Observational study of frequency and causes of impaired liver metabolism of cyclophosphamide in breast cancer

niversity of Auckland0 个研究点目标入组 50 人开始时间: 2012年11月6日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•ECOG (Eastern Cooperative Oncology Group) Performance Status 0-2
•Histologically confirmed breast cancer
•To receive intravenous cyclophosphamide as part of adjuvant, neoadjuvant or first line chemotherapy for breast cancer as part of standard care.
•Staging investigations in process (should not be greater than 2 weeks after start of chemotherapy).
•Patients must be able to provide written informed consent
•Aspartate transaminase (AST), Alaninine transaminase (ALT) =< 2.5 X upper limit of normal (ULN) for institution
•Alkaline phosphatase <5x ULN
•Bilirubin =< ULN, except when due to Gilbert’s Disease
•Creatinine <1.5

•Patients receiving medication which is either a CYP2C19 inhibitor or inducer, and where a washout period of 5 days is not clinically feasible
•Chronic inflammatory condition such as systemic lupus erythematosis, inflammatory bowel disease, other autoimmune phenomenon or active chronic infection
•Active infections (e.g. wound) at time of chemotherapy
•Pregnant or breast feeding
•Other active malignancy within the last 5 years, excluding non-melanoma skin cancers, or preinvasive cervical cancer that has been treated definitively

发起方

niversity of Auckland