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

Completed

• Conditions: Breast Cancer Metastatic

• Registration Number: NCT06873997
• Lead Sponsor: Zhejiang Cancer Hospital

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.

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2024-10-01
• Study Completion: 2024-12-01
• Status Verified: 2025-02
• Study First Submitted: 2025-02-23
• Study First Submitted QC: 2025-03-12
• Last Update Submitted: 2025-03-12
• Study First Posted: 2025-03-13
• Last Update Posted: 2025-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 737

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

Exclusion is defined as meeting 1 of the following exclusion criteria:

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bone metastasis-free interval (BMFI) of breast cancer patients with bone metastasis	From the diagnosis of breast cancer to the occurrence of bone metastasis，assessed up to 100 months	Bone metastasis-free interval (BMFI) is the time between diagnosis of breast cancer and the onset of bone metastases

Secondary Outcome Measures

Name	Time	Method
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	CT value selection method: A professional physician manually selected a region of interest (ROI) for a single bone metastatic lesion, and recorded the mean value of CT value, which was expressed in Hounsfield units (HU). The ROI difference of the same bone metastasis before and after treatment was not more than ±10mm2
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	Clinical characteristics of patients with bone metastasis include age, menstrual status, body mass index (BMI), presence or non-presence of underlying disease, tumor location, primary tumor size, number of lymph node metastases, TNM stage, pathologic type, histological classification, vascular thrombus invasion, estrogen receptor (ER) status, progesterone receptor (PR) status, and other factors. Human epidermal growth factor receptor-2 (HER-2) expression, Ki-67 level, whether chemotherapy and radiotherapy, recurrence and metastasis time, recurrence and metastasis site.
Occurrence of bone-related events	From the diagnosis of breast cancer to the occurrence of bone-related events，assessed up to 100 months.	Skeleton-relative Events (SREs) include pathological fractures, spinal cord compression, bone surgery, and radiation therapy
Patterns of bone metastasis in the center	rom the diagnosis of breast cancer to the occurrence of bone metastasis,assessed up to 100 months	The time of bone metastasis were included

Trial Locations

Locations (1)

Zhejiang Cancer Hospital; 🇨🇳 Zhejiang, China