Efficacy and Safety of XM22 compared to pegfilgrastim in patients with breast cancer receiving chemotherapy. A multinational, multicentre, randomised, double-blind controlled study

BioGeneriX AG0 个研究点目标入组 250 人开始时间: 2010年2月12日最近更新: 2012年3月19日

试验速览

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•Written informed consent.
•Men and women aged =18 years.
•The patient must be able to understand and follow instructions and must be able to participate in the study for the entire period.
•Breast cancer high risk stage II, III or IV according to American Joint Committee on Cancer (AJCC) classification
•Patients planned and eligible to receive 4 cycles of treatment with docetaxel/doxorubicin as routine chemotherapy for their breast cancer disease.
•Chemotherapy naive.
•Eastern Cooperative Oncology Group (ECOG) performance status =2.
•ANC =1.5 x 10(9)/L.
•Platelet count =100 x 10(9)/L.
•Adequate cardiac function (including left ventricular ejection fraction =50% as assessed by echocardiography or equivalent method within 4 weeks prior to randomisation).
•Adequate hepatic function, i.e. alanine and aspartate aminotransferases (ALT and AST) <2.5 x upper limit of normal (ULN), alkaline phosphatase <5 x ULN, bilirubin • Adequate renal function, i.e. creatinine <1.5 x ULN.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Participation in a clinical trial within 30 days before randomisation.
•Previous exposure to filgrastim, pegfilgrastim or lenograstim or other G-CSFs in clinical development less than 6 months before randomisation.
•Known hypersensitivity to docetaxel or doxorubicin, filgrastim, pegfilgrastim or
•lenograstim.
•Underlying neuropathy of grade 2 or higher.
•Treatment with systemically active antibiotics within 72 hours before chemotherapy.
•Treatment with lithium at inclusion or planned during the entire study.
•Chronic use of oral corticosteroids.
•Prior radiation therapy or tumour surgery within 4 weeks before randomisation.
•Prior bone marrow or stem cell transplantation.
•Prior malignancy within the previous 5 years other than basal cell or squamous cell carcinomas or in situ carcinoma of the cervix.
•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.
•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

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