A Prospective, Randomized, Multi-center Comparative 2-arm Trial of Efficacy and Safety of Zoledronic Acid (Every 3-months vs. Every 4 Weeks) Beyond Approximately 1 Year of Treatment With Zoledronic Acid in Patients With Bone Lesions From Breast Cancer
Overview
- Phase
- Phase 3
- Intervention
- Zoledronic acid
- Conditions
- Breast Cancer With Bone Metastasis
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 430
- Locations
- 1
- Primary Endpoint
- Annual Overall Skeletal Morbidity Rate (SMR)
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Every 3 months
Zoledronic acid as a 15-minute (at least) intravenous (i.v.) infusion every three months. 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. Randomized patients will receive a maximum of 4 infusions in this group.
Intervention: Zoledronic acid
Every 4 weeks
Zoledronic acid as a 15-minute (at least) intravenous (i.v.) infusion every 4 weeks. 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. Patients randomized to this group will receive up to 12 infusions.
Intervention: Zoledronic acid
Outcomes
Primary Outcomes
Annual Overall Skeletal Morbidity Rate (SMR)
Time Frame: 12 months
The SMR was computed by summing all Skeletal Related Event(s) (SREs)which occurred during the observation period and dividing it by the ratio "days of observation period / 365.25", for each participant. SRE was defined as: pathologic bone fracture, spinal cord compression, surgery to bone both curative and prophylactic, radiation therapy to bone, or hypercalcemia of malignancy. SMR (years) = 365.25 x SMR(days) where SMR (days) = total number of SREs / total SRE risk period (days). Risk period for SMR was computed as the days from randomization date to the date of last visit.
Secondary Outcomes
- Evaluation of Pain According to Verbal Rating Scale (VRS) Based on Median Score Value(At Baseline, Month 3, Month 6, Month 9 and Month 12)
- Percentage of Participants Experiencing Skeletal Related Event(s) (SREs)(12 month)
- Median Time to First Skeletal Related Event(s) (SRE)(12 month)
- Annual Incidence of Any Skeletal Related Events (SREs)(12 months)
- Percentage of Participants Skeletal Related Event (SRE) Free(12 months)
- Use Of Analgesic Medications According to the Analgesic Score Scale(At Baseline, Month 3, Month 6, Month 9 and Month 12)
- Assessment of the Eastern Cooperative Oncology Group (ECOG) Performance Score(At Baseline, Month 3, Month 6, Month 9 and Month 12)
- Composite Bone Pain Score According to the Brief Pain Inventory (BPI) Questionnaire(At Baseline, Month 3, Month 6, Month 9 and Month 12)