Clinical trial NCT06873997: Real World Study of Bone Metastases in Patients with Advanced Breast Cancer
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer Metastatic
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2025-03-13
Enrollment: 737
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Bone metastasis-free interval (BMFI) of breast cancer patients with bone metastasis
timeFrame: From the diagnosis of breast cancer to the occurrence of bone metastasis，assessed up to 100 months
Secondary outcomes:
measure: Number of participants with Clinical features of bone metastasis
timeFrame: From the diagnosis of breast cancer to the conclusion of the study period，assessed up to 100 months
measure: Changes of CT values of bone lesions before and after treatment with bone protective drugs
timeFrame: From the start of treatment with bone care drugs to 1 year
measure: Patterns of bone metastasis in the center
timeFrame: rom the diagnosis of breast cancer to the occurrence of bone metastasis,assessed up to 100 months
measure: Occurrence of bone-related events
timeFrame: From the diagnosis of breast cancer to the occurrence of bone-related events，assessed up to 100 months.
Other outcomes:
Locations:
city: Zhejiang
country: China
facility: Zhejiang Cancer Hospital
Study officials:
References: