Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06340165
Status:
RECRUITING
Last Update Posted:
2024-04-01
First Post:
2024-01-01
Brief Title:
A Real-world Efficacy and Safety Study of Amlotinib for HER2-negative Advanced Breast Cancer
Sponsor:
The First Hospital of Jilin University
Organization:
The First Hospital of Jilin University
Study Overview
Official Title:
A Real-world Study of the Efficacy and Safety of Amlotinib for the Treatment of HER2-negative Advanced Breast Cancer
Status:
RECRUITING
Status Verified Date:
2024-02
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:
This study analyses the efficacy and safety of amlotinib as a study drug in the treatment of HER-2 negative advanced breast cancer in the real world including the number of treatment lines monotherapy combination therapy and different molecular subtypes of breast cancer Evidence-based medicine evidence for clinicians Although the clinical application of amlotinib in breast cancer treatment is a supra-indication drug in view of its high safety and possible good efficacy for advanced breast cancer some patients have been clinically adopted to try the treatment after communicating with their families This study provides evidence for the further use of amlotinib in breast cancer treatment by analysing the efficacy and safety of amlotinib in real-world applications
Detailed Description:
The sample size was calculated according to the One-Sample Log-rank TestDuring the treatment of amlotinib metastatic site imaging was performed every 2-3 cycles and the efficacy assessment and safety information were collected according to the RECIST version 11 criteria After the completion of amlotinib treatment survival follow-up was continued to clarify the survival status of the patients When descriptive statistical analyses of clinicopathological characteristics were performed categorical information was described by frequency counts and constitutive ratios and quantitative information such as conforming to normal distribution was described by mean standard deviation and not conforming to normal distribution was described by median and interquartile spacing Progression-free survival and overall survival at each time point were calculated by the Kaplan-Meier method and plotted as survival curves Log-rank test was used to compare the prognostic differences between groups of latent variables and the prognostic impact of latent variables on the anilotinib-treated patients was analysed using the COX regression risk model for exploratory analysis and the risk ratios hazard ratios HRs for quantitative evaluation Variables with p-values less than 01 in the univariate COX regression analyses were screened by stepwise regression into the multivariate COX regression analyses If the lapse rate exceeded 20 sensitivity analyses were used to assess the impact of the lapse on the endpoint outcome event which was performed by assuming a death outcome for the study subjects who were lost and analysing the endpoint event and then treating the lost patients as normal and analysing the endpoint event and assessing the impact of the lost patients on the endpoint event spss version 210 was used for the statistics and a p005 was considered to be clinically significant
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