A Phase III Randomized Trial With Neo-Adjuvant Chemotherapy (TAC) With or Without Zoledronic Acid for Patients With HER2-Negative Large Resectable or Locally Advanced Breast Cancer (NEO-ZOTAC)
- 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.
- To correlate clinical response with pathological responses in both treatment arms.
- To evaluate the disease-free survival and overall survival of patients treated with
- To evaluate the safety and tolerability of adding zoledronic acid to neoadjuvant
- To evaluate heterogeneity of the ER/PR and HER2 measurement in core biopsy and the
OUTLINE: Patients are randomized to 1 of 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.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Pathologic complete response after neoadjuvant chemotherapy with or without zoledronic
Judith Kroep, MD
Leiden University Medical Center