Breast cancer treated by myelotoxic chemotherapy Cancer Malignant neoplasm of breast
Conditions
Interventions
Arm 1: XM02, 5 µg/kg body weight/day subcutaneously (s.c.)
Arm 2: Filgrastim, 5 µg/kg body weight/day s.c.
Arm 3: Placebo, 5 µg/kg body weight/day s.c.
The study drug/placebo was administered in e
Sponsors
BioGeneriX AG (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed and dated written informed consent 2. Age above or equal 18 years, both males and females 3. Breast cancer high risk stage II, or stage III or IV (classification according to American Joint Committee on Cancer [AJCC]) 4. Patients planned/eligible to receive treatment with docetaxel/doxorubicin as routine chemotherapy (CTX) for their breast cancer disease 5. CTX naïve 6. Eastern Cooperative Oncology Group (ECOG) performance status below or equal 2 7. Absolute neutrophil count (ANC) above or equal 1.5 x 10^9/L 8. Platelet count above or equal 100 x 10^9/L 9. Adequate cardiac function (including left ventricular ejection fraction above or equal 50% as assessed by echocardiography within 4 weeks prior to randomisation) 10. Adequate hepatic function i.e., alanine and aspartate aminotransferases (ALT/AST) <2.5 x upper limit of normal (ULN), alkaline phosphatase (AP) <5 x ULN, bilirubin <ULN 11. Adequate renal function, i.e., creatinine <1.5 x ULN
Exclusion criteria
Exclusion criteria: 1. Participation in a clinical trial within 30 days before randomisation 2. Previous exposure to filgrastim, pegfilgrastim or lenograstim 3. Known hypersensitivity to docetaxel 4. Underlying neuropathy of grade 2 or higher 5. Treatment with systemically active antibiotics within 72 hours before CTX 6. Treatment with lithium 7. Chronic use of oral corticosteroids 8. Prior radiation therapy within 4 weeks before randomisation 9. Prior bone marrow or stem cell transplantation 10. Prior malignancy within the previous 5 years other than basal cell or squamous cell carcinomas or in situ carcinoma of the cervix 11. Any illness or condition that in the opinion of the investigator could affect the safety of the patient or the evaluation of any study endpoint 12. Pregnant or nursing women were excluded. Women of child-bearing potential had to agree to use a chemical or barrier contraceptive during the treatment period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of severe neutropenia in cycle 1 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Secondary efficacy endpoints: 1.1. Incidence of observed febrile neutropenia (FN) (observed FN defined as body temperature of >38.5°C for more than 1 hour, measured axillary with a calibrated standard device, and ANC <0.5 x 10^9/L, both measured on the same day) and of protocol defined FN (intake of systemic antibiotics) by cycle and across all cycles 1.2. Duration of severe neutropenia in cycles 2 to 4 1.3. Depth of ANC nadir in cycles 1 to 4 1.4. Times to ANC recovery in cycles 1 to 4 1.5. Mortality 2. Safety endpoints, determined at the beginning and at the end of each chemotherapy cycle until day 85, antibody determination until day 180: 2.1. Adverse events (AEs) 2.3. Safety laboratory assessment 2.4. Physical examination 2.5. Injection site reactions 2.6. Vital signs 2.7. Eastern Cooperative Oncology Group (ECOG) performance 2.8. Immunogenicity (development of antibodies against study drug) Other: 3. Pharmacokinetics in a subset of patients | — |
Countries
Belarus, Brazil, Chile, Hungary, Lithuania, Poland, Romania, Russian Federation, Slovenia, South Africa
Outcome results
None listed