Conditions: Neutropenic Complications Breast Neoplasms Chemotherapy-induced Neutropenia Chemotherapeutic Toxicity
Keywords: biosimilars Pegfilgrastim, G-CSF, neutropenia, breast cancer, myelosuppressive chemotherapy, supportive care granulocyte-colony-stimulating factor
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 316
Healthy volunteers: no

Brief summary:
The study will assess the efficacy of LA-EP2006 compared to Neulasta® with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.

Detailed description:
This randomized, double-blind trial compared the proposed biosimilar LA-EP2006 with the reference Neulasta® in women (≥18 years) receiving chemotherapy for breast cancer. Therefore patients were randomized to receive LA-EP2006 (n = 159) or the reference product (n = 157) for ≤6 cycles of (neo)-adjuvant TAC (docetaxel 75mg/m\^2, doxorubicin 50 mg/m\^2, and cyclophosphamide 500mg/m\^2) chemotherapy. The primary end point was the duration of severe neutropenia (DSN) during Cycle 1 (defined as number of consecutive days with absolute neutrophil count \<0.5 × 10\^9/l). The equivalence was confirmed if 95% CIs were within a ±1 day margin. LA-EP2006 was equivalent to the reference product in DSN (difference: 0.07 days; 95% CI \[-0.12, 0.26\]). Further, LA-EP2006 and the reference Neulasta® showed no clinically meaningful differences regarding efficacy and safety.

Arms:
arm 1: During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application. arm 2: During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.

Interventions: intervention 1: LA-EP2006 intervention 2: Neulasta®
Intervention descriptions: intervention 1: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application. intervention 2: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.

Protocol document: