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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Zoledronic acid may help decrease the risk of broken bones, bone pain, and other symptoms caused by bone metastases. It may also help patients live more comfortably.

PURPOSE: This randomized clinical trial is studying different schedules of zoledronic acid to compare how well they work in treating patients with breast cancer that has spread to the bone.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Leeds
• Treatments: Diphosphonates; Zoledronic Acid

Criteria

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