Breast cancer patients with chemotherapy induced neutropenia Cancer Malignant neoplasm of breast
Conditions
Interventions
XM22: 1 syringe 6 mg per cycle (cycles 1-4)
Pegfilgrastim: 1 syringe 6 mg per cycle (cycles 1-4)
The duration of the study will be 12 weeks. The duration of follow up
Sponsors
BioGeneriX AG (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
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 <ULN 12. Adequate renal function, i.e. creatinine <1.5 x ULN
Exclusion criteria
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of severe neutropenia in cycle 1, defined as grade 4 neutropenia with an ANC <0.5 x 10*9/L | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence of febrile neutropenia (FN) by cycle and across all cycles (FN defined as body temperature of >38.5°C for at least one hour, measured orally with a certified standard device, and ANC <0.5 x 10*9/L, including cases of neutropenic sepsis or neutropenic serious or life-threatening infection) 2. Time in hospital and time in intensive care unit due to FN or connected infections 3. Incidence of treatment with i.v. antibiotics due to FN or connected infections 4. DSN in cycles 2, 3, and 4 5. Incidence of severe neutropenia, defined as grade 4 neutropenia with an ANC <0.5 x 10*9/L in cycles 1, 2, 3 and 4 6. Duration and incidence of very severe neutropenia, defined as ANC <0.1 x 10*9/L in cycles 1, 2, 3 and 4 7. Depth of ANC nadir in cycles 1, 2, 3, and 4 8. Time to ANC nadir in cycles 1, 2, 3, and 4 9. Time to ANC recovery in cycles 1, 2, 3, and 4 10. Percentage of actually delivered vs. scheduled cumulative chemotherapy dose 11. Proportion of patients with chemotherapy doses reduced, omitted, or delayed 12. Number of days of delay of chemotherapy 13. Overall quality of life as measured by the EORTC QLQ-C30 (version 3) and the EORTC QLQ-BR23 | — |
Countries
Bulgaria, Russian Federation, Ukraine
Outcome results
None listed