Comparison of Two Schedules of Zoledronic Acid in Treating Patients With Breast Cancer That Has S… (NCT00458796) | Clinical Trial Compass
TerminatedNot Applicable
Comparison of Two Schedules of Zoledronic Acid in Treating Patients With Breast Cancer That Has Spread to the Bone
Stopped: Lower than expected recruitment
United Kingdom1,500 participantsStarted 2006-03
Plain-language 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.
Who can participate
Age range18 Years – 120 Years
SexALL
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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 CONCUR…
What they're measuring
1
Fractures
2
Radiotherapy to bone either for relief of pain or to treat or prevent pathological fractures or spinal cord compression
3
Hypercalcemia of malignancy
4
Orthopedic surgery to prevent or treat pathological fractures or spinal cord compression