Efficacy and Safety of XM22 compared to pegfilgrastim in patients with breast cancer receiving chemotherapy. A multinational, multicentre, randomised, double-blind controlled study

Conditions: Breast cancer high risk stage II, III or IV according to AJCC classification
MedDRA version: 12.0Level: PTClassification code 10006200Term: Breast cancer stage II
MedDRA version: 12.0Level: PTClassification code 10006201Term: Breast cancer stage III
MedDRA version: 12.0Level: PTClassification code 10006202Term: Breast cancer stage IV

Registration Number: EUCTR2009-015999-10-BG

Lead Sponsor: BioGeneriX AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 250

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) <2.5 x upper limit of normal (ULN), alkaline phosphatase <5 x ULN, bilirubin • Adequate renal function, i.e. creatinine <1.5 x ULN.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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