Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06561022
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-21
Brief Title:
Precision Treatment of HR HER2- Advanced Breast Cancer Based on SNF Molecular Subtyping
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Precision Treatment of HR HER2- Advanced Breast Cancer Based on SNF Molecular Subtyping
Status:
NOT_YET_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:
abemaSNF13
Brief Summary:
To explore the efficacy and safety of Everolimus SNF1 subtype or Fluzoparib SNF3 subtype combined with Fulvestrant and Abemaciclib vs Fulvestrant combined with Abemaciclib in patients with HRHER2- breast cancer of SNF1SNF3 subtype who have progressed after CDK 46 inhibitor treatment
Detailed Description:
This is a randomized controlled open-label phase II study to explore the efficacy and safety of a three-drug combination of Everolimus or Fluzoparib plus Fulvestrant and Abemaciclib compared to a two-drug combination of Fulvestrant plus Abemaciclib in patients with HR HER2-advanced breast cancer of SNF1SNF3 subtype who have progressed after CDK 46 inhibitor treatment The study consists of Safety Lead-in phase which aims to explore the safety and preliminary efficacy of the three-drug combination and phase II which aims to explore the efficacy of the three-drug combination
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