A test in female patients with breast cancer to probably reduce side effects on blood cells by the planned chemotherapy and to collect data for medical research and drug development on the safety, possible benefits and distribution of an experimental drug called Myelo001 in comparison to a standard treatment.
- Conditions
- Chemotherapy-induced neutropenia (CIN)MedDRA version: 20.0Level: PTClassification code 10072806Term: Chemotherapy toxicity attenuationSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-003610-25-DE
- Lead Sponsor
- Myelo Therapeutics GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 130
Eligible patients must meet ALL of the following 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 CTX or adjuvant CTX (patient with primary wound healing ([R0])
3. Already selected for neoadjuvant or adjuvant standard of care poly-chemotherapy regimen containing anthracyclines in combination with cyclophosphamide (with or without follow-up treatment with taxanes) defined as EC standard regimen
4. Risk of CTX induced FN =20% according to ASCO guidelines (2015)
5. More than 5 days remaining before the planned initiation of the 1st CTX cycle (d1/c1) to allow initiation of IMP on d-5/c1
6. Performance status Grade 0-1 (ECOG)
7. Echocardiography: No contraindication for the scheduled CTX
8. Haematologic and chemistry thresholds at baseline:
• Absolute neutrophil count (ANC) =2,000 cells/ mm3 (=2.0 x 10^9/L)
• Platelet count =100,000/mm3 (=100 x 10^9/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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 110
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
A patient will be excluded from participation in the trial, if one or more of the following exclusion criteria are identified:
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) for the first CTX cycle
5. Currently on or scheduled for other immunostimulatory or hematopoietic active therapies (e.g.G-CSF, GM-CSF) for the first CTX cycle
6. Currently on or scheduled for primary prophylaxis with antibiotics for the first CTX cycle
7. History of bone marrow transplantation or stem cell transplant
8. Administration of another IMP / medical device within 30 days prior to screening. Participation in non-interventional, national or international cancer registries is allowed
9. Already confirmed HIV, 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method