An observational cohort study of toxicity in female patients treated for early breast cancer with Adriamycin and Cyclophosphamide chemotherapy.
- Conditions
- Early Breast Cancer.Cancer - Breast
- Registration Number
- ACTRN12607000464460
- Lead Sponsor
- Dr Anne O'Donnell
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 165
Age = 18 years.
Female patients receiving Adriamycin (60mg/m2) and Cyclophosphamide (600mg/m2) chemotherapy for early breast cancer in the study institution(s).
Adequate pre-treatment bone marrow function defined as absolute neutrophil count = 1.5×106/L , platelet count = 100×109/L.
Calculated creatinine clearance by Cockroft-Gault or MDRD (Modification of Diet in Renal Disease) equation of = 60ml/min.
Ability to understand and the willingness to sign a written informed consent document.
Previous exposure to cytotoxic agents or long-term immunosuppression.
Patient not willing to have chemotherapy at the study centre(s).
Known hypersensitivity to Adriamycin or Cyclophosphamide.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of Treatment Modifying Toxicity.[Over four cycles of chemotherapy - any modification to treatment due to toxicity will be recorded at each treatment visit.]
- Secondary Outcome Measures
Name Time Method adir neutrophil count.[Post cycle one at Day 10.];Rate of grade 3 toxicities.[Over four cycles of chemotherapy - at each treatment visit.]