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

NCT07525869 | Recruiting

• 1 other identifier: 4-2025-1181
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

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

Triple-Negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of Febrile Neutropenia (FN)

  Incidence of febrile neutropenia defined as (1) fever ≥38.3°C once or ≥38.0°C twice within 24 hours AND (2) ANC \<500/mm³ or ANC \<1,000/mm³ with a decline to \<500/mm³ within 48 hours.

  Up to 12 weeks

Secondary Outcomes (4)

• Hospitalization rate due to febrile neutropenia

  Up to 12 weeks

• Incidence of Grade 4 Neutropenia

  Up to 12 weeks

• Chemotherapy Delay or Dose Reduction Due to Neutropenia

  Up to 12 weeks

• Safety: Hematologic and Non-hematologic Toxicities

  Up to 6 months after completion of treatment

Study Arms (1)

Pegfilgrastim During AC Chemotherapy

EXPERIMENTAL

Participants receive pegfilgrastim 6 mg subcutaneously once per cycle on Day 2 during four cycles of AC chemotherapy (doxorubicin/cyclophosphamide).

Drug: Pegfilgrastim (Neulasta)

Interventions

Pegfilgrastim (Neulasta) DRUG

Pegfilgrastim 6 mg is administered subcutaneously once per cycle on Day 2 (approximately 24 ± 2 hours after completion of AC chemotherapy) for a total of four cycles (Cycle 1-4).

Pegfilgrastim During AC Chemotherapy

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.
• \. Adequate organ function:
• Absolute neutrophil count (ANC) ≥1,000 cells/mm³
• Platelet count ≥75,000 cells/mm³
• Creatinine clearance ≥50 mL/min or serum creatinine \<1.5× ULN
• Total bilirubin ≤1.5× ULN
• AST ≤2.5× ULN
• ALT ≤2.5× ULN 7. Ability to provide written informed consent and willingness to comply with study procedures.

You may not qualify if:

• \. 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).
• \. Receipt of radiotherapy within 4 weeks prior to study initiation. 5. Active uncontrolled infection or inflammatory disease that may affect study outcomes.
• \. 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.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (2)

Severance Hospital, Yonsei University Health System

Seoul, Seodaemun-gu, 03722, South Korea

RECRUITING

Gangnam Severance Hospital, Yonsei University Health System

Seoul, 06273, South Korea

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

pegfilgrastim

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Gun Min Kim, Professor

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gun Min Kim, Professor

CONTACT

02-2228-8126; gmkim77@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2026
• First Posted: April 13, 2026
• Study Start: October 28, 2025
• Primary Completion (Estimated): October 27, 2026
• Study Completion (Estimated): October 27, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)