Efficacy and Safety of XM 02 compared to Filgrastim in patients with breast cancer receiving chemotherapy. Multinational, multicentre, randomised, controlled study

BioGeneriX0 个研究点目标入组 280 人开始时间: 2004年10月28日最近更新: 2012年3月19日

试验速览

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•Female and male patients of any ethnic origin with a diagnosis of breast cancer meeting all criteria listed below, will be included in the study.
•- Signed and dated written informed consent
•- Age 18 years and above
•- Breast cancer high risk stage II, or stage III or IV (classification according to American Joint Committee on Cancer [AJCC] see appendix to the protocol)
•- Patients planned/eligible to receive treatment with docetaxel/doxorubicin as routine chemotherapy for their breast cancer disease
•- Chemotherapy naïve or have received no more than one previous regimen of chemotherapy
•- Completion of previous chemotherapy more than 4 weeks before randomisation
•- Eastern Cooperative Oncology Group (ECOG) performance status £2
•- Platelet count equal/more then 100 x 109/L
•- Adequate cardiac function (including left ventricular ejection fraction equal/more then 50% as assessed by echocardiography)
•- Adequate hepatic function i.e., alanine and aspartate aminotransferases (ALT/AST) <2.5 x upper normal limit (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

•Patients presenting with any of the following will not be included in the study:
•- Participation in a clinical trial within 30 days before randomisation
•- Previous exposure to Filgrastim, Pegfilgrastim or Lenograstim
•- Known hypersensitivity to Docetaxel
•- Underlying neuropathy of grade 2 or higher
•- Treatment with systemically active antibiotics within 72 hours before chemotherapy
•- Treatment with lithium
•- Chronic use of oral corticosteroids
•- Prior radiation therapy within 4 weeks before randomisation
•- Prior bone marrow or stem cell transplantation
•- Prior total lifetime exposure to doxorubicin >240 mg/m² or epirubicin >600 mg/m²
•- 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 are excluded. Women of child-bearing potential must agree to use a chemical or barrier contraceptive during the treatment period

发起方

BioGeneriX