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NCT Number: NCT05480189

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

(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:

  • To observe whether zoledronic acid prolonged the time of first SREs in patients with bone metastasis;
  • 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.
  • To observe the clinical distribution, characteristics, timing and compliance of zoledronic acid administration in Chinese breast cancer patients with first bone metastasis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-intervention

Other

Non-intervention,with real world study

Primary outcomes

  1. SREs

    Time frame: 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 outcomes

  1. time to first on-study SRE

    Time frame: 3 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaojia Wang, MD

CONTACT

[email protected]

13906500190

Sponsors and collaborators

Lead sponsor

Zhejiang Cancer Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2027
First posted
Jul 29, 2022
Registry last updated
Jul 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.