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 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.
6. Willingness to undergo lumbar puncture at diagnosis of CNS metastases unless medical
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
1. Pregnant and/or lactating women.
2. Previous or current malignancies of other histologies within the last 5 years, with
the exception of in situ carcinoma of the cervix, and adequately treated basal cell or
squamous cell carcinoma of the skin.
3. 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
4. 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.