Dose-finding of a fixed dose XM22 in patients with breast cancer receiving 4 cycles of chemotherapy versus 6 mg Neulasta®

BioGeneriX AG0 个研究点目标入组 200 人开始时间: 2008年1月4日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•Female and male patients of any ethnic origin with a diagnosis of breast cancer meeting all criteria listed below can be included in the study.
•Signed and dated written informed consent.
•Men and women aged = 18 years.
•Breast cancer high risk stage II, or stage III or IV (classification according to American Joint Committee on Cancer [AJCC]).
•Patients planned/eligible to receive treatment with docetaxel/doxorubicin as routine CTX for their breast cancer disease.
•CTX-naïve.
•Eastern Cooperative Oncology Group (ECOG) performance status = 2.
•ANC = 1.5 x 10E9/L.
•Platelet count = 100 x 10E9/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., ALT/AST < 2.5 x upper limit of normal (ULN), alkaline phosphatase < 5 x ULN, bilirubin < ULN.
•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, lenograstim, or other G-CSFs in clinical development.
•Known hypersensitivity to docetaxel.
•Underlying neuropathy of grade 2 or higher.
•Treatment with systemically active antibiotics within 72 hours before CTX.
•Treatment with lithium.
•Chronic use of oral corticosteroids.
•Prior radiation therapy 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. 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 childbearing potential unless surgically sterilised by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years.

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