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NCT Number: NCT04109131

A Brain Metastases Research Platform to Tackle the Challenge of CNS Metastases in Solid Tumours

Despite some encouraging data, systemic treatment of CNS metastases from solid tumors remains experimental.

Better knowledge on the evolving epidemiology and biology of BM are key elements for the development of new treatment strategies and identification of promising therapeutic targets for new compounds. Further biological findings may help to better understand the heterogeneity between the primary tumor and the CNS metastases and to identify new targets for therapy thus improving patients' outcome.

In this context, the Oncodistinct network and the Jules Bordet institute propose to build a multidisciplinary Brain Metastases Clinical Research Platform called BrainStorm. The BrainStorm program will focus on patients with newly diagnosed non-CNS metastatic solid tumors with high risk of developing CNS metastases and will allow building a large clinico pathological database for CNS metastases including ctDNA analyzes from CSF samples. Substudies will be proposed at each time-period with the final objective to develop innovative treatment approaches and strategies.

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Key information

Conditions

CNS Metastases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Jules Bordet, Anderlecht, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years old
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  • Female or Male
  • Eligible for part A: Subjects (from cohorts 1 to 5) with newly diagnosed or up to 24 months from diagnosis of non-CNS metastases. Enrolment of exceptional cases surpassing 24 months from diagnosis will be allowed for up to 20% of subjects enrolled with HER2+ BC (cohort 2) and NSCLC harbouring driver mutations (cohort 3).

Eligible for part B: Subjects (from cohorts 1 to 7) presenting with a first CNS event and not yet enrolled in the program

Seven cohorts of subjects are defined in this prospective multicenter study:

  • Cohort 1: Triple negative breast cancer (TNBC)
  • Cohort 2: HER 2 positive breast cancer (HER2+ BC)
  • Cohort 3: Non-small cell lung cancer (NSCLC)
  • Cohort 4: Small cell lung cancer (SCLC)
  • Cohort 5: Melanoma
  • Cohort 6: Other solid tumours (apart from the above mentioned subtypes
  • Cohort 7: Radiologically or cytologically confirmed leptomeningeal carcinomatosis
  • Availability of either primary and/or non-CNS metastatic archival tumour tissue is mandatory for inclusion.
  • Willingness to undergo lumbar puncture at diagnosis of CNS metastases unless medical contra-indications
  • Predicted life expectancy > 3 months.
  • Women of childbearing potential must have a negative urine pregnancy test done within 28 days prior to enrolment
  • Effective contraception is in place for women of childbearing potential
  • Completion of all necessary screening procedures within 28 days prior to enrolment.
  • Signed Informed Consent form (ICF) obtained prior to any study related procedure.

Inclusion criterion applicable to FRANCE only

  • Affiliated to the French Social Security System

Exclusion criteria

  • Pregnant and/or lactating women.
  • Previous or current malignancies of other histologies within the last 2 years, with the exception of in situ carcinoma of the cervix, and adequately treated basal cell or squamous cell carcinoma of the skin.
  • Subject with a significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the principal investigator's opinion, may interfere with completion of the study.

Exclusion criterion applicable to FRANCE only

  • Vulnerable persons according to the article L.1121-6 of the Public Health Code, adults who are the subject of a measure of legal protection or unable to express their consent according to article L.1121-8 of the Public Health Code.

Treatment and study plan

Samples collection: Plasma

Other

At baseline

Part A:

  • TNBC/ HER2+ BC: once a year
  • NSCLC/SCLC: every 4 months
  • Melanoma: every 6 months

Part B:

o As close as possible to the diagnosis of CNS metastases and no later than 6 weeks after diagnosis

Part C:

o Every 3 months (+/- 1 month)

Other names: Blood for plasma preparation

Samples collection: CSF

Other

Part B: Mandatory CSF sampling at CNS diagnosis when clinically possible unless medically contra-indicated - As close as possible to the diagnosis of CNS metastases and no later than 6 weeks after diagnosis Part C: Additional CSF sampling in case CSF sampling is performed for routine clinical practice

Other names: CSF sample

Samples collection: Non-CNS Metastatic Tumour Tissue

Other

Part B: Highly recommended non-CNS metastatic tumour tissue collection (1FFPE and 1 FT) at CNS metastases diagnosis (Part B) (NB: Bone lesions are excluded) - As close as possible to the diagnosis of CNS metastases and no later than 6 weeks after diagnosis

Other names: Non-CNS Metastatic Tumour Tissue collection

Brain MRI

Other

Part A:

  • Brain MRI at inclusion is allowed within 45 days before enrolment
  • Brain MRI pre-CNS diagnosis (Part A) : HER2 BC/TNBC: once a year; NSCLC/SCLC: every 4 months; Melanoma: every 6 months (+/- 1 month)

Part B:

o As close as possible to the diagnosis of CNS metastases and no later than 6 weeks after diagnosis

Part C:

o Brain MRI post-CNS diagnosis (Part C): every 3 months (+/- 1 month window)

Samples collection: Serum

Other

At baseline

Part A:

  • TNBC/ HER2+ BC: once a year
  • NSCLC/SCLC: every 4 months
  • Melanoma: every 6 months

Part B:

o As close as possible to the diagnosis of CNS metastases and no later than 6 weeks after diagnosis for cohorts 1-5.

Other names: Blood for serum preparation

Primary outcomes

  1. Better understanding of the epidemiology of CNS metastases from solid tumours

    Time frame: through study completion, approximately 96 months

    To collect data regarding the epidemiology of CNS metastases from solid tumours and identify risk factors for CNS metastases development, including:

    • Time to the first CNS event
    • Time to the second CNS after first treatment and subsequent CNS events

  2. Better understanding of the epidemiology of CNS metastases from solid tumours

    Time frame: through study completion, approximately 96 months

    To collect data regarding the epidemiology of CNS metastases from solid tumours and identify risk factors for CNS metastases development, including::

    • Time to whole brain radiotherapy

  3. Better understanding of the epidemiology of CNS metastases from solid tumours

    Time frame: through study completion, approximately 96 months

    To collect data regarding the epidemiology of CNS metastases from solid tumours and identify risk factors for CNS metastases development, including:

    • Overall survival

  4. Better understand the biology of CNS metastases (brain and leptomeningeal carcinomatosis) using CSF-ctDNA as a surrogate endpoint for CNS tumour tissue DNA.

    Time frame: through study completion, approximately 96 months

    To collect data regarding the biology of CNS metastases by investigating on:

    • Presence of CSF-ctDNA at diagnosis of CNS metastases

  5. Better understand the biology of CNS metastases (brain and leptomeningeal carcinomatosis) using CSF-ctDNA as a surrogate endpoint for CNS tumour tissue DNA.

    Time frame: through study completion, approximately 96 months

    To collect data regarding the biology of CNS metastases by investigating on:

    • Presence of plasma ctDNA at diagnosis of CNS metastases

  6. Better understand the biology of CNS metastases (brain and leptomeningeal carcinomatosis) using CSF-ctDNA as a surrogate endpoint for CNS tumour tissue DNA.

    Time frame: through study completion, approximately 96 months

    • quantification of plasma ctDNA and CSF-ctDNA using deep targeted NGS
    • deep targeted next-generation sequencing (NGS) on DNA samples from primary or non-CNS metastases as well as germline DNA samples and CNS metastases if surgery

  7. Better understand the biology of CNS metastases (brain and leptomeningeal carcinomatosis) using CSF-ctDNA as a surrogate endpoint for CNS tumour tissue DNA.

    Time frame: through study completion, approximately 96 months

    • A set of 1-3 point mutations (single nucleotide variants) will be selected for each subject based on the above analyses for the identification and quantification of plasma ctDNA and CSF-ctDNA using deep targeted NGS

  8. Better understand the biology of CNS metastases (brain and leptomeningeal carcinomatosis) using CSF-ctDNA as a surrogate endpoint for CNS tumour tissue DNA.

    Time frame: through study completion, approximately 96 months

    • Standard analyses cytology and biochemistry analyses

  9. Better understand the biology of CNS metastases (brain and leptomeningeal carcinomatosis) using CSF-ctDNA as a surrogate endpoint for CNS tumour tissue DNA.

    Time frame: through study completion, approximately 96 months

    • Quantitative measurement of serum neuron-specific enolase

Other outcomes

  1. Better understand the predictive value of NSE for the development of CNS metastases on subjects with newly diagnosed non-CNS metastatic solid tumours with high risk of developing CNS metastases.

    Time frame: through study completion, approximately 96 months

    To collect data regarding the biology of CNS metastases by investigating on :

    • Time to the first CNS event
    • Time to the second CNS event
    • Time to whole brain radiotherapy (WBR)
    • Time from the date of diagnosis of the first CNS event and the time of death by any cause

  2. Better understand the predictive value of NSE for the development of CNS metastases on subjects with newly diagnosed non-CNS metastatic solid tumours with high risk of developing CNS metastases.

    Time frame: through study completion, approximately 96 months

    Levels of neuron specific enolase in blood

  3. Better understand the predictive value of NSE for the development of CNS metastases on subjects with newly diagnosed non-CNS metastatic solid tumours with high risk of developing CNS metastases.

    Time frame: through study completion, approximately 96 months

    Deep targeted next-generation sequencing (NGS) on DNA samples from primary or non CNS metastases as well as germline DNA samples and CNS metastases if surgery. A set of 1-3 point mutations (single nucleotide variants) will be selected for each subject based on the above analyses for the identification and quantification of plasma ctDNA and CSF-ctDNA using deep targeted NGS. Subsequently targeted gene sequencing will be performed on DNA samples from CSF and plasma in case of at least 5% tumour mutant allele frequency (MAF) and CNS metastases in case of surgery.

Study contacts

Contact information is provided by the study sponsor or research team.

Diane Delaroche

CONTACT

[email protected]

+322541 ext. 7358

Nuria Kotecki

CONTACT

[email protected]

+322541 ext. 7366

Sponsors and collaborators

Lead sponsor

Jules Bordet Institute

Other

Collaborators

  • Bristol-Myers Squibb
  • Fondation Cancer, Belgique
  • Fondation Cancer, Luxembourg
  • Les Amis

Registry information

Official study title

A Brain Metastases Research Platform to Tackle the Challenge of CNS Metastases in Solid Tumours - BrainStorm Program

Acronym: BrainStorm

Important dates

Study start
2020
Primary completion
2028
Study completion
2029
First posted
Sep 30, 2019
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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