Efficacy and Safety of XM 02 compared to Filgrastim in patients with breast cancer receiving chemotherapy. Multinational, multicentre, randomised, controlled study

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 280

Inclusion Criteria

Female and male patients of any ethnic origin with a diagnosis of breast cancer meeting all criteria listed below, will be included in the study.
- Signed and dated written informed consent
- Age 18 years and above
- Breast cancer high risk stage II, or stage III or IV (classification according to American Joint Committee on Cancer [AJCC] see appendix to the protocol)
- Patients planned/eligible to receive treatment with docetaxel/doxorubicin as routine chemotherapy for their breast cancer disease
- Chemotherapy naïve or have received no more than one previous regimen of chemotherapy
- Completion of previous chemotherapy more than 4 weeks before randomisation
- Eastern Cooperative Oncology Group (ECOG) performance status £2
- Platelet count equal/more then 100 x 109/L
- Adequate cardiac function (including left ventricular ejection fraction equal/more then 50% as assessed by echocardiography)
- Adequate hepatic function i.e., alanine and aspartate aminotransferases (ALT/AST) <2.5 x upper normal limit (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

Patients presenting with any of the following will not be included in the study:
- Participation in a clinical trial within 30 days before randomisation
- Previous exposure to Filgrastim, Pegfilgrastim or Lenograstim
- Known hypersensitivity to Docetaxel
- Underlying neuropathy of grade 2 or higher
- Treatment with systemically active antibiotics within 72 hours before chemotherapy
- Treatment with lithium
- Chronic use of oral corticosteroids
- Prior radiation therapy within 4 weeks before randomisation
- Prior bone marrow or stem cell transplantation
- Prior total lifetime exposure to doxorubicin >240 mg/m² or epirubicin >600 mg/m²
- 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 are excluded. Women of child-bearing potential must agree to use a chemical or barrier contraceptive during the treatment period

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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