Phase 3
N=425
Safety and Efficacy of Zoledronic Acid in Patients With Breast Cancer With Metastatic Bone Lesions
Breast Cancer With Bone Metastasis
Bottom Line
View on ClinicalTrials.gov: NCT00375427 ↗Enrolled (actual)
425
Serious AEs
11.8%
Results posted
Aug 2011
Primary outcome: Primary: Annual Overall Skeletal Morbidity Rate (SMR) — 0.26; 0.22 Number of Skeletal Events per Year
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Zoledronic acid (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Feb 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Annual Overall Skeletal Morbidity Rate (SMR) |
0.26; 0.22 | — |
| SECONDARY Percentage of Participants Experiencing Skeletal Related Event(s) (SREs) |
14.83; 15.28; 1.44; 1.85; 3.35; 2.31 | — |
| SECONDARY Annual Incidence of Any Skeletal Related Events (SREs) |
0.02; 0.02; 0.08; 0.03; 0.01; 0.00 | — |
| SECONDARY Median Time to First Skeletal Related Event(s) (SRE) |
NA; NA | — |
| SECONDARY Percentage of Participants Skeletal Related Event (SRE) Free |
99; 98; 98; 98; 96; 97 | — |
| SECONDARY Composite Bone Pain Score According to the Brief Pain Inventory (BPI) Questionnaire |
2.0; 2.1; 2.3; 2.2; 2.3; 1.9 | — |
| SECONDARY Evaluation of Pain According to Verbal Rating Scale (VRS) Based on Median Score Value |
1; 1; 2; 2; 2; 1 | — |
| SECONDARY Use Of Analgesic Medications According to the Analgesic Score Scale |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Assessment of the Eastern Cooperative Oncology Group (ECOG) Performance Score |
0; 0; 0; 0; 0; 0 | — |
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) 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.
Data sourced from ClinicalTrials.gov (NCT00375427). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.