Early breast cancer
Conditions
Interventions
Product Name: Doxorubicin
Pharmaceutical Form: Intravenous infusion
Product Name: Cyclophosphamide
Pharmaceutical Form: Intravenous infusion
Trade Name: Fluorouracil
Pharmaceutical Form: Solution fo
Sponsors
Newcastle upon Tyne Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a) Aged 18 years or over. b) Histological confirmation of primary breast cancer. c) Written voluntary informed consent. d) ECOG performance status of 0, 1, or 2[15] (see appendix 12.1). e) Patients must have recovered from any major surgery effects, with a minimum of 2 weeks from time of surgery to drug administration. f) Estimated life expectancy should be greater than 3 months. g) Patients should have adequate haematological & biochemical parameters recorded within 2 weeks leading up to an anthracycline containing regimen administration, specifically: Absolute neutrophil count > 1.0 x 109/L Platelet count > 100 x 109/L Haemoglobin > 9g/dL Bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: a) Pregnancy or breastfeeding. b) Patients with a history of another malignancy in the past 5 years with the exception of surgically cured basal cell cancer of the skin, cervical carcinoma in situ, or ductal (breast) carcinoma in situ. c) Patients who have received prior radiotherapy or cytotoxic chemotherapy for any indication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the relationship between allelic variations in genes which influence doxorubicin, epirubicin, cyclophosphamide and fluorouracil transport and metabolism and the pharmacokinetics of these drugs used in the treatment of breast cancer.;Secondary Objective: 1) To correlate pharmacokinetics with toxicity (White Blood Cell nadir count) 2) To correlate allelic mutations with chemotherapy toxicity and its delivered dose intensity ;Primary end point(s): Concentrations of doxorubicin, epirubicin, cyclophosphamide, fluorouracil and their metabolites will be measured in the blood samples withdrawn at the appropriate times relative to the chemotherapy infusion in our study population. Measurements will be made by LCMS (Liquid Chromatography-Mass Spectrometry) for cyclophosphamide and HPLC (High Performance Liquid Chromatography) with fluorescence detection for doxorubicin and doxorubicinol, epirubicin, epirubicinol and fluorouracil. Patients will be genotyped for known polymorphisms in genes potentially involved in genes which influence doxorubicin, epirubicin, cyclophosphamide and fluorouracil transport and metabolism of the above drugs using DNA obtained from a single 10ml blood sample. | — |
Countries
United Kingdom
Outcome results
None listed