Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer
- Compare disease-free survival and overall survival of women with resected primary stage
I-III adenocarcinoma of the breast treated with adjuvant zoledronate vs clodronate vs
- Compare the distributions of sites of first disease recurrence in patients treated with
- Compare adverse events in patients treated with these drugs.
- Correlate parathyroid hormone related protein status and N-telopeptide levels at
baseline with disease-free survival and sites of first recurrence in patients treated
with these drugs.
- Investigate whether there is an association between inherited germ-line single
nucleotide polymorphisms (SNP, rs2297480) in farnesyl diphosphate synthase (FDPS) and
the adverse event of acute phase reactions in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 3
- Arm I: Patients receive zoledronate IV over 15 minutes once a month for 6 months and
then once every 3 months for 2.5 years.
- Arm II: Patients receive oral clodronate once daily for 35 months.
- Arm III: Patients receive oral ibandronate once daily for 35 months. Treatment in all
arms continues in the absence of disease recurrence or unacceptable toxicity.
After completion of study treatment, patients are followed every 6 months until disease
recurrence and then annually for up to 10 years.
PROJECTED ACCRUAL: A total of 5,400 will be accrued for this study.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Histologic confirmation of disease recurrence
scans or biopsy at recurrence
Julie R. Gralow, MD
Seattle Cancer Care Alliance
United States: Federal Government