An Open-label Prospective Study to Evaluate the Efficacy and Safety of Pegfilgrastim in Tr
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 therap
| Condition(s) | Triple-Negative Breast Cancer |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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 cyc |
| Who can participate | Inclusion Criteria: * 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. 6\. Adequate organ function: 1. Absolute neutrophil count (ANC) ≥1,000 cells/mm³ 2. Platelet count ≥75,000 cells/mm³ 3. Creatinine clearance ≥50 mL/min or serum creatinine \<1.5× ULN 4. Total bilirubin ≤1.5× ULN 5. AST ≤2.5× ULN 6. ALT ≤2.5× ULN 7. Ability to provide written informed consent and willingness to comply with study procedures. Exclusion Criteria: * 1\. Prior treatment with cytotoxic chemotherapy. 2. Prior treatment with G-CSF or pegylated G-CSF. 3. History |
| Ages | 19 Years to 70 Years |
| Sex | All |
| Lead sponsor | Yonsei University |
| Locations | Seoul, Seodaemun-gu, South Korea; Seoul, South Korea |
| Start date | 2025-10-28 |
| NCT ID | NCT07525869 |
| Official listing | https://clinicaltrials.gov/study/NCT07525869 |