Ignite Creation Date:
2024-05-06 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 2:20 PM
Study NCT ID:
NCT05167643
Status:
UNKNOWN
Last Update Posted:
2022-04-07
First Post:
2021-11-03
Brief Title:
H Trastuzumab or Biosimilar Combined With CDK46 Inhibitor AIOFS in the Treatment of HRHER2 Advanced Breast Cancer Efficacy and Safety a Chinese Multi-center Real World Study
Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Organization:
Tianjin Medical University Cancer Institute and Hospital
Study Overview
Official Title:
Exploratory Study of HR-positive HER2-positive MBC Combined Treatment Plan
Status:
UNKNOWN
Status Verified Date:
2021-10
Last Known Status:
RECRUITING
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 study is a multi-center prospective real-world clinical study mainly evaluating the efficacy and safety of H combined with CDK46 inhibitor AI in the treatment of HRHER2 advanced breast cancer exploring potential biomarkers
Detailed Description:
This study is a multi-center prospective Because of the non-interventional nature of this study the choice of H can be trastuzumab biosimilar drugs Hantriyou enituzumab etc The CDK46 inhibitor can be piperazil abecilil and the like AI can be letrozole anastrozole exemestane This study does not change or interfere with clinicians diagnosis and treatment decisions as well as patients actual medical practicesThis real-world study will not do formal inference statistical analysis All hypothesis testing is exploratory A comprehensive statistical analysis plan SAP will be prepared and finalized before the data is locked and analyzed Descriptive statistics will be performed including the number and percentage of categorical variables as well as the number average standard deviation median maximum and minimum of continuous variables Kaplan-Meier survival analysis was used to calculate the median PFS and OS and their 95 confidence intervals The median time to disease progression and median survival time will also be calculated as well as its 95 confidence interval ORR and CBR will be analyzed and expressed by the ratio and the corresponding 95 confidence interval CI The multivariate logistic regression model was used to calculate the odds ratio OR and its 95 confidence interval and p-value The subgroup analysis of PFS and OS was analyzed by Log-rank test The COX proportional hazard regression model is used to calculate the hazard ratio and its 95 confidence interval
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?:
None
Is an FDA AA801 Violation?:
None