Pathological Fracture in Potentially Unstable Spinal Metastases of Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-15

Study Completion Date

2022-12-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to identify potential risk factors for and determine the rate of pathological fracture for patients which having spine metastases from breast cancer and be defined as potentially unstable (SINS 7-12) according to the Spinal Instability Neoplastic Score (SINS). The investigators' analysis will provide robust data about the development of spinal instability and help identify the optimal timing of local surgery treatment.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pilot Study of Bone Biopsy and Aspirate in Women With Metastatic Breast Cancer

NCT01975597

Metastatic Breast Cancer

TERMINATED

Risk Factors for Skeletal Related Events in Breast Cancer Patients Receiving Bisphosphonates for Bone Metastases

NCT01144481

Bone Metastases Breast Cancer

COMPLETED

PCI in Advanced Triple Negative Breast Cancer Patients Who Response to 1st Line Chemotherapy

NCT02448576

Breast Cancer Brain Metastasis

UNKNOWN NA

A Study for Dynamic Prediction Model of Breast Cancer Bone Metastases

NCT06544668

Breast Cancer Bone Metastases

NOT_YET_RECRUITING

Study in Patients With Breast Cancer Leptomeningeal Metastasis

NCT06638294

Leptomeningeal Metastasis of Breast Cancer

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Considering the concept of spinal instability remains important in the clinical decision-making process for patients with spine metastases, the Spine Oncology Study Group (SOSG) devised an 18-point SINS, which proved reliable and has been widely used in clinical practice. Scores of 0-6, 7-12, 13-18 are considered stable, potentially unstable, and unstable, respectively. Lesions with a low SINS (score 0-6) do not requires surgical interventions, whereas a high SINS (score 13-18) predicts the need for surgical stabilization to restore spinal stability. However, treatment strategy of intermediate SINS (score 7-12) lesions remains ambiguous owing to the uncertainty of spinal stability. With the duration of spinal metastases, some potentially unstable lesions turn to be stable while some turn to be unstable, and several factors such as tumor involvement for vertebral body, radiotherapy may account for different outcomes. Owing to the relatively weaker growth and invasion ability of breast cancer cells compared to other solid tumors such as lung cancer and liver cancer, patients with breast cancer and spinal metastases have longer life expectancy. Reasonable and prompt local surgical intervention to restore spinal stability can achieve pain relief and better quality of life effectively. Moreover, most spinal metastases from breast cancer show lytic or mixed lytic-blastic bone lesions, which exacerbates the spinal stability and results in pathological fracture. Thus, investigators focus on patients which having spinal metastases from breast cancer and an intermediate SINS (score 7-12) to explore the rate of pathological fracture and relevant risk factors. This study will help spine surgeon to identify who could benefit from a prophylactic stabilization procedure with high risk of pathological fracture and when is the best timing of surgery.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Spinal Metastases Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Spinal metastases of breast cancer

Patients with potentially unstable spinal metastases of breast cancer

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age 18-65 years, female
* Had a histological confirmation of breast cancer, including all pathological types
* Had a histological or radiological confirmation of spinal metastases from breast cancer
* SINS 7-12

Exclusion Criteria

* Prior prophylactic stabilization surgery to the spine at current level of interest
* Patients with other malignancies except breast cancer
* Misdiagnosis of spinal metastases from breast cancer confirmed by pathological examination
* Patients without undergoing follow-up on schedule
* Withdraw from the study for any reason

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No