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Clinical Trial Summary

The present study will assess real-world clinical outcomes, adverse events and economics from treatment with endocrine therapy combined with abemaciclib in patients with HR-positive breast cancer.


Clinical Trial Description

Based on clinical trials data, Abemaciclib has been approved for early and advanced breast cancer with hormone receptor-positive and human epidermal growth factor 2 receptor-negative, but clinical trials require real-world research data as supplementary validation supporting evidence. Our study will assess real-world clinical outcomes, adverse events and economics from treatment with endocrine therapy combined with abemaciclib in patients with HR-positive breast cancer. In addition, this trial will explore the efficacy of Abemaciclib in patients with hormone receptor-positive and human epidermal growth factor 2 receptor-positive breast cancer. Our study will now include real-world data on efficacy, toxicity and economics of abemaciclib in the adjuvant setting in HR-positive breast cancer. Patients to be enrolled will come from an online platform for researches which all the privacy information has been controlled. We are going to gather 2 groups including BCOOS-A and BCOOS-B. Group BCOOS-A includes the patients treated with Abemaciclib and Letrozole/Anastrozole compared with treated with Letrozole/Anastrozole only. Group BCOOS-B includes the patients treated with Abemaciclib and Fulvestrant compared with treated with Fulvestrant only. We'll measure clinical outcomes, adverse events and economics in each group above. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06341283
Study type Observational
Source The Affiliated Hospital of Qingdao University
Contact Yu Cao, docter
Phone +8653282911261
Email caoyu@qdu.edu.cn
Status Not yet recruiting
Phase
Start date June 1, 2024
Completion date July 1, 2025

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