OBJECTIVES:
Primary
* To determine the value of neoadjuvant chemotherapy comprising doxorubicin hydrochloride, cyclophosphamide, and docetaxel with or without zoledronic acid in patients with HER2-negative large resectable or locally advanced breast cancer.
Secondary
* To correlate clinical response with pathological responses in both treatment arms.
* To evaluate the disease-free survival and overall survival of patients treated with this regimen.
* To evaluate the safety and tolerability of adding zoledronic acid to neoadjuvant chemotherapy.
* To evaluate heterogeneity of the ER/PR and HER2 measurement in core biopsy and the surgical specimen.
OUTLINE: Patients are randomized between 2 treatment arms.
* Arm I: Patients receive doxorubicin hydrochloride IV, cyclophosphamide IV, and docetaxel IV on day 1. Patients also receive zoledronic acid IV over 15 minutes on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients receive doxorubicin hydrochloride IV, cyclophosphamide IV, and docetaxel IV as in arm I. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.