Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06375707
Status:
RECRUITING
Last Update Posted:
2024-04-19
First Post:
2023-12-28
Brief Title:
Efficacy and Safety of Ribociclib in Combination With NSAI Versus Physicians Choice of Chemotherapy Sequential Endocrine Therapy in HRHER2- Advanced Breast Cancer
Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Organization:
The First Affiliated Hospital with Nanjing Medical University
Study Overview
Official Title:
Efficacy and Safety of Ribociclib in Combination With NSAI Versus Physicians Choice of Chemotherapy Sequential Endocrine Therapy in HRHER2- Advanced Breast Cancer a Phase II Randomised Controlled Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-04
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:
Evaluate the efficacy and safety of Ribociclib in combination with NSAI versus physicians choice of chemotherapy sequential endocrine therapy in HRHER2- advanced breast cancer
Detailed Description:
The main goal of this clinical trial is to compare in the efficacy of Ribociclib in combination with NSAI versus physicians choice of chemotherapy sequential endocrine therapy in HRHER2- advanced breast cancer and evaluate the PCR DFSOS and safety of the subjects The main question it aims is comparing the efficacy and safety of first-line application of CDK46 inhibitors combined with initial endocrine therapy versus sequential endocrine therapy after chemotherapy induction therapy in HRHER2-advanced breast cancer with rapidly progressive disease
This study is planned to include 144 patients with HRHER2-advanced breast cancer with rapidly progressive disease between November 2023 and November 2025 who meet the entry criteria A central dynamic randomisation system was used for 11 allocation to the repositories combined with NSAI treatment group and the physicians choice of chemotherapy sequential repositories combined with NSAI treatment group with stratification factors including level of HR expression and presence of liverlung metastases
This study is planned to include 144 patients with HRHER2-advanced breast cancer with rapidly progressive disease between November 2023 and November 2025 who meet the entry criteria A central dynamic randomisation system was used for 11 allocation to the repositories combined with NSAI treatment group and the physicians choice of chemotherapy sequential repositories combined with NSAI treatment group with stratification factors including level of HR expression and presence of liverlung metastases
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None