NCT02761642已完成2 期
Multicenter Study for the Evaluation of Efficacy and Safety of NeoRecormon® Therapy Administered as 30000 IU Subcutaneously in Anemic Patients With Breast Cancer Treated With Chemotherapy
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 200
- 主要终点
- Percentage of Participants With Response to Treatment Based on Hemoglobin Levels
研究概览
简要总结
This study will evaluate the efficacy and safety of subcutaneous (SC) epoetin beta in anemic participants with breast cancer undergoing chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Adult female participants with histological diagnosis of breast cancer
- •Any type of chemotherapy planned for greater than or equal to (>/=) 9 weeks
- •Hemoglobin level less than (<) 11 grams per deciliter (g/dL)
- •Participants able to receive iron supplement, if necessary
排除标准
- •Known or suspected contraindications to epoetin beta
- •Pregnancy or lactation period
- •Diagnosis of anemia only due to iron-deficiency
- •Diagnosis of thalasemic syndromes
- •Epilepsy and/or cerebral metastasis
- •Blood transfusion or treatment with any erythropoietic factor within 4 weeks before study start
研究组 & 干预措施
Epoetin Beta
Experimental
Anemic breast cancer participants will receive epoetin beta treatment for 12 weeks.
干预措施: Epoetin Beta (Drug)
结局指标
主要结局
Percentage of Participants With Response to Treatment Based on Hemoglobin Levels
时间窗: Week 12
Response was defined as increase of hemoglobin levels by at least 2 grams per deciliter (g/dL) as compared to baseline or the achievement of hemoglobin level of 12 g/dL after 12 weeks of treatment in the absence of red blood cells transfusion.
次要结局
- Quality of Life Assessment Using Functional Assessment of Cancer Therapy-Anemia (FACT-An) Questionnaire Scores(Baseline, Week 12)
- Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment in Participants According to the Hemoglobin Level at Baseline(Baseline, Week 12)
- Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment in Participants According to Chemotherapy at Baseline(Baseline, Week 12)
- Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment in Participants According to the Time Spent on Chemotherapy at Baseline(Baseline, Week 12)
- Overall Mean Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment(Baseline, Week 12)
- Percentage of Participants With an Increase From Baseline in Hemoglobin Levels of At Least 1 g/dL After 4 Weeks(Baseline, Week 4)
- Mean Time Needed to Increase Hemoglobin Level by At Least 1 g/dL(Baseline up to Week 12)
研究者
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