Clinical trial NCT02692742 (phase 2, status: completed)
Conditions: chemotherapy-induced neutropenia, myelosuppression, breast cancer
ICD codes: D61.810, C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: myelo001, placebo
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          1. Female patient of any racial origin having fulfilled her 18th birthday on Visit 1
             (Screening)

          2. Histologically confirmed invasive breast cancer scheduled for neoadjuvant or adjuvant
             chemotherapy (patient with primary wound healing ([R0])

          3. Already selected for neoadjuvant or adjuvant standard of care EC regimen (Epirubicin
             90 mg/m2 BSA (body surface area) + Cyclophosphamide 600 mg/m2 BSA q21d (every 21
             days)) (with or without treatment with taxanes afterwards)

          4. Risk of chemotherapy-induced Febrile Neutropenia ≤20% according to ASCO Guidelines
             (2015)

          5. More than 5 days remaining before the planned initiation of the 1st chemotherapy cycle

          6. Performance status Grade 0-1 (ECOG)

          7. Echocardiography: No contraindication for the scheduled chemotherapy

          8. Haematologic, laboratory and chemistry thresholds at baseline:

               -  Absolute neutrophil count (ANC) ≥2,000 cells/ mm3 (≥2.0 x 10/L)

               -  Platelet count ≥100,000/mm3 (≥100 x 10exp9/L)

               -  Haemoglobin ≥10 g/dL

               -  Total bilirubin <1.5 x, AST, ALT <2.5 x upper limit of normal (ULN)

               -  Serum creatinine <2.0 mg/dL

          9. Able to read, understand and willing to sign the informed consent form

         10. Able to undergo the investigations and to follow the Visit schedule

        Exclusion Criteria:

          1. Suspected allergy to Myelo001 or its excipients

          2. Prior chemotherapy

          3. Prior or concomitant treatment with radiotherapy

          4. Currently on or scheduled for other immunomodulatory or immunosuppressive therapies
             (e.g. TNF inhibitors) during the first chemotherapy cycle

          5. Currently on or scheduled for other immunostimulatory or hematopoietic active
             therapies (e.g.G-CSF, GM-CSF)

          6. Currently on or scheduled for primary prophylaxis with antibiotics in the first
             chemotherapy cycle

          7. History of bone marrow transplantation or stem cell transplant

          8. Administration of another investigational medicinal product / medical device within 30
             days prior to screening. Participation in non-interventional, national or
             international cancer registries is allowed.

          9. Already confirmed HIV, hepatitis B or C virus (HBV or HCV) infection

         10. History of somatic disease/condition that may interfere with the objectives of the
             study

         11. Any other medical disease or clinical laboratory parameter outside the normal range
             and of clinical significance according to the investigator

         12. Serious uncontrolled comorbidities

         13. Pregnant or breast-feeding subject

         14. Woman considered to be of childbearing potential who do not use highly effective birth
             control methods during the study.