Breast cancer high risk stage II, III or IV according to AJCC classification MedDRA version: 12.0 Level: PT Classification code 10006200 Term: Breast cancer stage II MedDRA version: 12.0 Level: PT Classification code 10006201 Term: Breast cancer stage III MedDRA version: 12.0 Level: PT Classification code 10006202 Term: Breast cancer stage IV
Conditions
Sponsors
BioGeneriX AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Written informed consent. • Men and women aged =18 years. • The patient must be able to understand and follow instructions and must be able to participate in the study for the entire period. • Breast cancer high risk stage II, III or IV according to American Joint Committee on Cancer (AJCC) classification • Patients planned and eligible to receive 4 cycles of treatment with docetaxel/doxorubicin as routine chemotherapy for their breast cancer disease. • Chemotherapy naive. • Eastern Cooperative Oncology Group (ECOG) performance status =2. • ANC =1.5 x 10(9)/L. • Platelet count =100 x 10(9)/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. alanine and aspartate aminotransferases (ALT and 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 or lenograstim or other G-CSFs in clinical development less than 6 months before randomisation. • Known hypersensitivity to docetaxel or doxorubicin, filgrastim, pegfilgrastim or lenograstim. • Underlying neuropathy of grade 2 or higher. • Treatment with systemically active antibiotics within 72 hours before chemotherapy. • Treatment with lithium at inclusion or planned during the entire study. • Chronic use of oral corticosteroids. • Prior radiation therapy or tumour surgery 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Demonstration of non-inferiority of XM22 versus pegfilgrastim (Neulasta® – Amgen) in patients with breast cancer during the first cycle of chemotherapy with respect to the duration of severe neutropenia (DSN).;Secondary Objective: 1. Demonstration of efficacy and safety of XM22 in comparison to pegfilgrastim in patients with breast cancer under chemotherapy based on the secondary efficacy and safety endpoints. 2. Evaluation of pharmacokinetic properties of XM22 in comparison to pegfilgrastim.;Primary end point(s): DSN in cycle 1, defined as grade 4 neutropenia with an ANC <0.5 x 10(9)/L. | — |
Countries
Bulgaria
Outcome results
None listed