Histologically Confirmed Breast Cancer ,Diagnosis of Bone Metastasis
Conditions
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
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: 1. To observe whether zoledronic acid prolonged the time of first SREs in patients with bone metastasis; 2. 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. 3. To observe the clinical distribution, characteristics, timing and compliance of zoledronic acid administration in Chinese breast cancer patients with first bone metastasis.
Interventions
OTHERNon-intervention
Non-intervention,with real world study
Sponsors
Zhejiang Cancer Hospital
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 1\. 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
* 1\. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Contacts
Primary ContactXiaojia Wang, MD
Outcome results
None listed