S0307 Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer.

Inclusion criteria

DISEASE CHARACTERISTICS: * Histologically confirmed primary adenocarcinoma of the breast * Stage I-III disease * No evidence of metastatic disease * Must have undergone lumpectomy or total mastectomy for primary disease within the past 12 weeks, or have completed chemotherapy within the past 8 weeks * Axillary evaluation per institutional standards * Currently receiving or planning to receive standard adjuvant systemic therapy comprising chemotherapy, hormonal therapy, or combined chemotherapy/hormonal therapy for breast cancer * Patients who are at low risk for disease recurrence and for whom adjuvant systemic therapy will not be prescribed are not eligible * Patients who receive biologic agents only or local radiotherapy only (without chemotherapy and/or hormone therapy) are not eligible * Additional therapies are allowed including radiotherapy and biologic agents (e.g., trastuzumab \[Herceptin\^®\], bevacizumab, or hematopoietic growth factors) * Neoadjuvant therapy or hormonal therapy alone is allowed provided study entry occurs ≥ 12 weeks after completion of surgery * Patients with skeletal pain are eligible provided bone scan and/or roentgenological exam are negative for metastatic disease * Suspicious findings must be confirmed as benign by x-ray, MRI, or biopsy * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * 18 and over Sex * Female Menopausal status * Not specified Performance status * Zubrod 0-2 Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Creatinine ≤ 2 times upper limit of normal * Creatinine clearance ≥ 30 mL/min * No renal failure Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No history of esophageal stricture or motility disorders * Gastroesophageal reflux disorder allowed * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission PRIOR CONCURRENT THERAPY: Biologic therapy * Prior or concurrent hematopoietic growth factors allowed * HER-2-targeted therapies allowed * Antiangiogenics allowed Chemotherapy * See Disease Characteristics Endocrine therapy * See Disease Characteristics Radiotherapy * Concurrent radiotherapy to the breast, chest wall, or lymph node group allowed at the discretion of the treating physician Surgery * See Disease Characteristics Other * Prior neoadjuvant therapy allowed * Prior bisphosphonates for bone density allowed * No other concurrent bisphosphonates as adjuvant therapy or for treatment of osteoporosis * No concurrent enrollment in clinical trials with bone density as an endpoint * Concurrent enrollment on any other locoregional or systemic therapy breast cancer study (including cooperative group studies) allowed