NCT05167643

H (Trastuzumab or Biosimilar) Combined With CDK4/6 Inhibitor + AI±OFS in the Treatment of HR+HER2+ Advanced Breast Cancer Efficacy and Safety: a Chinese Multi-center Real World Study

Exploratory Study of HR-positive HER2-positive MBC Combined Treatment Plan

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a multi-center prospective real-world clinical study, mainly evaluating the efficacy and safety of H combined with CDK4/6 inhibitor + AI in the treatment of HR+/HER2+ 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 CDK4/6 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 practices.This 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.

Conditions

• Advanced HR+ HER2 Negative Breast Carcinoma

Interventions

Type	Name	Description
DRUG	Enituzumab injection+Abesili tablets+Anastrozole tablets	According to the current clinical guidelines combined with clinical practice, the treating physicians recommended the treatment plan to the subjects, and decided to enroll HR+/HER2+ advanced breast cancer patients treated with H combined with CDK4/6 inhibitor + AI±OFS into this study

Timeline

• Start date: 2022-01-23
• Primary completion: 2022-10-23
• Completion: 2024-08-23
• First posted: 2021-12-22
• Last updated: 2022-04-07

Locations

1 site across 1 country: China