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

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.

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