- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07386886
Development of a Novel Graded Prognostic Assessment (BC-LGPA) Model for Breast Cancer Leptomeningeal Metastasis
February 3, 2026 updated by: Jian Zhang,MD
A Multicenter Cohort Study of Leptomeningeal Metastasis in Breast Cancer: Clinical Characterization and Development of a Novel Graded Prognostic Assessment (BC-LGPA) Model
The investigators conducted a large, multicenter retrospective study of patients with breast cancer leptomeningeal metastasis (BCLM), constituting one of the largest and most comprehensively curated cohorts to date.
Data from 403 patients diagnosed between November 2013 and November 2025 were collected from three major academic centers.
Detailed clinical, pathological, diagnostic, and treatment data were analyzed.
Overall survival (OS) was evaluated, and independent prognostic factors were identified via Cox regression.
A novel Breast Cancer Leptomeningeal Graded Prognostic Assessment (BC-LGPA) model was developed and validated for risk stratification.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
403
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
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
The investigators conducted a large, multicenter retrospective study of patients with breast cancer leptomeningeal metastasis (BCLM), constituting one of the largest and most comprehensively curated cohorts to date.
Data from 403 patients diagnosed between November 2013 and November 2025 were collected from three major academic centers.
Description
Inclusion Criteria:
- patients with BCLM
Exclusion Criteria:
- patients with other BC CNS metastasis
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
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall survival
Time Frame: Up to approximately 30 months
|
Time from date of randomization to the date of death from any cause
|
Up to approximately 30 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
November 30, 2013
Primary Completion (Actual)
November 30, 2025
Study Completion (Actual)
January 26, 2026
Study Registration Dates
First Submitted
January 26, 2026
First Submitted That Met QC Criteria
February 3, 2026
First Posted (Actual)
February 4, 2026
Study Record Updates
Last Update Posted (Actual)
February 4, 2026
Last Update Submitted That Met QC Criteria
February 3, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- 260126
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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.