NCT07386886

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
403

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2013

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 30, 2013

Completed
12 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 26, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 4, 2026

Completed
Last Updated

February 4, 2026

Status Verified

February 1, 2026

Enrollment Period

12 years

First QC Date

January 26, 2026

Last Update Submit

February 3, 2026

Conditions

Leptomeningeal Metastasis in Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    Time from date of randomization to the date of death from any cause

    Up to approximately 30 months

Interventions

systematic therapyDRUG

Patients with BCLM receive systematic therapy，IT and radiation.

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • patients with BCLM

You may not qualify if:

  • patients with other BC CNS metastasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of Phase I clinical Research ward

Study Record Dates

First Submitted

January 26, 2026

First Posted

February 4, 2026

Study Start

November 30, 2013

Primary Completion

November 30, 2025

Study Completion

January 26, 2026

Last Updated

February 4, 2026

Record last verified: 2026-02