Efficacy and safety of XM22 compared to pegfilgrastim in patients with breast cancer receiving chemotherapy

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 200

Inclusion Criteria

1. Provide signed and dated written informed consent
2. Men and women aged =18 years
3. The patient must be able to understand and follow instructions and must be able to participate in the study for the entire period
4. Breast cancer high risk stage II, III or IV according to American Joint Committee on Cancer (AJCC) classification
5. Patients planned and eligible to receive 4 cycles of treatment with docetaxel/doxorubicin as routine chemotherapy for their breast cancer disease
6. Chemotherapy naïve
7. Eastern Cooperative Oncology Group (ECOG) performance status =2
8. Absolute Neutrophil Count (ANC) =1.5 x 10*9/L
9. Platelet count =100 x 10*9/L
10. Adequate cardiac function (including left ventricular ejection fraction =50% as assessed by echocardiography or equivalent method within 4 weeks prior to randomisation)
11. Adequate hepatic function, i.e. ALT and AST <2.5 x ULN, alkaline phosphatase <5 x ULN, bilirubin 12. Adequate renal function, i.e. creatinine <1.5 x ULN

Exclusion Criteria

1. Participation in a clinical trial within 30 days before randomisation.
2. Previous exposure to filgrastim, pegfilgrastim or lenograstim or other G-CSFs in clinical development less than 6 months before randomisation.
3. Known hypersensitivity to docetaxel or doxorubicin, filgrastim, pegfilgrastim or lenograstim.
4. Underlying neuropathy of grade 2 or higher.
5. Treatment with systemically active antibiotics within 72 hours before chemotherapy.
6. Treatment with lithium at inclusion or planned during the entire study.
7. Chronic use of oral corticosteroids.
8. Prior radiation therapy or tumour surgery 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 may affect the safety of the patient or the evaluation of any study endpoint.
12. 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. Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, hormonal IUDs, sexual abstinence or vasectomised partner. Female patients will be considered to be of child-bearing potential unless surgically sterilised by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years (Postmenopausal is defined as the time after which a woman has experienced twelve consecutive months of amenorrhea without a period).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Duration of severe neutropenia in cycle 1, defined as grade 4 neutropenia with an ANC <0.5 x 10*9/

Secondary Outcome Measures

Name	Time	Method

Related Trials