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NCT Number: NCT06873997

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhejiang Cancer Hospital

Zhejiang, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

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

Treatment and study plan

Primary outcomes

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

    Time frame: 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 outcomes

  1. Number of participants with Clinical features of bone metastasis

    Time frame: 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.

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

    Time frame: 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

  3. Patterns of bone metastasis in the center

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

    The time of bone metastasis were included

  4. Occurrence of bone-related events

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Zhejiang Cancer Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Mar 13, 2025
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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