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

Not yet recruiting

• Conditions: Histologically Confirmed Breast Cancer ,Diagnosis of Bone Metastasis
• Interventions: Other: Non-intervention

• Registration Number: NCT05480189
• Lead Sponsor: Zhejiang Cancer Hospital

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.

Study Timeline

• Status Verified: 2022-07
• Study First Submitted: 2022-07-26
• Study First Submitted QC: 2022-07-26
• Last Update Submitted: 2022-07-26
• Study First Posted: 2022-07-29
• Last Update Posted: 2022-07-29
• Study Start: 2022-08-30
• Primary Completion: 2023-08-30
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients in breast cancer with bone metastasis	Non-intervention	patients in breast cancer with bone metastasis

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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