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

Inclusion Criteria

• •1. Age ≥ 18 years old
• •2. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
• •3. Female or Male
• •4. 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
• •5. Availability of either primary and/or non-CNS metastatic archival tumour tissue is mandatory for inclusion.
• •6. Willingness to undergo lumbar puncture at diagnosis of CNS metastases unless medical contra-indications
• •7. Predicted life expectancy \> 3 months.
• •8. Women of childbearing potential must have a negative urine pregnancy test done within 28 days prior to enrolment
• •9. Effective contraception is in place for women of childbearing potential
• •10. Completion of all necessary screening procedures within 28 days prior to enrolment.
• •11. Signed Informed Consent form (ICF) obtained prior to any study related procedure.
• •Inclusion criterion applicable to FRANCE only
• •12. Affiliated to the French Social Security System