Clinical trial · Interventional
Zoledronic Acid Administration to Metastatic Breast Cancer Patients With Non-symptomatic Bone Lesions
Multicenter, Open-label, Randomized Phase III Trial for Administration of Zoledronate to Breast Cancer Metastatic Patients With Non-symptomatic Bone Lesions
NCT00130494CI-TRIAL-00038127terminatedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low recruitment
Summary
Brief summary (as posted)
This is an open-label, randomized, multicenter phase III trial to assess the efficacy of early administration of zoledronate versus observation in delaying bone-related symptoms in metastatic breast cancer patients.
Conditions
Conditions (2)
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 | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Neoplasm Metastasis | Breast Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Zoledronic acid | Drug | Zoledronic Acid | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A: Zoledronic acid 4 mg
- description
- Zoledronate 4 mg every 3 or 4 weeks. This arm will receive study treatment from the time of entry into the trial, until the appearance of the symptoms of bone metastases (or a maximum period of 12 months, whichever occurs first).
- interventionNames
- Drug: Zoledronic acid
- type
- NO_INTERVENTION
- label
- Arm B: Observation
- description
- Patients will not receive any treatment with bisphosphonates until the time of onset of symptoms (or a maximum period of 12 months, whichever occurs sooner).
Primary outcomes (1)
- measure
- Time to first bone metastases
- timeFrame
- Up to disease progression
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent. * Age \>= 18 years old. * Metastatic breast cancer patients with lytic, sclerotic or mixed bone lesions. * Non-symptomatic bone lesions, defined as pain absence, lack of bone complications (fracture, hypercalcemia, Central Nervous System (CNS) compression), no need of analgesic chronic administration for bone disease. * A maximum of two chemotherapy lines for metastatic disease. * A maximum of two hormone therapy lines for metastatic disease. * Normal, minimally altered renal function (serum creatinine \< 1.5 x Upper Normal Limit (UNL)). * Normal serum calcium levels. * Performance status 0,1 (World Health Organization (WHO)). * Negative pregnancy test before study recruitment. Exclusion Criteria: * Previous treatment with bisphosphonates or raloxifene in the 30 days prior to randomization. * Metastasis in CNS. * History of hypersensitivity to bisphosphonates. * Pregnant or lactating women. * Third chemotherapy line for metastatic disease. * Third hormone therapy line for metastatic disease. * Males.
References
Publications (0)
Data not yet available
No reference posted for this study.