Clinical trial · Observational
Pathological Fracture in Potentially Unstable Spinal Metastases of Breast Cancer
A Pilot Study of Pathological Fracture Progression and Related Risk Factors for Patients With Potentially Unstable Spinal Metastases of Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Spinal Metastases | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Spinal metastases of breast cancer
- description
- Patients with potentially unstable spinal metastases of breast cancer
Primary outcomes (1)
- measure
- Rate of the pathological fracture of spine
- timeFrame
- First diagnosis of spinal metastases, every 3 months in the first year after diagnosis, every 6 months after one year after diagnosis. Up to 2 years
- description
- Pathological fracture will be detected using Magnetic Resonance Imaging (MRI)
Secondary outcomes (5)
- measure
- Quality of life outcomes measured by EORTC QLQ-C30 questionnaire
- timeFrame
- First diagnosis of spinal metastases, every 3 months in the first year after diagnosis, every 6 months after one year after diagnosis. Up to 2 years
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available