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

NCT06873997 | Completed

• 1 other identifier: IRB-2023-692
• Study Type: observational
• Target: 737
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Metastatic

Outcome Measures

Primary Outcomes (1)

• Bone metastasis-free interval (BMFI) of breast cancer patients with bone metastasis

  Bone metastasis-free interval (BMFI) is the time between diagnosis of breast cancer and the onset of bone metastases

  From the diagnosis of breast cancer to the occurrence of bone metastasis，assessed up to 100 months

Secondary Outcomes (4)

• Number of participants with Clinical features of bone metastasis

  From the diagnosis of breast cancer to the conclusion of the study period，assessed up to 100 months

• Changes of CT values of bone lesions before and after treatment with bone protective drugs

  From the start of treatment with bone care drugs to 1 year

• Patterns of bone metastasis in the center

  rom the diagnosis of breast cancer to the occurrence of bone metastasis,assessed up to 100 months

• Occurrence of bone-related events

  From the diagnosis of breast cancer to the occurrence of bone-related events，assessed up to 100 months.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All eligible patients admitted to Zhejiang Cancer Hospital from January 1, 2021 to February 28, 2023 were included

You may qualify if:

• Age ≥18y;
• Advanced breast cancer is clearly diagnosed;
• Imaging or pathology confirmed at least 1 bone metastasis;
• No history of other malignant tumors at the time of initial diagnosis;
• The physical status score of Eastern Tumor Collaboration Group (ECOG) was ≤2 points;
• Complete clinical and follow-up data.

You may not qualify if:

• Patients with other malignant tumors;
• History of hyperthyroidism and hypothyroidism, abnormal parathyroid function;
• History of bone metabolic diseases.

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Zhejiang, China

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 23, 2025
• First Posted: March 13, 2025
• Study Start: January 1, 2021
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 13, 2025

Record last verified: 2025-02

Locations

CN (1)