baseline Patients then receive estradiol orally every 8 hours Q8H over a 24-hour period followed again by FFNP IV and PETCT imaging Patients then receive abemaciclib orally PO twice daily BID on days 1-28 of each cycle Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients also receive endocrine therapy ET of the treating physician choice Patients also receive FDG IV and undergo PETCT imaging at baseline with additional diagnostic imaging for tumor assessment every 3 cycles and undergo blood sample collection throughout the study
After study completion of study patients are followed every 3 months
Patients receive FFNP intravenously IV and undergo PETCT imaging at baseline Patients then receive estradiol orally every 8 hours Q8H over a 24-hour period followed again by FFNP IV and PETCT imaging Patients then receive abemaciclib orally PO twice daily BID on days 1-28 of each cycle Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients also receive endocrine therapy ET of the treating physician choice Patients also receive FDG IV and undergo PETCT imaging at baseline with additional diagnostic imaging for tumor assessment every 3 cycles and undergo blood sample collection throughout the study
After study completion of study patients are followed every 3 months
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 |
|---|---|---|---|
| FHIRB0020029 | OTHER | Fred HutchUniversity of Washington Cancer Consortium | None |
| NCI-2022-06409 | REGISTRY | None | None |