Actively Recruiting
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
Led by Yonsei University · Updated on 2026-04-20
40
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women diagnosed with triple-negative breast cancer confirmed by pathology or cytology
- Age between 19 and 70 years
- ECOG performance status of 0 or 1
- Stage II-III breast cancer confirmed pathologically or clinically
- Planned to receive anthracycline/cyclophosphamide chemotherapy following paclitaxel/carboplatin neoadjuvant therapy
- Adequate organ function including absolute neutrophil count ≥1,000 cells/mm³, platelet count ≥75,000 cells/mm³, creatinine clearance ≥50 mL/min or serum creatinine <1.5× upper limit of normal, total bilirubin ≤1.5× upper limit of normal, AST ≤2.5× upper limit of normal, ALT ≤2.5× upper limit of normal
- Ability to provide written informed consent and willingness to comply with study procedures
You will not qualify if you...
- Prior treatment with cytotoxic chemotherapy
- Prior treatment with G-CSF or pegylated G-CSF
- History of conditions affecting bone marrow function such as severe liver or kidney disease
- Receipt of radiotherapy within 4 weeks before study start
- Active uncontrolled infection or inflammatory disease affecting study outcomes
- Receipt of blood transfusion within 60 days before study start
- Pregnant, breastfeeding, or unwilling to use appropriate contraception
- Any condition that makes the patient unsuitable for participation as judged by the investigator
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Trial Site Locations
Total: 2 locations
1
Severance Hospital, Yonsei University Health System
Seoul, Seodaemun-gu, South Korea, 03722
Actively Recruiting
2
Gangnam Severance Hospital, Yonsei University Health System
Seoul, South Korea, 06273
Actively Recruiting
Research Team
G
Gun Min Kim, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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