A Study for Dynamic Prediction Model of Breast Cancer Bone Metastases

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Not yet enrolling

Conditions: Breast Cancer; Bone Metastases

Treatments: Other: Breast cancer patients without bone metastasis; Other: Breast cancer patients with bone metastasis

Study type: Observational

Funder types: Other

Identifiers

NCT06544668

NCC4673

Details and patient eligibility

About

The purpose of this study is to identify the risk factors of bone metastasis in breast cancer patients so as to develop a dynamic prediction model using real world clinical data. The multicenter data will be retrospectively collected, and the clinical characteristics related to bone metastasis will be analyzed.

Full description

Breast cancer is the most common malignant tumor in women worldwide and bones are the most common sites of metastases in breast cancer patients(~70%). Bone metastasis often leads to skeletal-related events (SREs) ,which may not only reduce the quality of life in patients, but also affect the long-term survival. Therefore, early detection and early intervention of bone metastasis are particularly important for breast cancer patients.

Enrollment: 3,500 estimated patients

Sex: Female

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients diagnosed with breast cancer by histopathology;
2. Age between 20 and 70 years old;
3. The first diagnosis time is between 2010 and 2020;
4. Complete diagnosis and treatment information, including basic information, breast cancer diagnosis, surgery, recurrence diagnosis data (including the diagnosis of the metastasis sites), anti-tumor treatment data, bone health and bone metastasis-related diagnosis and treatment data, etc.;
5. Sufficient available follow-up information.

Exclusion criteria

1. Missing important basic information (including initial and recurrent pathology, stage, pathological grade and time, surgery time, and drug treatment);
2. With distant metastasis at the initial diagnosis;
3. Patients with autoimmune diseases or aggressive viral infections (such as HIV or hepatitis);
4. Other malignant tumors;
5. Unclear information about distant metastasis.

Trial design

3,500 participants in 2 patient groups

Breast cancer patients with bone metastasis

Treatment:

Other: Breast cancer patients with bone metastasis

Breast cancer patients without bone metastasis

Treatment:

Other: Breast cancer patients without bone metastasis