Does Adjuvant Zoledronic Acid Reduce Recurrence in Patients With High Risk Localized Breast Cancer?
OBJECTIVES:
Primary
- Compare disease-free survival of women with stage II or III breast cancer at high risk
of relapse treated with neoadjuvant or adjuvant chemotherapy and/or hormonal therapy
with vs without zoledronate.
Secondary
- Compare time to bone metastases, as first recurrence, in patients treated with these
regimens.
- Compare time to bone metastases, per se, in patients treated with these regimens.
- Compare time to distant metastases in patients treated with these regimens.
- Compare overall survival in patients treated with these regimens.
- Compare the reduction in skeletal-related events (fractures, spinal cord compression,
radiotherapy to the bone, surgery to the bone, and hypercalcemia) before and after the
development of bone metastases in patients treated with these regimens.
- Determine the safety and toxicity of zoledronate in patients treated with these
regimens.
- Correlate prognostic factors, such as estrogen-receptor and progesterone-receptor
status, TNM stage, tumor grade, HER2/neu status, and menopausal status with treatment
outcome in patients treated with these regimens.
- Determine more specific prognostic indicators for the development of bone metastases
and factors that are able to predict specific benefit from bisphosphonate treatment
using proteomics, tissue micro-array, and other modern techniques in these patients.
OUTLINE: This is a randomized, open-label, parallel-group, multicenter study. Patients are
stratified according to participating center. Patients are randomized to 1 of 2 treatment
arms.
- Arm I: Patients receive neoadjuvant or adjuvant chemotherapy and/or hormonal therapy.
Patients also receive concurrent zoledronate IV over 15 minutes every 3-4 weeks for 6
doses, every 3 months for 8 doses, and then every 6 months for 5 doses in the absence
of disease progression or unacceptable toxicity.
- Arm II: Patients receive neoadjuvant or adjuvant chemotherapy and/or hormonal therapy
alone.
After completion of study treatment, patients are followed annually for 5 years.
PROJECTED ACCRUAL: A total of 3,300 patients (1,650 per treatment arm) will be accrued for
this study within 3 years.
Interventional
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Disease-free survival as assessed annually for 10 years
No
Robert E. Coleman, MD, FRCP
Cancer Research Centre at Weston Park Hospital
United States: Federal Government
CDR0000335111
NCT00072020
August 2003
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