A Pharmacogenomics Study for Breast Cancer Patients Undergoing Adjuvant Chemotherapy With Doxorubicin (A)/Cyclophosphamide ©) and/or Weekly Paclitaxel
- Determine the pharmacogenomics of adjuvant chemotherapy comprising doxorubicin and
cyclophosphamide and/or paclitaxel in women with nonmetastatic invasive breast cancer.
- Determine treatment-induced myelosuppression (e.g., neutropenia) in patients treated
with adjuvant doxorubicin and cyclophosphamide who have polymorphisms in drug
activation and metabolism genes.
- Correlate the incidence of peripheral neuropathy with pharmacogenomic analysis in
patients treated with paclitaxel.
- Determine response (i.e., relapse in the adjuvant setting) during a 10-year follow-up
period in patients treated with these regimens.
OUTLINE: This is a multicenter study. Patients receive treatment on CALGB-40101 OR are
assigned to receive 1 of 2 treatment regimens on this study.
- Regimen 1: Patients receive doxorubicin IV over 10 minutes and cyclophosphamide IV over
30 minutes on day 1. Treatment repeats every 21 days for 4 courses.
- Regimen 2: Patients receive doxorubicin and cyclophosphamide as in regimen 1. Patients
then receive paclitaxel IV over 1 hour once weekly for 12 weeks.
After completion of study treatment, patients are followed at 3, 6, and 12 months and then
annually for up to 10 years.
PROJECTED ACCRUAL: A total of 500 patients (300 treated with doxorubicin and
cyclophosphamide and 200 treated with paclitaxel) will be accrued for this study within 3-4
Masking: Open Label, Primary Purpose: Treatment
Pharmacogenomics of doxorubicin, cyclophosphamide, and paclitaxel
Paul K. Marcom, MD
Duke Cancer Institute
|Duke Cancer Institute||Durham, North Carolina 27710|