ISRCTN18217390已完成3 期
Efficacy and safety of XM22 compared to pegfilgrastim in patients with breast cancer receiving chemotherapy. A multinational, multicentre, randomised, double-blind controlled study
BioGeneriX AG (Germany)0 个研究点目标入组 200 人开始时间: 2010年6月10日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
研究概览
简要总结
2013 results in: https://www.ncbi.nlm.nih.gov/pubmed/23945072
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Provide signed and dated written informed consent
- •2. Men and women aged =18 years
- •3. The patient must be able to understand and follow instructions and must be able to participate in the study for the entire period
- •4. Breast cancer high risk stage II, III or IV according to American Joint Committee on Cancer (AJCC) classification
- •5. Patients planned and eligible to receive 4 cycles of treatment with docetaxel/doxorubicin as routine chemotherapy for their breast cancer disease
- •6. Chemotherapy naïve
- •7. Eastern Cooperative Oncology Group (ECOG) performance status =2
- •8. Absolute Neutrophil Count (ANC) =1.5 x 10*9/L
- •9. Platelet count =100 x 10*9/L
- •10. Adequate cardiac function (including left ventricular ejection fraction =50% as assessed by echocardiography or equivalent method within 4 weeks prior to randomisation)
- •11. Adequate hepatic function, i.e. ALT and AST <2.5 x ULN, alkaline phosphatase <5 x ULN, bilirubin 12. Adequate renal function, i.e. creatinine <1.5 x ULN
排除标准
- •1. Participation in a clinical trial within 30 days before randomisation.
- •2. Previous exposure to filgrastim, pegfilgrastim or lenograstim or other G-CSFs in clinical development less than 6 months before randomisation.
- •3. Known hypersensitivity to docetaxel or doxorubicin, filgrastim, pegfilgrastim or lenograstim.
- •4. Underlying neuropathy of grade 2 or higher.
- •5. Treatment with systemically active antibiotics within 72 hours before chemotherapy.
- •6. Treatment with lithium at inclusion or planned during the entire study.
- •7. Chronic use of oral corticosteroids.
- •8. Prior radiation therapy or tumour surgery within 4 weeks before randomisation.
- •9. Prior bone marrow or stem cell transplantation.
- •10. Prior malignancy within the previous 5 years other than basal cell or squamous cell carcinomas or in situ carcinoma of the cervix.
- •11. Any illness or condition that in the opinion of the investigator may affect the safety of the patient or the evaluation of any study endpoint.
- •12. Pregnant or nursing women. Women of child-bearing potential who do not agree to use a highly effective method of birth control during the entire duration of the study. Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, hormonal IUDs, sexual abstinence or vasectomised partner. Female patients will be considered to be of child-bearing potential unless surgically sterilised by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years (Postmenopausal is defined as the time after which a woman has experienced twelve consecutive months of amenorrhea without a period).
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