Effect of Zoledronic Acid Treatment on Bone-related Events in Breast Cancer Patients With Bone Metastases: a Prospective, Multicenter, Real-world Study
Study Details
Study Description
Brief Summary
non-intervention、real world study； Effect of timing and regular treatment of zoledronic acid on the incidence of SREs in breast cancer patients
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
(1) Main Purpose: To observe the clinical efficacy of zoledronic acid regularly in the prevention of SREs in breast cancer patients with bone metastasis (2) Secondary Objectives:
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To observe whether zoledronic acid prolonged the time of first SREs in patients with bone metastasis;
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The clinical efficacy and influencing factors of zoledronic acid in different subgroups were observed by subgroup analysis of population baseline, clinical characteristics (such as different types of breast cancer), past history and complications.
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To observe the clinical distribution, characteristics, timing and compliance of zoledronic acid administration in Chinese breast cancer patients with first bone metastasis.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| patients in breast cancer with bone metastasis patients in breast cancer with bone metastasis |
Other: Non-intervention
Non-intervention,with real world study
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Outcome Measures
Primary Outcome Measures
- SREs [3 years]
skeletal-related events (SREs) including pathologic fracture, spinal cord compression, hypercalcemia of malignancy, and the need for radiotherapy and/or surgery to bone
Secondary Outcome Measures
- time to first on-study SRE [3 years]
time to first on-study SRE defined as pathologic fracture, radiation or surgery to bone, or spinal cord compression
Eligibility Criteria
Criteria
Inclusion Criteria:
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- Age ≥18 years 2. Histologically confirmed breast cancer 3. Initial diagnosis of bone metastasis by MRI or CT and treatment with zoledronic acid 4. Serum creatinine ≤265mol/L or 3.0mg/dl 5. CrCl ≥ 30 ml/min 6. Serum Ca2+ concentration 2.0-3.0 mmonl/L 7.ECOG score ≤2 Voluntary research, informed consent
Exclusion Criteria:
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- Pregnant and lactating women 2. Severe liver insufficiency (ALT and/or AST higher than 3 times the upper limit of normal) 3. Patients with osteoarthritis or other bone related diseases need bone targeted therapy 4. Patients with uncontrolled dental problems or planned jaw surgery
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Zhejiang Cancer Hospital
Investigators
- Principal Investigator: Xiaojia Wang, MD, Zhejiang Cancer Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB-2022-166