Comparison of Two Schedules of Zoledronic Acid in Treating Patients With Breast Cancer That Has Spread to the Bone

This is an interventional supportive care trial for Breast Cancer focused on measuring hypercalcemia of malignancy, musculoskeletal complications, pain, stage IV breast cancer, male breast cancer, recurrent breast cancer, bone metastases Read More

DISEASE CHARACTERISTICS:

• Histologically confirmed primary breast cancer

  • Advanced disease

• Radiographic confirmation of bone metastases (≥ 1 bone scan lesion must be confirmed as metastatic by plain radiographs or CT scan/MRI)

  • Must have received zoledronic acid to treat metastatic bone disease (i.e., ≥ 4 or 5 zoledronic acid treatments prior to study entry for patients receiving 4- or 3-weekly infusions, respectively) for ≥ 4 months prior to study entry
  • Any bisphosphonate to treat metastatic bone disease allowed provided it was not given for more than 12 months prior to study entry

• No metabolic bone disease (e.g., Paget's disease of bone)

  • Osteoporosis allowed
• No brain metastases
• Hormone receptor status not specified

PATIENT CHARACTERISTICS:

• Male or female
• Menopausal status not specified
• WHO or ECOG performance status 0-2
• Life expectancy ≥ 6 months
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• AST and ALT ≤ 3 times upper limit of normal (ULN)
• Bilirubin ≤ 1.5 times ULN
• Creatinine clearance ≥ 30 mL/min
• No poor venous access
• No concurrent active dental problems, including infection of the teeth or jawbone (maxilla or mandibular)
• No prior or current diagnosis of osteonecrosis of the jaw
• No other cancer within the past 5 years except nonmelanomatous skin cancer, carcinoma in situ of the uterine cervix, or superficial bladder cancer treated with curative intent

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No other prior bisphosphonate treatment within the past 3 weeks
• No treatment with systemic bone-seeking radioisotopes (e.g., strontium chloride Sr 89, samarium Sm 153 lexidronam pentasodium) within the past 3 months

• No wide-field (hemibody) radiotherapy within the past 3 months

  • Recent standard-field, localized radiotherapy allowed
• No dental or jaw surgery (e.g., extractions, implants) within the past 4 weeks
• No other concurrent bisphosphonates

• No concurrent medication with drugs known to affect bone metabolism (e.g., calcitonin or high-dose systemic corticosteroids [> 10 mg prednisolone/day or equivalent])

  • Systemic or oral corticosteroids allowed for clearly indicated conditions (e.g., chemotherapy-induced emesis, brain metastases, compression syndromes)
• Concurrent chemotherapy, biological therapy, or endocrine therapy allowed