Leptomeningeal Metastasis of Breast CancerBioLeptNCT06638294
Study in Patients With Breast Cancer Leptomeningeal Metastasis
An observational study of Leptomeningeal Metastasis of Breast Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 2 sites in United States.
Trial summary
Traditional clinical trials in patients with breast cancer leptomeningeal disease (LMD) are challenging as patients often have a rapidly progressive course and prognosis is poor, making meeting standard eligibility difficult. Furthermore, there is limited information about the biology of LMD. Read more about this study
- Who is it for?
- Ages 18 weeks and older
- Conditions the study is for
- Leptomeningeal Metastasis of Breast Cancer
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Nov 2024to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 weeks and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This is a prospective translational observational study for patients with breast cancer leptomeningeal disease (LMD).
Who may be able to join
- Male or female, aged 18 or older
- History of breast cancer (any subtype)
- Suspected breast cancer-related leptomeningeal metastasis (i.e., by clinical signs or symptoms (i.e., peri-oral dysesthesia, unexplained new neurological symptoms in the absence of brain metastasis), radiographic, or by cerebrospinal fluid analysis), whereby patient will be treated along an leptomeningeal disease paradigm.
- Previous central nervous system metastasis (including leptomeningeal disease or brain metastasis) is eligible.
- Eastern Cooperative Oncology Group (ECOG) score of ≤3 or Karnofsky performance status ≥60.
Who cannot join
- Suspected central nervous system recurrence of hematologic malignancy, lymphoma or other solid tumor
- Not eligible for treatment of leptomeningeal disease.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21287
Hopkins Breast Trials, 410-614-1361, HopkinsBreastTrials@jhmi.edu
Cesar A Santa-Maria, M.D.
- Not yet recruiting
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016
Azka Tariq, 202-660-5712, atariq6@jhmi.edu
Aliya Lalji, 202-243-2294, alalji1@jhmi.edu
About this study
Official title: A Translational Observational Biorepository and Management Study in Patients With Breast Cancer Leptomeningeal Metastasis: The BioLept Study
Traditional clinical trials in patients with breast cancer leptomeningeal disease (LMD) are challenging as patients often have a rapidly progressive course and prognosis is poor, making meeting standard eligibility difficult. Furthermore, there is limited information about the biology of LMD. The investigators thus propose a study that is as inclusive as possible, which will allow the investigators to collect biospecimens and clinical outcomes to learn more about LMD biology, but still potentially provide benefit for patients, by providing patients rapid diagnostics and multi-disciplinary treatment recommendations.
Read the detailed description
This is a prospective translational observational study for patients with breast cancer leptomeningeal disease (LMD). LMD is notoriously difficult to treat, and prognosis is generally very poor, with most patients typically succumbing to the disease within a few months of its diagnosis. Conducting clinical trials is challenging for these reasons, and there are limited data regarding biological processes of LMD. The overarching goal of this study is to be as inclusive as possible to optimize and learn from patients with LMD. The investigators propose a prospective observational study to establish (1) a translational collection protocol to comprehensively collect tissue, blood, and CNS samples, and (2) a therapeutic management program utilizing the Johns Hopkins Molecular Tumor Board, to provide multi-disciplinary treatment recommendations in a timely manner, and (3) collect outcome data that can be correlated with biomarkers.
- Keywords
- breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with breast cancer leptomeningeal disease (LMD) | Participation involves allowing access to participant medical records including the genetic information of the tumor, undergoing standard-of-care work up as indicated (this may include MRI of brain or spine, spinal tap, etc.), providing a cerebrospinal (CSF) sample (less than 2 tablespoons), blood sample (about 4 tablespoons) at baseline and possibly again after month, and answering online questionnaires monthly. Johns Hopkins Molecular Tumor Board will review clinical and genetic information and provide treatment recommendations. CSF and blood will be collected at baseline no matter what treatment is recommended. If possible, collect CSF and blood again after one month. Additional blood and CSF sampling may also be obtained if/when therapy changes. The oncologist will ultimately decide if participant will proceed with the recommend treatment or not. Health information and questionnaires are obtained to assess how participants are doing on therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients who achieve goal time to treatment recommendation
Rapid molecular tumor board (MTB) evaluation. The investigators will measure the percentage of patients who achieve the following the goal time to treatment recommendation. The investigators goal time to treatment recommendation will be ≤7 days from enrollment, and the investigators goal time to treatment initiation ≤14 days from enrollment.
There is no set goal in terms of percentage of patients achieving set timeframes as there will be a significant variability. The investigators hope to continuously refine this process to meet these ideal timeframes. The investigators will report the investigators' ability to achieve these timeframes in order to evaluate the feasibility of rapid molecular tumor board (MTB) evaluation and time to treatment in patients with breast cancer leptomeningeal disease (LMD)..
Measured: 2 years
Secondary outcomes (2)
Correlation of patient reported outcomes and biomarkers
The investigators will assess patient reported outcomes (PROs) using the Patient-Reported Outcomes Measurement Information System Global-10 (PROMIS Global-10) and select questions from the Functional Assessment of Cancer Therapy - Central nervous System (FACT-CNS) and Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire. The investigators will describe development of central nervous systems and clinical deterioration, and correlate with patient reported outcomes and biomarkers including Germline testing and Tumor Next Generation Sequencing.
Measured: 2 years
Correlation of molecular features of cerebrospinal fluid and cerebrospinal fluid biomarkers
Molecular features of cerebrospinal fluid (CSF) including circulating tumor cell (CTCs) and cell-free tumor DNA (ctDNA). Cerebrospinal fluid biomarkers will be described and correlated with standard CSF assessments including cytology and cell count, radiographic assessments, and clinical outcomes, and correlate these with standard CSF and radiographic assessments, and patient outcomes.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start25 Nov 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leptomeningeal Metastasis of Breast CancerStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Avon Foundation
- Responsible party
- Sponsor
- Investigators
- Cesar Santa-Maria, MD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06638294
- Sponsor's protocol ID
- J2323
- Other IDs
- IRB00371039
- Acronym
- BioLept
- Status last verified
- Nov 2025
- First submitted
- 9 Oct 2024
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Translational Observational Biorepository and Management Study in Patients With Breast Cancer Leptomeningeal Metastasis: The BioLept Study
- ClinicalTrials.gov ID
- NCT06638294
- Acronym / sponsor ID
- BioLept / J2323
- Keywords
- breast cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Avon Foundation
- Study start
- 25 Nov 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 15 Oct 2024 (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.
Traditional clinical trials in patients with breast cancer leptomeningeal disease (LMD) are challenging as patients often have a rapidly progressive course and prognosis is poor, making meeting standard eligibility difficult. Furthermore, there is limited information about the biology of LMD. The investigators thus propose a study that is as inclusive as possible, which will allow the investigators to collect biospecimens and clinical outcomes to learn more about LMD biology, but still potentially provide benefit for patients, by providing patients rapid diagnostics and multi-disciplinary treatment recommendations.
Detailed description
This is a prospective translational observational study for patients with breast cancer leptomeningeal disease (LMD). LMD is notoriously difficult to treat, and prognosis is generally very poor, with most patients typically succumbing to the disease within a few months of its diagnosis. Conducting clinical trials is challenging for these reasons, and there are limited data regarding biological processes of LMD. The overarching goal of this study is to be as inclusive as possible to optimize and learn from patients with LMD. The investigators propose a prospective observational study to establish (1) a translational collection protocol to comprehensively collect tissue, blood, and CNS samples, and (2) a therapeutic management program utilizing the Johns Hopkins Molecular Tumor Board, to provide multi-disciplinary treatment recommendations in a timely manner, and (3) collect outcome data that can be correlated with biomarkers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with breast cancer leptomeningeal disease (LMD) | – | –Participation involves allowing access to participant medical records including the genetic information of the tumor, undergoing standard-of-care work up as indicated (this may include MRI of brain or spine, spinal tap, etc.), providing a cerebrospinal (CSF) sample (less than 2 tablespoons), blood sample (about 4 tablespoons) at baseline and possibly again after month, and answering online questionnaires monthly. Johns Hopkins Molecular Tumor Board will review clinical and genetic information and provide treatment recommendations. CSF and blood will be collected at baseline no matter what treatment is recommended. If possible, collect CSF and blood again after one month. Additional blood and CSF sampling may also be obtained if/when therapy changes. The oncologist will ultimately decide if participant will proceed with the recommend treatment or not. Health information and questionnaires are obtained to assess how participants are doing on therapy. |
Who may qualify
- Ages
- 18 weeks and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This is a prospective translational observational study for patients with breast cancer leptomeningeal disease (LMD).
Key inclusion criteria (5 listed)
- Male or female, aged 18 or older
- History of breast cancer (any subtype)
- Suspected breast cancer-related leptomeningeal metastasis (i.e., by clinical signs or symptoms (i.e., peri-oral dysesthesia, unexplained new neurological symptoms in the absence of brain metastasis), radiographic, or by cerebrospinal fluid analysis), whereby patient will be treated along an leptomeningeal disease paradigm.
- Previous central nervous system metastasis (including leptomeningeal disease or brain metastasis) is eligible.
- Eastern Cooperative Oncology Group (ECOG) score of ≤3 or Karnofsky performance status ≥60.
Key exclusion criteria (2 listed)
- Suspected central nervous system recurrence of hematologic malignancy, lymphoma or other solid tumor
- Not eligible for treatment of leptomeningeal disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of patients who achieve goal time to treatment recommendation
Time frame: 2 years
Rapid molecular tumor board (MTB) evaluation. The investigators will measure the percentage of patients who achieve the following the goal time to treatment recommendation. The investigators goal time to treatment recommendation will be ≤7 days from enrollment, and the investigators goal time to treatment initiation ≤14 days from enrollment. There is no set goal in terms of percentage of patients achieving set timeframes as there will be a significant variability. The investigators hope to continuously refine this process to meet these ideal timeframes. The investigators will report the investigators' ability to achieve these timeframes in order to evaluate the feasibility of rapid molecular tumor board (MTB) evaluation and time to treatment in patients with breast cancer leptomeningeal disease (LMD)..
2 secondary outcomes
Correlation of patient reported outcomes and biomarkers
Time frame: 2 years
Correlation of molecular features of cerebrospinal fluid and cerebrospinal fluid biomarkers
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
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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.
Cesar Santa-Maria, MD principal investigator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leptomeningeal Metastasis of Breast Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 2 sites in United States.
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 5 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hopkins Breast Trials (410-614-1361, HopkinsBreastTrials@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients who achieve goal time to treatment recommendation (time frame: 2 years). 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 28 Nov 2025.