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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the use of pegfilgrastim to prevent febrile neutropenia (FN) in adults with triple-negative breast cancer (TNBC) undergoing a specific chemotherapy regimen. This regimen includes anthracycline/cyclophosphamide (AC) chemotherapy following neoadjuvant treatment with paclitaxel and carboplatin. The study aims to gather real-world evidence on the safety and effectiveness of pegfilgrastim in this setting, as current data for Korean patients are limited. Participants will receive pegfilgrastim 6 mg as a subcutaneous injection once per cycle on Day 2, about 24 hours after completing each AC chemotherapy cycle. This treatment is given during four cycles of AC chemotherapy. The study is open-label and single-arm, meaning all participants receive the same treatment without placebo comparison. During the study, participants will be monitored for the occurrence of febrile neutropenia and other blood-related side effects. Researchers will track hospitalization rates related to FN, severe neutropenia, and any chemotherapy delays or dose reductions caused by neutropenia. Safety evaluations, including hematologic and non-hematologic toxicities, will continue for up to six months after treatment. The study period covers up to 12 weeks for primary outcomes and includes follow-up for safety assessments.
CONDITIONS
Brief 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 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 after paclitaxel and carboplatin as neoadjuvant therapy
- Adequate organ function including:
- Absolute neutrophil count of at least 1,000 cells/mm93
- Platelet count of at least 75,000 cells/mm93
- Creatinine clearance of at least 50 mL/min or serum creatinine less than 1.5 times the upper limit of normal
- Total bilirubin less than or equal to 1.5 times the upper limit of normal
- AST and ALT less than or equal to 2.5 times the 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 starting the study
- Active uncontrolled infection or inflammatory disease that may affect study outcomes
- Receipt of blood transfusion within 60 days before starting the study
- Pregnant, breastfeeding, or unwilling to use appropriate contraception
- Any condition judged by the investigator to make the patient unsuitable for participation
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 12 weeks
Participants receive pegfilgrastim 6 mg subcutaneously once per cycle on Day 2 during four cycles of AC chemotherapy (doxorubicin/cyclophosphamide).
4 treatment visits (in-person)
Duration - Up to 6 months after treatment ends
Participants are monitored for hematologic and non-hematologic toxicities and safety for up to 6 months after completion of treatment.
Periodic visits for safety monitoring
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
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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