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

INTERVENTION: 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 will be 360 days. CONDITION: Breast cancer patients with chemotherapy induced neutropenia ; Cancer ; Malignant neoplasm of breast; Agranulocytosis PRIMARY OUTCOME: Duration of severe neutropenia in cycle 1, defined as grade 4 neutropenia with an ANC <0.5 x 10*9/L SECONDARY OUTCOME: 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 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

Epistemonikos ID: 445685d49809ba34c462fb3de1ddb478caf8d77a
First added on: Aug 22, 2024