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

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