Dose-finding of a fixed dose XM22 in patients with breast cancer receiving 4 cycles of chemotherapy versus 6 mg Neulasta®

INTERVENTION: Participants will be randomly allocated to the following two arms: 1. Neulasta®, 6 mg, administered subcutaneously once per chemotherapy cycle 2. XM22 administered subcutaneously once per chemotherapy cycle CONDITION: Breast cancer ; Cancer ; Malignant neoplasm of breast PRIMARY OUTCOME: Duration of severe neutropenia (DSN) in cycle 1 SECONDARY OUTCOME: Incidence of febrile neutropenia (FN) in cycles 1, 2, 3 and 4 INCLUSION CRITERIA: 1. Men and women aged >= 18 years 2. Signed and dated written informed consent 3. Breast cancer high risk stage II, or stage III or IV 4. Patients planned/eligible to receive treatment with docetaxel/doxorubicin as routine chemotherapy for their breast cancer disease 5. Chemotherapy‐naïve 6. Eastern Cooperative Oncology Group (ECOG) performance status <= 2 7. ANC >= 1.5 x 10^9/L 8. Platelet count >= 100 x 10^9/L 9. Adequate cardiac function (including left ventricular ejection fraction >= 50% as assessed by echocardiography or equivalent method within 4 weeks prior to randomisation) 10. Adequate hepatic function, i.e., alanine aminotransferase (ALT)/aspartate transaminase (AST) <2.5 x upper limit of normal (ULN), alkaline phosphatase <5 x ULN, bilirubin

Epistemonikos ID: 04defdac200a44c0144bbaa3c38a3810f820274a
First added on: Aug 21, 2024