Efficacy and safety of XM02 compared to filgrastim in patients with breast cancer receiving chemotherapy: A multinational, multicentre, randomised, controlled study

Completed

Conditions: Breast cancer treated by myelotoxic chemotherapy
Cancer
Malignant neoplasm of breast

Registration Number: ISRCTN02270769

Lead Sponsor: BioGeneriX AG (Germany)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 350

Inclusion Criteria

1. Signed and dated written informed consent
2. Age above or equal 18 years, both males and females
3. Breast cancer high risk stage II, or stage III or IV (classification according to American Joint Committee on Cancer [AJCC])
4. Patients planned/eligible to receive treatment with docetaxel/doxorubicin as routine chemotherapy (CTX) for their breast cancer disease
5. CTX naïve
6. Eastern Cooperative Oncology Group (ECOG) performance status below or equal 2
7. Absolute neutrophil count (ANC) above or equal 1.5 x 10^9/L
8. Platelet count above or equal 100 x 10^9/L
9. Adequate cardiac function (including left ventricular ejection fraction above or equal 50% as assessed by echocardiography within 4 weeks prior to randomisation)
10. Adequate hepatic function i.e., alanine and aspartate aminotransferases (ALT/AST) <2.5 x upper limit of normal (ULN), alkaline phosphatase (AP) <5 x ULN, bilirubin 11. Adequate renal function, i.e., creatinine <1.5 x

Exclusion Criteria

1. Participation in a clinical trial within 30 days before randomisation
2. Previous exposure to filgrastim, pegfilgrastim or lenograstim
3. Known hypersensitivity to docetaxel
4. Underlying neuropathy of grade 2 or higher
5. Treatment with systemically active antibiotics within 72 hours before CTX
6. Treatment with lithium
7. Chronic use of oral corticosteroids
8. Prior radiation therapy within 4 weeks before randomisation
9. Prior bone marrow or stem cell transplantation
10. Prior malignancy within the previous 5 years other than basal cell or squamous cell carcinomas or in situ carcinoma of the cervix
11. Any illness or condition that in the opinion of the investigator could affect the safety of the patient or the evaluation of any study endpoint
12. Pregnant or nursing women were excluded. Women of child-bearing potential had to agree to use a chemical or barrier contraceptive during the treatment period.