Clinical trial · Interventional
Comparison of Two Schedules of Zoledronic Acid in Treating Patients With Breast Cancer That Has Spread to the Bone
Cost-Effective Use of Bisphosphonates in Metastatic Bone Disease - A Comparison of Bone Marker Directed Zoledronic Acid Therapy to a Standard Schedule
NCT00458796CI-TRIAL-00058775terminatedN/AClinicalTrials.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): Lower than expected recruitment
Summary
Brief summary (as posted)
RATIONALE: Zoledronic acid may help decrease the risk of broken bones, bone pain, and other symptoms caused by bone metastases. It may also help patients live more comfortably. PURPOSE: This randomized clinical trial is studying different schedules of zoledronic acid to compare how well they work in treating patients with breast cancer that has spread to the bone.
Conditions
Conditions (5)
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 |
| Hypercalcemia of Malignancy | — | UNRESOLVED | — |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Musculoskeletal Complications | — | UNRESOLVED | — |
| Pain | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| zoledronic acid | Drug | Zoledronic Acid | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (5)
- measure
- Fractures
- measure
- Radiotherapy to bone either for relief of pain or to treat or prevent pathological fractures or spinal cord compression
- measure
- Hypercalcemia of malignancy
- measure
- Orthopedic surgery to prevent or treat pathological fractures or spinal cord compression
- measure
- Spinal cord compression
Secondary outcomes (8)
- measure
- Quality of life as measured by QLQ-C30 and the QLQ-BR23 breast-specific module
- measure
- Clinical burden of skeletal complications
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed primary breast cancer * Advanced disease * Radiographic confirmation of bone metastases (≥ 1 bone scan lesion must be confirmed as metastatic by plain radiographs or CT scan/MRI) * Must have received zoledronic acid to treat metastatic bone disease (i.e., ≥ 4 or 5 zoledronic acid treatments prior to study entry for patients receiving 4- or 3-weekly infusions, respectively) for ≥ 4 months prior to study entry * Any bisphosphonate to treat metastatic bone disease allowed provided it was not given for more than 12 months prior to study entry * No metabolic bone disease (e.g., Paget's disease of bone) * Osteoporosis allowed * No brain metastases * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Male or female * Menopausal status not specified * WHO or ECOG performance status 0-2 * Life expectancy ≥ 6 months * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * AST and ALT ≤ 3 times upper limit of normal (ULN) * Bilirubin ≤ 1.5 times ULN * Creatinine clearance ≥ 30 mL/min * No poor venous access * No concurrent active dental problems, including infection of the teeth or jawbone (maxilla or mandibular) * No prior or current diagnosis of osteonecrosis of the jaw * No other cancer within the past 5 years except nonmelanomatous skin cancer, carcinoma in situ of the uterine cervix, or superficial bladder cancer treated with curative intent PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No other prior bisphosphonate treatment within the past 3 weeks * No treatment with systemic bone-seeking radioisotopes (e.g., strontium chloride Sr 89, samarium Sm 153 lexidronam pentasodium) within the past 3 months * No wide-field (hemibody) radiotherapy within the past 3 months * Recent standard-field, localized radiotherapy allowed * No dental or jaw surgery (e.g., extractions, implants) within the past 4 weeks * No other concurrent bisphosphonates * No concurrent medication with drugs known to affect bone metabolism (e.g., calcitonin or high-dose systemic corticosteroids \[\> 10 mg prednisolone/day or equivalent\]) * Systemic or oral corticosteroids allowed for clearly indicated conditions (e.g., chemotherapy-induced emesis, brain metastases, compression syndromes) * Concurrent chemotherapy, biological therapy, or endocrine therapy allowed
References
Publications (0)
Data not yet available
No reference posted for this study.