TRIAL COMPARING ADJUVANT CLODRONATE THERAPY VERSUS PLACEBO IN BREAST CANCER

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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 will evaluate the worth of clodronate, a second-generation biphosphonate, in women with early-stage breast cancer. 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. For patients undergoing sentinel node biopsy, only those participating in NSABP B-32 will be eligible. If sentinel node biopsy is performed outside the B-32 protocol, completion of axillary dissection is required. 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 and will be documented in the study record. The exact regimen, dose and duration wil be at the discretion of the investigator. Patients will be followed every six months for the first five years and every 12 months thereafter. In order to fully determine treatment effects on both bone and all other potential sites of recurrence, each patient will be followed for sites of recurrence until the development of both bone and non-bone metastasis (this includes visceral sites, soft tissue sites and/or local/regional recurrence sites) have occurred. Patients will continue their assigned therapy for three years or until first definite bone metastasis, even if the patient has had a prior non-skeletal recurrence or second primary cancer. The primary aims of this trial are: 1) to determine whether 1,600 mg/day of clodronate, given for three years, either alone or in addition to adjuvant chemotherapy and/or hormonal therapy will improve disease-free survival; 2) to evaluate whether adjuvant clodronate results in a reduction in skeletal metastases, skeletal-related morbidity, non-skeletal metastases, and an improvement in relapse-free survival and overall survival; and 3) to investigate the relevance of serum markers of bone turnover as a prognostic factor for the development of bone metastases.