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

March 12, 2025 updated by: Wang Xiaojia, Zhejiang Cancer Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
737

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Zhejiang, China
        • Zhejiang Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
From the diagnosis of breast cancer to the occurrence of bone metastasis，assessed up to 100 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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
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
From the start of treatment with bone care drugs to 1 year
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
rom the diagnosis of breast cancer to the occurrence of bone metastasis,assessed up to 100 months
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
From the diagnosis of breast cancer to the occurrence of bone-related events，assessed up to 100 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zhejiang Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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