Pegfilgrastim to prevent fever and low white blood cells during AC chemotherapy after paclitaxel and carboplatin in triple‑negative breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.