Efficacy and Safety of XM 02 compared to Filgrastim in patients with breast cancer receiving chemotherapy. Multinational, multicentre, randomised, controlled study
- Conditions
- Patients with breast cancer high risk stage II or stage III/IV (classification according to American Joint Committee on Cancer [AJCC] receiving chemotherapy and developing Neutropenia due to chemotherapy.
- Registration Number
- EUCTR2004-001452-36-HU
- Lead Sponsor
- BioGeneriX
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 280
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
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
- 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 Main Objective: Demonstration of equivalence of XM 02 and Filgrastim (Neupogen® - Amgen) in patients with breast cancer during the first cycle of chemotherapy with respect to the respect to the duration of severe neutropenia (DSN). <br>;Secondary Objective: Demonstration of efficacy and safety of XM 02 in comparison to Filgrastim in patients with breast cancer under chemotherapy based on the secondary endpoints. Evaluation of pharmacokinetic properties of XM 02 in comparison to Filgrastim<br>;Primary end point(s): Efficacy: <br>Duration of severe neutropenia (DSN) in cycle 1, defined as grade 4 neutropenia with an ANC <0.5 x 109/L<br>
- Secondary Outcome Measures
Name Time Method