Phase 3
N=1,822
Zoledronic Acid in Treating Patients With Metastatic Breast Cancer, Metastatic Prostate Cancer, or Multiple Myeloma With Bone Involvement
Breast Adenocarcinoma · DS Stage I Plasma Cell Myeloma · DS Stage II Plasma Cell Myeloma · Metastatic Malignant Neoplasm to the Bone · Pain
Bottom Line
View on ClinicalTrials.gov: NCT00869206 ↗Enrolled (actual)
1,822
Serious AEs
11.4%
Results posted
Nov 2018
Primary outcome: Primary: Percentage of Participants With at Least One Skeletal-related Event (SRE) Within 2 Years After Randomization — 67.6; 67.9 percentage of participants — p=<=.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- zoledronic acid (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alliance for Clinical Trials in Oncology
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With at Least One Skeletal-related Event (SRE) Within 2 Years After Randomization |
67.6; 67.9 | <=.05 |
| SECONDARY Average Pain Intensity Score as Assessed by the Brief Pain Inventory (BPI) Questionnaire |
2.06; 2.09 | 0.68 |
| SECONDARY Average ECOG Performance Status |
0.82; 0.84 | 0.64 |
| SECONDARY Incidence of Osteonecrosis of the Jaw |
2.0; 1.0 | — |
| SECONDARY Incidence of Renal Dysfunction |
1.2; .5 | 0.10 |
| SECONDARY Skeletal Morbidity Rate |
.4; .4 | — |
| SECONDARY Bone Turnover Assessed by Serum C-telopeptide (CTX) Levels (Breast Cancer) |
83; 75; 54; 54 | — |
| SECONDARY Proportion of Patients Having at Least One SRE Within 24 Months After Randomization for the Subgroups of Patients With Breast Cancer |
113; 119 | — |
| SECONDARY Proportion of Patients Having at Least One SRE Within 24 Months After Randomization for the Subgroups of Patients With Prostate Cancer |
107; 101 | — |
| SECONDARY Proportion of Patients Having at Least One SRE Within 24 Months After Randomization for the Subgroups of Patients With Multiple Myeloma |
35; 30 | — |
| SECONDARY Bone Turnover Assessed by Serum C-telopeptide (CTX) Levels (Prostate Cancer) |
34; 49; 70; 54 | — |
| SECONDARY Bone Turnover Assessed by Serum C-telopeptide (CTX) Levels (Multiple Myeloma) |
15; 19; 23; 17 | — |
Summary
This randomized phase III trial studies two different schedules of zoledronic acid to compare how well they work in reducing bone-related complications in patients with breast cancer, prostate cancer, or multiple myeloma that has spread to other places in the body and have bone involvement. Bone-related complications are a major cause of morbidity in patients with metastatic prostate cancer, breast cancer, and multiple myeloma. Zoledronic acid may stop the growth of cancer cells in the bone and may help relieve some of the symptoms caused by bone metastases. It is not yet known whether giving zoledronic acid more or less frequently is more effective in treating patients with metastatic cancer that has spread to the bone.
Eligibility Criteria
Eligibility Criteria:
- Histologic documentation of one of the following: breast adenocarcinoma, prostate adenocarcinoma or multiple myeloma
- At least one site of bone metastasis or bone involvement by radiologic imaging including plain radiograph, computed tomography (CT), positron emission tomography (PET) scan, PET/CT scan, magnetic resonance imaging, bone scan, or skeletal survey; indeterminate lesions should be confirmed by a second imaging method
- No prior treatment with IV bisphosphonates is allowed; prior treatment with oral bisphosphonates is allowed, but they must be discontinued prior to the initiation of protocol therapy
- No prior treatment with denosumab
- No prior treatment with radiopharmaceuticals; prior treatment with radioactive iodine is allowed; prostate cancer patients treated with brachytherapy are eligible
- Prior radiation therapy to bone is allowed, provided that at least one site of bone metastasis has not been irradiated and radiation is completed prior to registration; there should be no plan for radiation therapy to non-irradiated sites of bone metastases
- Prior adjuvant and metastatic chemotherapy, biologic therapy, and endocrine therapy is allowed
- No current treatment with investigational agent(s)
- Patients with known brain metastases are not eligible; patients who develop brain metastases during the study will be allowed to continue treatment as assigned
- Not pregnant and not nursing
- ECOG performance status 0-2
- Calculated creatinine clearance >= 30 mL/min
- Corrected serum calcium >= 8.0 mg/dL (2.00 mmol/L) and < 11.6 mg/dL (2.90 mmol/L) * Corrected serum calcium should be calculated using standard institutional practices
Data sourced from ClinicalTrials.gov (NCT00869206). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.