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

NCT ID: NCT05480189

Last Updated: 2022-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-30

Study Completion Date

2027-03-31

Brief Summary

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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

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(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.

Conditions

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Histologically Confirmed Breast Cancer ,Diagnosis of Bone Metastasis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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patients in breast cancer with bone metastasis

patients in breast cancer with bone metastasis

Non-intervention

Intervention Type OTHER

Non-intervention,with real world study

Interventions

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Non-intervention

Non-intervention,with real world study

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhejiang Cancer Hospital

OTHER

Sponsor Role lead

Responsible Party

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Wang Xiaojia

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiaojia Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Zhejiang Cancer Hospital

Central Contacts

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Xiaojia Wang, MD

Role: CONTACT

Phone: 13906500190

Email: [email protected]

Other Identifiers

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IRB-2022-166

Identifier Type: -

Identifier Source: org_study_id