Pegfilgrastim to prevent fever and low white blood cells during AC chemotherapy after paclitaxel and carboplatin in triple‑negative breast cancer
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
This will test whether a single 6 mg pegfilgrastim shot given about 24 hours after each AC chemotherapy cycle can prevent febrile neutropenia in adults with triple‑negative breast cancer who previously received paclitaxel and carboplatin.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 19 Years to 70 Years |
| Sex | All |
| Sponsor | Yonsei University Academic / other |
| Drugs / interventions | chemotherapy, cyclophosphamide |
| Locations | 2 sites (Seoul, Seodaemun-gu and 1 other locations) |
| Trial ID | NCT07525869 on ClinicalTrials.gov |
What this trial studies
This open‑label, prospective, single‑arm study will enroll 40 adults with stage II–III triple‑negative breast cancer in Korea who proceed to four cycles of anthracycline/cyclophosphamide (AC) after neoadjuvant paclitaxel/carboplatin. Participants will receive 6 mg pegfilgrastim subcutaneously on Day 2 of each AC cycle (approximately 24 hours after chemotherapy) and will be followed for the incidence of febrile neutropenia across the four AC cycles as the primary outcome. Safety, tolerability, and routine laboratory monitoring of blood counts and organ function will be collected as secondary data. The trial aims to fill a real‑world evidence gap about prophylactic pegfilgrastim use in this specific treatment sequence in Korean TNBC patients.
Who should consider this trial
Good fit: Adult women (age 19–70) with pathologically confirmed stage II–III triple‑negative breast cancer, ECOG 0–1, adequate organ function, and planned to receive AC chemotherapy after neoadjuvant paclitaxel/carboplatin are ideal candidates.
Not a fit: Patients with prior cytotoxic chemotherapy or prior G‑CSF/pegylated G‑CSF use, significant marrow‑affecting comorbidities, recent radiotherapy, or inadequate organ function are unlikely to be eligible or to benefit from this protocol.
Why it matters
Potential benefit: If successful, pegfilgrastim could reduce episodes of fever and infection from low white blood cells and help patients stay on schedule with AC chemotherapy.
How similar studies have performed: G‑CSF agents like pegfilgrastim have been shown broadly to reduce febrile neutropenia risk across many chemotherapy settings, but direct evidence for this exact sequence after paclitaxel/carboplatin in Korean TNBC patients is limited.
Eligibility criteria
Show full inclusion / exclusion 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:
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 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.
Where this trial is running
Seoul, Seodaemun-gu and 1 other locations
- Severance Hospital, Yonsei University Health System — Seoul, Seodaemun-gu, South Korea (Recruiting)
- Gangnam Severance Hospital, Yonsei University Health System — Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: Gun Min Kim, Professor — Severance Hospital
- Study coordinator: Gun Min Kim, Professor
- Email: gmkim77@yuhs.ac
- Phone: 02-2228-8126
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.