A Retrospective Real-world Study of Efficacy, Safety, and Economic Assessment of Abemaciclib Tablets Based on Hospital Information System(HIS) in Hormone Recepter Positive(HR+) Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Progression-free survival(PFS)
研究概览
简要总结
The present study will assess real-world clinical outcomes, adverse events and economics from treatment with endocrine therapy(ET) combined with abemaciclib in patients with hormone receptor-positive(HR+) breast cancer.
详细描述
Based on clinical trials data, Abemaciclib has been approved for early and advanced breast cancer with HR+ and human epidermal growth factor 2 receptor-negative(HER2-), but clinical trials require real-world research data as supplementary validation supporting evidence. This study will assess real-world clinical outcomes, adverse events and economics from treatment with endocrine therapy(ET) combined with abemaciclib in patients with HR+ breast cancer. In addition, this trial will explore the efficacy of Abemaciclib in patients with HR+ and human epidermal growth factor 2 receptor-positive(Her2+) breast cancer.
This study will now include real-world data on efficacy, toxicity and economics of abemaciclib in the adjuvant setting in HR+ breast cancer. Participants to be enrolled will come from an online platform for researches which all the privacy information has been controlled. The investigators are going to gather 2 groups of breast-cancer-one-other-study(BCOOS) 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.
Investigators will measure clinical outcomes, adverse events and economics in each group above.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •Histologically confirmed HR-positive breast cancer and Imaging/pathological evidence of metastasis is available
- •Treatment with abemaciclib in combination with endocrine therapy
- •Any endocrine therapy
- •Having solid tumor efficacy evaluation criteria RECIST 1.1 measurable lesions
排除标准
- •Combined with other primary malignancies
- •Associated with serious non-tumor related diseases, such as cardiovascular system, respiratory system, nervous system, blood system, digestive system
- •Pregnant or lactating women
- •male breast cancer
研究组 & 干预措施
BCOOS-A1
The patients in this array are treated with Abemaciclib and Letrozole/Anastrozole.
干预措施: Abemaciclib and Letrozole/Anastrozole (Drug)
BCOOS-A2
The patients in this array are treated with Letrozole or Anastrozole.
干预措施: Letrozole or Anastrozole (Drug)
BCOOS-B1
The patients in this array are treated with Abemaciclib and Fulvestrant.
干预措施: Abemaciclib and Fulvestrant (Drug)
BCOOS-B2
The patients in this array are treated with Fulvestrant only.
干预措施: Fulvestrant (Drug)
结局指标
主要结局
Progression-free survival(PFS)
时间窗: Through the completion of the study, for an average of 6 months
The time from treatment initiation to either the first documented disease progression or death from any cause.
次要结局
- Objective Remission Rate(ORR)(Up to 36 months)
- Disease Control Rate(DCR)(Up to 36 months)
- Toxicity rate(Up to 36 months)
- Cost-utility analysis(CUA)(Up to 36 months)