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 is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Kobieta z rozpoznanym rakiem piersi potrójnie ujemnym (potwierdzone badaniem)
- •Wiek od 19 do 70 lat
- •Dobry stan ogólny (ECOG 0-1)
- •Rak piersi w stadium II-III (potwierdzone badaniem)
- •Planowana chemioterapia: paclitaxel/carboplatin, a następnie AC
- •Wystarczająca liczba białych krwinek (ANC ≥1000)
- •Wystarczająca liczba płytek krwi (≥75 000)
- •Zdolność do wyrażenia zgody i uczestniczenia w badaniu
✗ Disqualifies
- •Poprzednia chemioterapia
- •Poprzednie leczenie G-CSF lub pegylowanym G-CSF
- •Choroby wpływające na funkcję szpiku kostnego (np. poważna choroba wątroby lub nerek)
- •Radioterapia w ciągu ostatnich 4 tygodni
- •Aktywna, niekontrolowana infekcja lub zapalenie
- •Transfuzja krwi w ciągu ostatnich 60 dni
- •Ciąża, karmienie piersią lub brak chęci stosowania antykoncepcji
- •Inne warunki, które lekarz uzna za dyskwalifikujące
Simplified criteria — AI translation
Trial details
- Minimum age
- 19 Years
- Maximum age
- 70 Years
- Last updated (source)
- April 20, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (2)
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Gangnam Severance Hospital, Yonsei University Health System
Seoul, South Korea
Trial contact
Gun Min Kim, Professor
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.
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