A Randomized, Open-label, Multicenter, Phase 3 Study of Epoetin Alfa Plus Standard Supportive Care Versus Standard Supportive Care in Anemic Patients With Metastatic Breast Cancer Receiving Standard Chemotherapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,098
- 主要终点
- Progression Free Survival
研究概览
简要总结
The purpose of this study is to assess the impact on tumor progression as evaluated by progression-free survival (PFS) of epoetin alfa plus standard supportive care as compared with standard supportive care alone (packed red blood cell (RBC) transfusions), for treating anemia according to label guidance in patients with metastatic breast cancer receiving standard chemotherapy.
详细描述
Anemia is a common complication of the treatment of metastatic breast cancer and is related to the effects of chemotherapy and to chronic disease itself. This is a randomized, open-label, multicenter, international study to further examine the safety of the study drug used with standard supportive care (i.e., packed RBC transfusions) compared to standard supportive care alone, when used to treat anemia associated with chemotherapy. This study will be done in subjects with metastatic breast cancer who are being or will be treated with first-line chemotherapy with standard dose schedules of taxane monotherapy, or a taxane plus trastuzumab, or an anthracycline plus either a taxane or cyclophosphamide. The study hypothesis is that epoetin alfa, when used as supportive anemia care, does not increase the risk of tumor progression or death. The study treatment will be compared to the control treatment by comparing progression-free survival, i.e., the number of months from the date a patient is randomized into the trial to the date of the first documented disease progression or death. In addition to their chemotherapy, half of the subjects will be assigned to receive study drug (epoetin alfa) and half of the subjects will be assigned to standard supportive care for anemia. Subjects treated with the study drug will receive standard supportive care (packed RBC transfusions) plus 40,000 IU epoetin alfa given subcutaneously once a week until 4 weeks after the last cycle of chemotherapy or until disease progression, whichever comes first.The hypothesis is to test that epoetin alfa, when used as supportive anemia care, is non-inferior to control (standard supportive care alone), as measured by progression free survival (PFS). Patients treated with the study drug will receive standard supportive care (packed red blood cells (RBC) transfusions) plus 40,000 IU epoetin alfa given subcutaneously once a week until 4 weeks after the last cycle of chemotherapy or until disease progression, whichever comes first. Dose adjustments (dose escalation, dose reduction, dose interruption, and dose resumption) of epoetin alfa will be based on hemoglobin (Hb) and confirm to prescribing information.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed (e.g., slide of tissue) breast cancer
- •HER2/NEU positive or negative
- •Clinical evidence of metastasis (e.g., biopsy) with at least 1 measurable metastatic (M1) lesion prior to starting the current chemotherapy
- •Received 1st and 2nd line chemotherapy
- •Hemoglobin (Hb) <= 11g/dL at the time of randomization
- •planned to receive at least 2 more cycles of chemotherapy
- •Life expectancy > 6 months
- •Eastern Cooperative Oncology Group score 0 or 1
- •At least 18 years old using effective birth control or surgically sterile or postmenopausal for 1 year
排除标准
- •Active second cancer
- •no recent history of clinically relevant thrombovascular event
- •Current treatment with anticoagulants
- •Brain metastasis or CNS involvement
- •Anemia secondary to another cause
- •Recent (within prior 1 months) use of an ESA
- •Patient pregnant or breast feeding
- •Progressive disease during adjuvant/neoadjuvant chemotherapy
- •Rapidly progressive or life-threatening metastatic disease
- •Concomitant endocrine therapy
- •Patient in whom the only site of metastasis was local and was successfully treated surgically.
研究组 & 干预措施
001
epoetin alfa + packed RBC transfusion 40 000 IU SC once a week.
干预措施: epoetin alfa + packed RBC transfusion (Drug)
002
Standard supportive care (packed RBC transfusion) Per doctor prescription
干预措施: Standard supportive care (packed RBC transfusion) (Other)
结局指标
主要结局
Progression Free Survival
时间窗: From the date of randomization to the date of disease progression (PD) or death, whichever occurred first (up to 8.4 years)
Progression free survival was based in investigator-determined progressive disease (PD) and calculated from the date of randomization to the date of PD or the date of death, whichever occurred first. Participants who had not progressed and were still alive at the time of clinical cut off were censored at the last disease assessment prior to the clinical cutoff. For PD or death with a missing interval immediately preceding the event, progression-free survival (PFS) was censored at the last disease assessment prior to the missing interval. Participants who withdrew from the study (withdrawal of consent or lost to follow-up) without progression were censored at the time of the last disease assessment.
次要结局
- Overall Survival(From randomization up to death from any cause (up to 8.4 years))
- Time to Tumor Progression(From date of randomization to the date of the first documented PD (up to 8.4 years))
- Overall Response Rate (ORR)(every 8 weeks for 1 year and then every 12 weeks until PD or death, whichever occurred first (up to 8.4 years))
- Percentage of Participants With Suspected Thrombotic Vascular Events (TVEs)(up to 8.4 years)