This open-label, prospective, single-arm clinical study aims to evaluate the efficacy and safety of pegfilgrastim in preventing febrile neutropenia (FN) among patients with triple-negative breast cancer (TNBC) receiving anthracycline/cyclophosphamide (AC) chemotherapy following neoadjuvant paclitaxel/carboplatin therapy. In the Keynote-522 regimen, paclitaxel and carboplatin are administered prior to the AC phase, which may increase cumulative myelosuppression and subsequently elevate the risk of FN during AC. Despite this clinical concern, real-world evidence supporting the prophylactic use of pegfilgrastim in Korean patients undergoing this regimen remains insufficient.
A total of 40 adult TNBC patients will be enrolled. Pegfilgrastim 6 mg will be administered subcutaneously once per cycle on Day 2 of each AC cycle (Cycles 1-4), approximately 24 hours after chemotherapy completion. The primary objective is to assess the incidence of FN during the four AC cycles. Secondary objectives include hospitalization due to FN, incidence of Grade 4 neutropenia, delays or dose reductions in chemotherapy due to neutropenia, and evaluation of hematologic and non-hematologic toxicities.
This study is descriptive in nature and does not involve hypothesis-testing sample size calculations. The sample size of 40 was determined based on feasible drug supply and is expected to provide clinically meaningful insight when compared with existing real-world data, in which the FN risk during AC without prophylactic G-CSF is historically reported at approximately 20-25%. The findings from this study may offer essential clinical evidence supporting the preventive use of pegfilgrastim during the AC phase in TNBC patients treated with the paclitaxel/carboplatin-leading neoadjuvant regimen.
1. Women diagnosed with triple-negative breast cancer by pathology or cytology. 2. Age ≥19 and ≤70 years. 3. ECOG performance status 0-1. 4. Stage II-III breast cancer confirmed pathologically or clinically. 5. Planned to receive AC chemotherapy following paclitaxel/carboplatin as neoadjuvant therapy.
Absolute neutrophil count (ANC) ≥1,000 cells/mm³
Platelet count ≥75,000 cells/mm³
Creatinine clearance ≥50 mL/min or serum creatinine <1.5× ULN
1. Prior treatment with cytotoxic chemotherapy. 2. Prior treatment with G-CSF or pegylated G-CSF. 3. History of conditions that may affect bone marrow function (e.g., severe liver or kidney disease).
Single group
Pegfilgrastim (Neulasta)
DrugPegfilgrastim 6 mg is administered subcutaneously once per cycle on Day 2 (approximately 24 ± 2 hours after completion of AC chemotherapy) for a total of four cycles (Cycle 1-4).
Incidence of Febrile Neutropenia (FN)
Incidence of febrile neutropenia defined as (1) fever ≥38.3°C once or ≥38.0°C twice within 24 hours AND (2) ANC \<500/mm³ or ANC \<1,000/mm³ with a decline to \<500/mm³ within 48 hours.
Hospitalization rate due to febrile neutropenia
Proportion of participants requiring hospitalization due to febrile neutropenia.
Incidence of Grade 4 Neutropenia
Incidence of Grade 4 neutropenia assessed by laboratory values at each chemotherapy cycle.
Chemotherapy Delay or Dose Reduction Due to Neutropenia
Proportion of participants experiencing AC dose delay or dose reduction due to neutropenia.
Safety: Hematologic and Non-hematologic Toxicities
Assessment of hematologic and non-hematologic adverse events based on NCI CTCAE v5.0.
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