Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06656624
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-23
Brief Title:
Efficacy and Safety of Ribociclib Combined With AI Versus PhysicianAmp39s Choice of Chemotherapy Sequential Endocrine Therapy in ER Middle-low-expressionHER2-negative Advanced Breast Cancer Rachel
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy and Safety of Ribociclib Combined With AI Versus PhysicianAmp39s Choice of Chemotherapy Sequential Endocrine Therapy in ER Medium to Low ExpressionHER2-negative Advanced Breast Cancer a Phase II Randomised Controlled Clinical Study
Status:
RECRUITING
Status Verified Date:
2024-10
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:
To compare the efficacy and safety of ribociclib in combination with aromatase inhibitor and physicians choice of chemotherapy sequential endocrine therapy in the first-line treatment of ER medium to low expressionHER2-negative advanced breast cancer
Detailed Description:
The main goal of this clinical trial is to compare in the efficacy of Ribociclib in combination with AI versus physicians choice of chemotherapy sequential endocrine therapy in ER medium to low expressionHER2-negative 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 ER medium to low expressionHER2- negative advanced breast cancer
This study is planned to include 190 patients with ER medium to low expressionHER2- negative advanced breast cancer between August 2024 and December 2025 who meet the entry criteria In this study it is proposed to randomise the enrolled patients using stratified grouping block randomisation method The enrolled patients were firstly stratified based on 1 presence of visceral metastases and 2 disease-free interval or 2 years assessment
This study is planned to include 190 patients with ER medium to low expressionHER2- negative advanced breast cancer between August 2024 and December 2025 who meet the entry criteria In this study it is proposed to randomise the enrolled patients using stratified grouping block randomisation method The enrolled patients were firstly stratified based on 1 presence of visceral metastases and 2 disease-free interval or 2 years assessment
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