Ibandronate or Zoledronate in Treating Patients With Newly Diagnosed Bone Metastases From Breast … (NCT00326820) | Clinical Trial Compass
UnknownPhase 3
Ibandronate or Zoledronate in Treating Patients With Newly Diagnosed Bone Metastases From Breast Cancer
United Kingdom1,404 participantsStarted 2006-01
Plain-language summary
RATIONALE: Ibandronate and zoledronate may help relieve some of the symptoms caused by bone metastases. It is not yet know whether ibandronate is more effective than zoledronate in treating bone metastases from breast cancer.
PURPOSE: This randomized phase III trial is studying ibandronate to see how well it works compared with zoledronate in treating patients with newly diagnosed bone metastases from breast cancer.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Histologically proven breast cancer
* Metastatic disease
* Previous relapsed disease in sites other than bone allowed
* Newly diagnosed multiple bone metastases within the past 3 months, meeting all of the following criteria:
* Painful or asymptomatic
* Lytic, mixed, or purely sclerotic type
* Radiological diagnosis
* IV bisphosphonate therapy indicated
* No CNS metastases
* Hormone receptor status not specified
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Male or female
* Menopausal status not specified
* No known active peptic ulcer
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No active dental problems, including infection of the teeth or jawbone (maxilla or mandible) or dental or fixture trauma
* No prior or current diagnosis of osteonecrosis of the jaw, exposed bone in the mouth, or slow healing after dental procedures
* Creatinine clearance ≥ 30 mL/min
* Bilirubin ≤ 1.5 x upper limit of normal (ULN)
* AST and ALT ≤ 1.5 times ULN
* No history of bisphosphonate hypersensitivity
* Able to comply with instructions relating to oral study medications
* Able to take oral study medications
* No psychiatric illness or other condition that would preclude giving informed consent
PRIOR CONCURRENT THERAPY:
* At least 6 months since prior bisphosphonate therapy
* At least 6 weeks since prior and no concurrent dental or jaw surgery (e.g., extractions or implants)
* Concurrent unplanned denta…
What they're measuring
1
Frequency and timing of skeletal-related events (SREs)