Clinical trial · Interventional
Pamidronate Administration in Breast Cancer Patients With Bone Metastases
Randomized, Multicentric Phase IV Clinical Trial for the Administration of Pamidronate in Breast Cancer Patients With Bone Metastases
NCT00128297CI-TRIAL-00065063completedPhase 4ClinicalTrials.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)
The study objective is to evaluate the differences, in terms of first occurrence of a skeletal event, in patients with breast cancer and symptomatic bone metastases, when pamidronate is administered during 2 years, or when it is administered during 6 months, followed by a six month rest period, and again a 6 month treatment period.
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 |
|---|---|---|---|
| Pamidronate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm A: continuous administration
- description
- Pamidronate 90 mg/m2 iv every 3-4 weeks, during 18 months
- interventionNames
- Drug: Pamidronate
- type
- EXPERIMENTAL
- label
- Arm B: alternate administration
- description
- Pamidronate 90 mg/m2 iv every 3-4 weeks, during 6 months, followed by a 6 month rest, and a new 6 months treatment period.
- interventionNames
- Drug: Pamidronate
Primary outcomes (1)
- measure
- Pamidronate efficacy to prevent first skeletal event: time until the appearance of the first skeletal event
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent. * Up to two previous or current hormone therapy treatments for metastatic breast cancer are allowed. * Normal or borderline renal function (serum creatinine \< 1.5 x upper normal limit \[UNL\]). * Normal calcium levels in serum, or slightly non-symptomatic high levels (\< 1.25 x UNL). * Performance status 0, I or II in World Health Organization (WHO) scale. Exclusion Criteria: * Treatment with bisphosphonates in the 30 previous days, or any time if the indication was treatment of metastatic bone lesions. * Treatment with bisphosphonates is only allowed if the indication is hypercalcaemia. * Metastases in central nervous system (CNS). * Hypersensitivity to bisphosphonates or other components of the formula. * Pregnant or lactating women. * Previous or current treatment with a second chemotherapy line or a third hormone therapy line for metastatic disease.
References
Publications (0)
Data not yet available
No reference posted for this study.