Safety and Efficacy of Zoledronic Acid in Patients With Breast Cancer With Metastatic Bone Lesions
Condition: Breast Cancer With Bone Metastasis
MeSH terms: Breast Neoplasms
Intervention: Zoledronic acid
Intervention description: Zoledronic acid as a 15-minute (at least) intravenous (i.v.) infusion. The dose of study drug will be the same administered before the study entry, that is 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg.
Intervention MeSH terms: Zoledronic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 430.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast cancer; Zoledronic acid; Skeletal related events (SRE)

Summary:

      The objective of this study is to assess the clinical benefit of two different dosing
      schedules of zoledronic acid in patients with metastatic bone lesions from breast cancer who
      have already been treated with zoledronic acid for about one year.
    

Eligibility criteria:

        Inclusion criteria:

          -  Female patients ≥ 18 years of age.

          -  Written informed consent given.

          -  Histologically confirmed Stage IV breast cancer with at least one bone metastasis
             radiologically confirmed.

          -  Previous treatment with zoledronic acid every 3-4 weeks, for 9-12 infusions over no
             more than 15 months.

          -  Eastern Cooperative Oncology Group (ECOG) performance status ≤2 .

          -  Life expectancy ≥ 1 year.

        Exclusion criteria:

          -  More than 3 months since last infusion of Zoledronic Acid (Zometa®).

          -  Treatments with other bisphosphonate than Zoledronic Acid (Zometa®) at any time prior
             to study entry.

          -  Serum creatinine > 3 mg/dL (265 μmol/L) or calculated (Cockcroft-Gault formula)
             creatinine clearance (CLCr) < 30 mL/min CrCl = ({[140-age (years)] x weight(kg)}/ [72
             x serum creatinine (mg/dL)])x 0.85

          -  Corrected (adjusted for serum albumin) serum calcium < 8 mg/dl (2 mmol/L) or > 12
             mg/dL ( 3.0 mmol/L).

          -  Current active dental problem including infection of the teeth or jawbone (maxilla or
             mandibular); dental or fixture trauma, or a recurrent or prior diagnosis of
             osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after
             dental procedures.

          -  Recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants).

          -  Pregnant patients (with a positive pregnancy test prior to study entry) or lactating
             patients. Women of childbearing potential not using effective methods of birth control
             (e.g. abstinence, oral contraceptives or implants, IUD, vaginal diaphragm or sponge,
             or condom with spermicide).

          -  History of non-compliance to medical regimens or potential unreliable behavior.

          -  Known sensitivity to study drug(s) or class of study drug(s).

          -  Patients with severe medical condition(s) that in the view of the investigator
             prohibits participation in the study

          -  Use of any other investigational agent in the last 30 days.