A rEtrospectIve Real-world Analysis of earLy responsE ratEs With Ribociclib and Endocrine Therapy and Descriptive aNalysis of HR+, HER2- Metastatic Breast Cancer Patients Treated With Chemotherapy (EILEEN)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 194
- 试验地点
- 1
- 主要终点
- Overall Response Rate (ORR) at First Assessment After Initiation of Treatment Combinations
研究概览
简要总结
EILEEN was a non-interventional/observational, retrospective, multi-center, real life cohort study conducted in 14 private and academic oncology clinics in Turkey. Group I cohort of the study was based on secondary use of data of postmenopausal hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (MBC) patients treated with ribociclib in combination with letrozole (LET) or fulvestrant (FUL) after June 2020. Group II cohort of the study was a parallel, comprehensive chart review for detecting all postmenopausal HR+, HER2- MBC patients who were eligible for cyclin-dependent kinase inhibitors (CDKis) but received chemotherapy. The study used secondary data which was retrieved from electronic or paper medical records or clinical databases available at the sites. Regular follow up with close monitorization was used for the effective management of patients with breast cancer. Data sources included information about diagnosis, treatment and monitorization of patients at an individual level. The study used medical patient records at hospitals e.g. hospital discharge files, primary clinical records and electronic medical records.
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
- •Group I: Postmenopausal female patients who had histologically or cytologically confirmed HR-positive (10% or more ER+), HER2-negative, metastatic breast cancer and initiated ribociclib combinations per local label.
- •Treated with ribociclib plus letrozole relapsed after 12 months completing adjuvant treatment or without any prior endocrine treatment for metastatic disease, 1 line or less chemotherapy was allowed.
- •Treated with ribociclib plus fulvestrant, clinical and/or radiological disease progression after at least 6 months and at least 1 aromatase inhibitor treatment for metastatic disease or relapsed after 12 months adjuvant aromatase inhibitor treatment and/or relapsed within 12 months completing adjuvant aromatase inhibitor, 2 lines or less prior treatments and 1 line or less prior chemotherapy at metastatic setting were allowed.
- •Had first treatment response rate assessment within 6 months after ribociclib initiation.
- •Initiated ribociclib in combination with letrozole/fulvestrant after MBC diagnosis after local approval of ribociclib in June
- •Group II: Postmenopausal female patients who had histologically or cytologically confirmed HR-positive (10% or more ER+), HER2-negative, metastatic breast cancer eligible for cyclin-dependent kinase (CDK) inhibitors according to local label but started chemotherapy.
排除标准
- •Pre- or perimenopausal women.
- •Enrollment in an interventional clinical trial for MBC during the study observation period.
- •Evidence of prior treatment with any CDK4/6 inhibitor in the adjuvant setting.
- •Evidence of another primary cancer within 3 years prior to the initial line containing ribociclib.
结局指标
主要结局
Overall Response Rate (ORR) at First Assessment After Initiation of Treatment Combinations
时间窗: Up to 6 months
Treatment combinations included ribociclib plus letrozole and ribociclib plus fulvestrant. ORR was defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR) according to RECIST v1.1.
次要结局
- Number of Patients Categorized by Former Treatment(Baseline)
- Number of Patients who Used Chemotherapy per Treatment Combination(Up to 3 years)
- Progression Free Survival (PFS)(Up to 3 years)
- Overall Survival (OS)(Up to 3 years)
- Time to Progression(Up to 3 years)
- Time to Chemotherapy Post-ribociclib Plus Letrozole or Fulvestrant Treatments(Up to 3 years)
- Duration of Treatment(Up to 3 years)
- Proportion of Patients With Complete Response (CR)/Partial Response (PR)/Stable Disease (SD)/Progressive Disease (PD)(Up to 6 months)
- Clinical Benefit Rate (CBR)(Up to 6 months)