Real World Study of Bone Metastases in Patients with Advanced Breast Cancer

NCT ID: NCT06873997

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 737 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2024-12-01

Brief Summary

By analyzing the clinical data of patients with advanced breast cancer with bone metastasis admitted to our center from January 1, 2021 to February 28, 2023, this study aims to understand the real-world clinical diagnosis and treatment of breast cancer with bone metastasis, including the epidemiology of bone metastasis, screening and diagnosis methods, selection of clinical treatment methods, and occurrence of SRE. To explore the risk factors related to bone metastasis-free survival (BMFI). In addition, we will explore the use of quantitative analysis of CT values to evaluate bone metastases of breast cancer, aiming to provide a new method for imaging quantitative efficacy evaluation of bone metastases.

Detailed Description

The specific contents of our research include the basic information of breast cancer patients with bone metastasis in the early stage, neoadjuvant therapy, surgery and postoperative pathology, and adjuvant therapy; The time and location of recurrence and metastasis, treatment plan, and information related to bone metastasis include time, location, diagnosis method, treatment, occurrence of SRE, and changes in CT values of bone lesions before and after drug treatment. The objective is to understand the risk factors of bone metastasis-free survival (BMFI) of breast cancer patients with bone metastases in the real world, provide evidence and data for clinical accurate screening, observe the CT value changes of bone lesions through imaging (CT quantitative), and explore a new method for evaluating the efficacy of bone metastases.

Conditions

Breast Cancer Metastatic

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

1. Age ≥18y;

2. Advanced breast cancer is clearly diagnosed;

3. Imaging or pathology confirmed at least 1 bone metastasis;

4. No history of other malignant tumors at the time of initial diagnosis;

5. The physical status score of Eastern Tumor Collaboration Group (ECOG) was ≤2 points;

6. Complete clinical and follow-up data.

Exclusion Criteria

1. Patients with other malignant tumors;

2. History of hyperthyroidism and hypothyroidism, abnormal parathyroid function;

3. History of bone metabolic diseases.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Wang Xiaojia

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Zhejiang Cancer Hospital

Zhejiang, , China

Countries

China

Other Identifiers

IRB-2023-692

Identifier Type: -

Identifier Source: org_study_id