An Open-label Prospective Study to Evaluate the Efficacy and Safety of Pegfilgrastim in Triple-Negative Breast Cancer Patients Receiving AC Regimen Following Paclitaxel and Carboplatin as Neoadjuvant Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pegfilgrastim (Neulasta).
- Who it may be relevant to
- Registry conditions: Triple-Negative Breast Cancer. Basic parameters: 19 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Pegfilgrastim (Neulasta)
Pegfilgrastim 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).
Primary outcome measures
- Incidence of Febrile Neutropenia (FN) [Time frame: Up to 12 weeks]
Secondary outcome measures (4)
- Hospitalization rate due to febrile neutropenia [Time frame: Up to 12 weeks]
- Incidence of Grade 4 Neutropenia [Time frame: Up to 12 weeks]
- Chemotherapy Delay or Dose Reduction Due to Neutropenia [Time frame: Up to 12 weeks]
- Safety: Hematologic and Non-hematologic Toxicities [Time frame: Up to 6 months after completion of treatment]
Eligibility criteria
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:
- 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
- Total bilirubin ≤1.5× ULN
- AST ≤2.5× ULN
- 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 of conditions that may affect bone marrow function (e.g., severe liver or kidney disease).
4\. Receipt of radiotherapy within 4 weeks prior to study initiation. 5. Active uncontrolled infection or inflammatory disease that may affect study outcomes.
6\. Receipt of blood transfusion within 60 days prior to study initiation. 7. Pregnant, breastfeeding, or unwilling to use appropriate contraception. 8. Any condition judged by the investigator to make the patient unsuitable for participation.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
South Korea · 2 centers
- Severance Hospital, Yonsei University Health System — Seoul
- Gangnam Severance Hospital, Yonsei University Health System — Seoul
Identifiers
NCT: NCT07525869 · 4-2025-1181