TRIAL COMPARING ADJUVANT CLODRONATE THERAPY VERSUS PLACEBO EARLY 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. Systemic therapy with cytotoxic drugs and hormones has been shown to delay relapse and to improve survival in all groups of women with breast cancer. Despite these successes, more than one-third of women with carcinoma of the breast may eventually relapse. Bone is a common site of relapse, accounting (either alone or concomitantly with other sites) for one-quarter to one-third of initial sites of relapse and is second in frequency only to loco-regional recurrence as a first site. Approximately 1/3 of all patients who develop bone metastasis also have disease at other sites. Among those patients that recur, as the disease progresses, almost 70% develop radiological evidence of bone metastases with the attendant clinical sequelae of fracture, pain, and hypercalcemia occurring in the majority. Node-positive patients had higher rates of bone recurrence than did node-negative patients, and ER-positive patients had higher rates of bone recurrence than ER-negative patients, despite ER-positive patients having a lower rate of overall distant recurrence than did ER-negative patients. Bone metastases are, therefore, a major cause of morbidity and mortality in women with carcinoma of the breast. The study aims are to: 1) determine whether clodronate administered for three years either alone or in addition to adjuvant chemotherapy and/or hormonal therapy, in patients with early-stage breast cancer will improve disease-free survival; 2) determine whether clodronate will reduce the incidence of skeletal metastases, improve overall survival, improve relapse-free survival, reduce the incidence of non-skeletal metastases, and reduce the incidence of skeletal morbidity (skeletal fractures, hypercalcemia, skeletal pain, need for radiation therapy, spinal cord compression); and 3) investigate the relevance of serum markers of bone turnover as a prognostic factor for the development of bone metastasis.