Observational study of frequency and causes of impaired liver metabolism of cyclophosphamide in breast cancer
- Conditions
- Breast CancerCancer - Breast
- Registration Number
- ACTRN12612001170819
- Lead Sponsor
- niversity of Auckland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 50
Age>18
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method