Effect of Zoledronic Acid Treatment on Bone-related Events in Breast Cancer Patients With Bone Metastases: a Prospective, Multicenter, Real-world Study

N/ANot Yet RecruitingNCT05480189

Zhejiang Cancer Hospital1,000 enrolled

Overview

non-intervention、real world study； Effect of timing and regular treatment of zoledronic acid on the incidence of SREs in breast cancer patients

(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.

Study Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Histologically Confirmed Breast Cancer ,Diagnosis of Bone Metastasis

Interventions

Non-interventionOTHER

Non-intervention,with real world study

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

SREs

skeletal-related events (SREs) including pathologic fracture, spinal cord compression, hypercalcemia of malignancy, and the need for radiotherapy and/or surgery to bone

Time frame: 3 years

Secondary Outcomes

time to first on-study SRE

time to first on-study SRE defined as pathologic fracture, radiation or surgery to bone, or spinal cord compression

Time frame: 3 years

Central Contacts

Xiaojia Wang, MD

CONTACT

13906500190 wxiaojia0803@163.com

Data from ClinicalTrials.gov

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