This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This phase III prospective randomized, double-blind, placebo-controlled trial in women with early-stage breast cancer that will evaluate the worth of clodronate, a second-generation bisphosphonate. Bisphosphonates have been shown to block the breakdown of bones, and in one small open label study, had a beneficial effect on bone metastases in patients with breast cancer. This study's primary aim is to determine whether 1600 mg/day of clodronate administered for 3 years, whether alone or in addition to adjuvant chemotherapy and/or hormonal therapy will improve disease-free survival. This study will also evaluate whether adjuvant clodronate results in a reduction in the incidence of skeletal metastasis, skeletal-related morbidity, non-skeletal metastases, and an improvement in relapse-free survival and overall survival. To qualify for this trial, women must have undergone either a total mastectomy or a lumpectomy with either an axillary dissection or sentinel node biopsy. Patients will be stratified according to age, nodal status and ER and or PgR receptor status. Patients must have no evidence of metastatic disease. The administration of adjuvant chemotherapy and/or tamoxifen will be at the discretion of the investigator. The exact regimen, dose and duration will be at the discretion of the investigator and is not part of the study. It is the addition of either clodronate or placebo that is the subject of this study.
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