Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06340165 |
| Other study ID # |
2023-KS-151 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 4, 2024 |
| Est. completion date |
June 2025 |
Study information
| Verified date |
February 2024 |
| Source |
The First Hospital of Jilin University |
| Contact |
Jiuwei Cui |
| Phone |
15843073215 |
| Email |
jdyycjw[@]163.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
The sample size was calculated according to the One-Sample Log-rank Test.During 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 1.1
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 0.1 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 21.0 was used for the statistics, and a p<0.05 was considered to be clinically
significant.
