Ignite Creation Date:
2024-10-25 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06570031
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-07-31
Brief Title:
ONO-4578-06Phase I Study of ONO-4578 and Letrozole Plus CDK4 6 Inhibitors in Breast Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
ONO-4578-06 Phase I Open-label Non-blind First-line Endocrine Therapy With ONO-4578 and Standard Treatment Letrozole and CDK46 Inhibitors Palbociclib or Abemaciclib in Patients With Metastatic or Recurrent Postmenopausal Hormone Receptor-positive HER2-negative Breast Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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 multicenter open-label non-controlled phase I study to investigate the tolerability and safety of ONO-4578 used in combination with standard-of-care letrozole and a CDK46 inhibitor palbociclib or Abemaciclib as first-line endocrine therapy in postmenopausal patients with metastatic or recurrent hormone receptor-positive HER2-negative breast cancer
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None