Observational pharmacokinetic study of doxorubicin and cyclophosphamide in patients with early breast cancer. - AC PK Study

• Conditions: Early breast cancer

• Registration Number: EUCTR2005-004126-56-GB
• Lead Sponsor: ewcastle upon Tyne Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02-06
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 50

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 < 1.5 x upper limit of normal (ULN)
AST/ALT < 2.5 x ULN
Alkaline phosphatase < 2.5 x ULN
Creatinine < 1.5 x ULN.
h)Women of childbearing potential should be practicing medically approved contraceptive precautions, in line with standard practice. There is no specific requirement for pregnancy testing.

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified