Clinical trial · Interventional
Safety/Efficacy of Intravenous Zoledronic Acid When Added to Standard Therapies in Patients With Breast Cancer and Metastatic Bone Lesions
Efficacy and Tolerability of Intravenous Zoledronic Acid 4mg as an Adjunct to Standard Therapies Including Conversion From Pamidronate in Breast Cancer Patients With Metastatic Bone Lesions. A Prospective, Randomised, Open-label, Clinical Study
NCT00372710CI-TRIAL-00002811terminatedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Zoledronic acid selectively binds to bone and protects it from being metastasized by tumor cells. This study evaluates the safety and efficacy of zoledronic acid when added to standard therapies in breast cancer patients with metastatic bone lesions.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer With Bone Metastasis | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Zoledronic acid | Drug | Zoledronic Acid | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Efficacy of a switch over from pamidronate therapy (2 infusions) to a treatment with zoledronic acid 4mg every 4 weeks (10 infusions) for 44 weeks in patients with breast cancer-related bone lesions
Secondary outcomes (1)
- measure
- Comparison of the safety, tolerability, and efficacy in the treatment arms
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria * Confirmed diagnosis of Breast Cancer with at least one breast cancer-related bone lesion * No treatment with bisphosphonates within 6 months prior to inclusion into the study * Good health status (ECOG Performance status 0-2) Exclusion criteria * Patients who do not have at least one breast cancer-related bone lesion that is detectable on conventional radiographs of bone (plain film) at screening * Abnormal renal function * History of diseases with influence on bone metabolism such as Paget's disease and primary hyperparathyroidism * Pregnancy and lactation * Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current 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)
References
Publications (0)
Data not yet available
No reference posted for this study.