RATIONALE: Zoledronate, clodronate, or ibandronate may delay or prevent bone metastases in patients with nonmetastatic breast cancer. It is not yet known whether zoledronate is more effective than clodronate or ibandronate in treating breast cancer. PURPOSE: This randomized phase III trial is studying zoledronate to see how well it works compared to clodronate or ibandronate in treating women who have undergone surgery for stage I, stage II, or stage III breast cancer.
Name: clodronate disodium
Name: ibandronate sodium
Name: zoledronic acid
Description: Time from date of registration to date of first observation of recurrence or death due to any cause. Patients last known to be alive who have not experienced recurrence of disease are censored at their last contact date. The outcome for the disease-free survival will be presented as 5 year survival rate.Measure: Disease-free Survival Time: Disease assessments are completed every 6 months for 5 years then annually for 5 years or until death or recurrence
Description: Time from date of registration to date of death due to any cause. Patients last known to be alive are censored at their last contact date. The outcome for overall survival will be presented as 5 year overall survival rate.Measure: Overall Survival Time: follow up completed every 6 months for 5 years and then annually for 5 years or until death
Description: All sites of invasive disease documented within 30 days of first documentation of invasive recurrence.Measure: Distributions of Sites of First Recurrence on the Three Arms. Time: Disease assessments are completed every 6 months for 5 years then annually for 5 years or until death or recurrence
Description: Adverse Events (AEs) are reported by CTCAE Version 4.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.Measure: Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Time: Toxicity assessment is repeated every 2 months for the first 6 months, then every 3 months until 3 years or end of treatment.
There is one SNP
- 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.