Ibandronate or Zoledronate in Treating Patients With Newly Diagnosed Bone Metastases From Breast Cancer

• Status: Unknown status
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wales Cancer Trials Unit
• Collaborator: Velindre NHS Trust
• Treatments: Diphosphonates; Ibandronic Acid; Zoledronic Acid

Criteria

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 dental extractions allowed provided study medication is discontinued for 8 weeks before and after the surgery

• Concurrent chemotherapy and/or hormone therapy for metastatic disease allowed

• No concurrent medications that affect bone metabolism (e.g., calcitonin or other nontrial bisphosphonates)