Ignite Creation Date:
2024-05-06 @ 7:19 PM
Last Modification Date:
2024-10-26 @ 3:05 PM
Study NCT ID:
NCT05977036
Status:
RECRUITING
Last Update Posted:
2024-05-07
First Post:
2023-07-27
Brief Title:
BettER Biomarker Driven Early Therapeutic Selection in Patients With HR HER2- Metastatic or Unresectable Breast Cancer
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
BettER Biomarker Driven Early Therapeutic Selection in Patients With HR HER2- Metastatic or Unresectable Breast Cancer
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective study to assess the impact of biomarker driven early therapeutic switching and delayed imaging with the incorporation of DiviTum serum TK1 activity DiviTum TKa in patients with HR positive HER-2 negative metastatic or unresectable breast cancer Patients will receive first-line treatment with a CDK46 inhibitor CDK46i and endocrine therapy All patients will have blood drawn for thymidine kinase activity TKa testing at baseline and at C1D15 Patients who are found to have a lack of TKa suppression at C1D15 will be recommended to switch to an alternative therapy Patients with suppressed C1D15 TKa levels will continue on CDK46i and endocrine therapy until clinical progression Patients with TKa which remains suppressed will be recommended to delay restaging scans from 24 weeks to 36 weeks
The investigators hypothesize that a patients TKa level at C1D15 is prognostic for progression-free survival PFS on a CDK46 inhibitor and early therapeutic switching in patients with a lack of C1D15 TKa suppression will be associated with prolonged PFS
The investigators hypothesize that a patients TKa level at C1D15 is prognostic for progression-free survival PFS on a CDK46 inhibitor and early therapeutic switching in patients with a lack of C1D15 TKa suppression will be associated with prolonged PFS
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None