Clinical trial · Interventional
Ibandronate or Zoledronate in Treating Patients With Newly Diagnosed Bone Metastases From Breast Cancer
Zoledronate Versus Ibandronate Comparative Evaluation: A Randomized Phase III, Open-Label, Multicenter, Parallel Group Clinical Trial to Evaluate and Compare the Efficacy, Safety Profile and Tolerability of Oral Ibandronate Versus Intravenous Zoledronate in the Treatment of Breast Cancer Patients With Bone Metastases
- 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)
RATIONALE: Ibandronate and zoledronate may help relieve some of the symptoms caused by bone metastases. It is not yet know whether ibandronate is more effective than zoledronate in treating bone metastases from breast cancer. PURPOSE: This randomized phase III trial is studying ibandronate to see how well it works compared with zoledronate in treating patients with newly diagnosed bone metastases from breast cancer.
Conditions
Conditions (3)
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 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ibandronate sodium | Drug | Ibandronic Acid | ALIAS |
| zoledronic acid | Drug | Zoledronic Acid | ALIAS |
| Zolendronic Acid | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Ibandronic Acid
- description
- 50mg tablet once daily over 96 weeks
- interventionNames
- Drug: ibandronate sodium
- type
- ACTIVE_COMPARATOR
- label
- Zoledronic Acid
- description
- 4 mg via intravenous infusion (iv) over a minimum of 15 minutes in at least 100mls of saline every 4 weeks over 96 weeks
- interventionNames
- Drug: zoledronic acid
- Drug: Zolendronic Acid
Primary outcomes (1)
- measure
- Frequency and timing of skeletal-related events (SREs)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically proven breast cancer * Metastatic disease * Previous relapsed disease in sites other than bone allowed * Newly diagnosed multiple bone metastases within the past 3 months, meeting all of the following criteria: * Painful or asymptomatic * Lytic, mixed, or purely sclerotic type * Radiological diagnosis * IV bisphosphonate therapy indicated * No CNS metastases * Hormone receptor status not specified PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Male or female * Menopausal status not specified * No known active peptic ulcer * Not pregnant or nursing * Fertile patients must use effective contraception * No active dental problems, including infection of the teeth or jawbone (maxilla or mandible) or dental or fixture trauma * No prior or current diagnosis of osteonecrosis of the jaw, exposed bone in the mouth, or slow healing after dental procedures * Creatinine clearance ≥ 30 mL/min * Bilirubin ≤ 1.5 x upper limit of normal (ULN) * AST and ALT ≤ 1.5 times ULN * No history of bisphosphonate hypersensitivity * Able to comply with instructions relating to oral study medications * Able to take oral study medications * No psychiatric illness or other condition that would preclude giving informed consent PRIOR CONCURRENT THERAPY: * At least 6 months since prior bisphosphonate therapy * At least 6 weeks since prior and no concurrent dental or jaw surgery (e.g., extractions or implants) * Concurrent unplanned dental extractions allowed provided study medication is discontinued for 8 weeks before and after the surgery * Concurrent chemotherapy and/or hormone therapy for metastatic disease allowed * No concurrent medications that affect bone metabolism (e.g., calcitonin or other nontrial bisphosphonates)
References
Publications (2)
- DERIVEDGillespie D, Farewell D, Barrett-Lee P, Casbard A, Hawthorne AB, Hurt C, Murray N, Probert C, Stenson R, Hood K. The use of randomisation-based efficacy estimators in non-inferiority trials. Trials. 2017 Mar 9;18(1):117. doi: 10.1186/s13063-017-1837-3. PMID 28274254
- DERIVEDBarrett-Lee P, Casbard A, Abraham J, Hood K, Coleman R, Simmonds P, Timmins H, Wheatley D, Grieve R, Griffiths G, Murray N. Oral ibandronic acid versus intravenous zoledronic acid in treatment of bone metastases from breast cancer: a randomised, open label, non-inferiority phase 3 trial. Lancet Oncol. 2014 Jan;15(1):114-22. doi: 10.1016/S1470-2045(13)70539-4. Epub 2013 Dec 11. PMID 24332514