Trial Information

Adjuvant Therapy of Breast Cancer: Impact of Erythropoiesis Stimulating Factors on Event Free Survival High Risk Breast Cancer Treatment

OBJECTIVES:

Primary

- Compare the disease-free survival rate in women with stage III breast cancer treated
with adjuvant chemotherapy with vs without darbepoetin alfa.

Secondary

- Compare local recurrence and overall survival in patients receiving these regimens.

- Compare toxicity of these regimens in these patients.

- Compare quality of life and fatigue frequency in patients treated with these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according the chemotherapy regimen (CEF vs TAC). Patients are randomized to 1 of 2 treatment
arms.

- Arm I: Patients receive 1 of the following regimens:

- Regimen CEF: Patients receive cyclophosphamide IV, epirubicin hydrochloride IV,
and fluorouracil IV on day 1.

- Regimen TAC: Patients receive docetaxel IV, doxorubicin hydrochloride IV, and
cyclophosphamide IV on day 1.

Treatment repeats every 3 weeks for 6 courses in the absence of disease progression and
unacceptable toxicity.

- Arm II: Patients receive 1 of the following regimens:

- Regimen CEF: Patients receive regimen CEF as in arm I. Patients receive
darbepoetin alfa if hemoglobin falls to ≤ 13.0 g/dL. Darbepoetin alfa is
discontinued when hemoglobin rises to > 14.0 g/dL.

- Regimen TAC: Patients receive TAC as in arm I and darbepoetin alfa as in arm II,
regimen CEF.

Quality of life is assessed at baseline, before each chemotherapy course, at the completion
of study therapy, and at 6 and 12 months.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 1,234 patients will be accrued for this study.