Neutropenia in patients with high risk stage II, stage III or stage IV breast cancer receiving cancer chemotherapy.
Conditions
Interventions
Product Name: XM22
Pharmaceutical Form: Solution for injection
Current Sponsor code: XM22
Other descriptive name: GlycoPEGylated r-metHuG-CSF
Concentration unit: mg/ml milligram(s)/millilitre
Concentr
Sponsors
BioGeneriX AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Female and male patients of any ethnic origin with a diagnosis of breast cancer meeting all criteria listed below can be included in the study. • Signed and dated written informed consent. • Men and women aged = 18 years. • Breast cancer high risk stage II, or stage III or IV (classification according to American Joint Committee on Cancer [AJCC]). • Patients planned/eligible to receive treatment with docetaxel/doxorubicin as routine CTX for their breast cancer disease. • CTX-naïve. • Eastern Cooperative Oncology Group (ECOG) performance status = 2. • ANC = 1.5 x 10E9/L. • Platelet count = 100 x 10E9/L. • Adequate cardiac function (including left ventricular ejection fraction = 50% as assessed by echocardiography or equivalent method within 4 weeks prior to randomisation). • Adequate hepatic function, i.e., ALT/AST =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Participation in a clinical trial within 30 days before randomisation. • Previous exposure to filgrastim, pegfilgrastim, lenograstim, or other G-CSFs in clinical development. • Known hypersensitivity to docetaxel. • Underlying neuropathy of grade 2 or higher. • Treatment with systemically active antibiotics within 72 hours before CTX. • Treatment with lithium. • Chronic use of oral corticosteroids. • Prior radiation therapy within 4 weeks before randomisation. • Prior bone marrow or stem cell transplantation. • Prior malignancy within the previous 5 years other than basal cell or squamous cell carcinomas or in situ carcinoma of the cervix. • 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. • 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 |
|---|---|
| Main Objective: The primary objective of this study is dose-finding of a fixed dose of XM22 compared to 6 mg Neulasta® in patients with breast cancer receiving chemotherapy (CTX).;Secondary Objective: Secondary objectives are evaluation of efficacy, safety, PK, CD34+ cell mobilisation, and immunogenicity of XM22 in patients with breast cancer under CTX.;Primary end point(s): Duration of severe neutropenia (DSN) in cycle 1, defined as grade 4 neutropenia (ANC < 0.5 x 10E9/L). | — |
Countries
Czech Republic, Germany, Hungary
Outcome results
None listed