Breast cancer Cancer Malignant neoplasm of breast
Conditions
Interventions
Participants will be randomly allocated to the following two arms:
1. Neulasta®, 6 mg, administered subcutaneously once per chemotherapy cycle
2. XM22 administered subcutaneously once per chemotherap
Sponsors
BioGeneriX AG (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men and women aged >= 18 years 2. Signed and dated written informed consent 3. Breast cancer high risk stage II, or stage III or IV 4. Patients planned/eligible to receive treatment with docetaxel/doxorubicin as routine chemotherapy for their breast cancer disease 5. Chemotherapy-naïve 6. Eastern Cooperative Oncology Group (ECOG) performance status = 1.5 x 10^9/L 8. Platelet count >= 100 x 10^9/L 9. Adequate cardiac function (including left ventricular ejection fraction >= 50% as assessed by echocardiography or equivalent method within 4 weeks prior to randomisation) 10. Adequate hepatic function, i.e., alanine aminotransferase (ALT)/aspartate transaminase (AST) <2.5 x upper limit of normal (ULN), alkaline phosphatase <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, lenograstim, or other granulocyte-colony stimulating factors (G-CSFs) in clinical development 3. Known hypersensitivity to docetaxel 4. Underlying neuropathy of grade 2 or higher 5. Treatment with systemically active antibiotics within 72 hours before chemotherapy 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 may affect the safety of the patient or the evaluation of any study endpoint 12. Pregnant or nursing women. Women of child bearing potential who do not agree to use a highly effective method of birth control during the entire duration of the study. Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, hormonal IUDs, sexual abstinence or vasectomised partner. Female patients will be considered to be of childbearing potential unless surgically sterilised by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of severe neutropenia (DSN) in cycle 1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of febrile neutropenia (FN) in cycles 1, 2, 3 and 4 | — |
Countries
Czech Republic, Germany, Hungary, Poland, Romania, Russian Federation, Ukraine
Outcome results
None listed