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

Analysis of the Occurrence Time of Bone Metastasis and Disease Treatment Patterns in Patients with Breast Cancer Bone Metastasis: a Retrospective Study from China

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer Metastatic

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 Type: Observational
• Enrollment (Actual): 737

Contacts and Locations

Study Locations

• China
  • Zhejiang, China
    • Zhejiang Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with Clinical features of bone metastasis	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.	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	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	From the start of treatment with bone care drugs to 1 year
Patterns of bone metastasis in the center	The time of bone metastasis were included	rom the diagnosis of breast cancer to the occurrence of bone metastasis,assessed up to 100 months
Occurrence of bone-related events	Skeleton-relative Events (SREs) include pathological fractures, spinal cord compression, bone surgery, and radiation therapy	From the diagnosis of breast cancer to the occurrence of bone-related events，assessed up to 100 months.

Collaborators and Investigators

• Sponsor: Zhejiang Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): October 1, 2024
• Study Completion (Actual): December 1, 2024

Study Registration Dates

• First Submitted: February 23, 2025
• First Submitted That Met QC Criteria: March 12, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 12, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: IRB-2023-692

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No