Leptomeningeal Metastasis in Breast CancerNCT07386886
Development of a Novel Graded Prognostic Assessment (BC-LGPA) Model for Breast Cancer Leptomeningeal Metastasis
An observational study of Leptomeningeal Metastasis in Breast Cancer, run by Jian Zhang,MD.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Leptomeningeal Metastasis in Breast Cancer
- What is being tested?
- systematic therapy
- How many people
- 403 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2013to 26 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- patients with BCLM
Who cannot join
- patients with other BC CNS metastasis
About this study
Official title: 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.
- Being tested
- systematic therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
systematic therapyDrug
Patients with BCLM receive systematic therapy，IT and radiation.
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Time from date of randomization to the date of death from any cause
Measured: Up to approximately 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start30 Nov 2013
- Primary completion30 Nov 2025
- Study completion26 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leptomeningeal Metastasis in Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 403 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jian Zhang,MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jian Zhang,MD, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07386886
- Sponsor's protocol ID
- 260126
- Status last verified
- Feb 2026
- First submitted
- 26 Jan 2026
- Last updated
- 4 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Cohort Study of Leptomeningeal Metastasis in Breast Cancer: Clinical Characterization and Development of a Novel Graded Prognostic Assessment (BC-LGPA) Model
- ClinicalTrials.gov ID
- NCT07386886
- Acronym / sponsor ID
- 260126
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 403 participants (actual)
- Lead sponsor
- Jian Zhang,MDUniversity, hospital or other
- Study start
- 30 Nov 2013 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 26 Jan 2026 (actual)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- patients with BCLM
Key exclusion criteria (1 listed)
- patients with other BC CNS metastasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| systematic therapyPatients with BCLM receive systematic therapy，IT and radiation. | Drug | – |
Primary outcome
Overall survival
Time frame: Up to approximately 30 months
Time from date of randomization to the date of death from any cause
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Leptomeningeal Metastasis in Breast Cancer, run by Jian Zhang,MD.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: Up to approximately 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.