Triple-Negative Breast CancerNCT07525869
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
A study testing Pegfilgrastim (Neulasta) in people with Triple-Negative Breast Cancer, run by Yonsei University at 2 sites in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Triple-Negative Breast Cancer
- What is being tested?
- Pegfilgrastim (Neulasta)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 28 Oct 2025to 27 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea2 sites, 2 recruiting
- Recruiting
Severance Hospital, Yonsei University Health System
Seoul, Seodaemun-gu, 03722
Gun Min Kim, 02-2228-8126, gmkim77@yuhs.ac
- Recruiting
Gangnam Severance Hospital, Yonsei University Health System
Seoul, 06273
Jee Hung KIM, +82 02-2019-3305, OK8504@yuhs.ac
About this study
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
- Being tested
- Pegfilgrastim (Neulasta)
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Pegfilgrastim (Neulasta) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 12 weeks
Secondary outcomes (4)
Hospitalization rate due to febrile neutropenia
Proportion of participants requiring hospitalization due to febrile neutropenia.
Measured: Up to 12 weeks
Incidence of Grade 4 Neutropenia
Incidence of Grade 4 neutropenia assessed by laboratory values at each chemotherapy cycle.
Measured: Up to 12 weeks
Chemotherapy Delay or Dose Reduction Due to Neutropenia
Proportion of participants experiencing AC dose delay or dose reduction due to neutropenia.
Measured: Up to 12 weeks
Safety: Hematologic and Non-hematologic Toxicities
Assessment of hematologic and non-hematologic adverse events based on NCI CTCAE v5.0.
Measured: Up to 6 months after completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start28 Oct 2025
- Primary completion27 Oct 2026 (estimated)
- Study completion27 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple-Negative Breast CancerStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gun Min Kim, Professor, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07525869
- Sponsor's protocol ID
- 4-2025-1181
- Status last verified
- Apr 2026
- First submitted
- 22 Mar 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07525869
- Acronym / sponsor ID
- 4-2025-1181
- Conditions
- Triple-Negative Breast Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 28 Oct 2025 (actual)
- Primary completion
- 27 Oct 2026 (estimated)
- Study completion
- 27 Oct 2026 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pegfilgrastim During AC Chemotherapy | Experimental | Drug: Pegfilgrastim (Neulasta)Participants receive pegfilgrastim 6 mg subcutaneously once per cycle on Day 2 during four cycles of AC chemotherapy (doxorubicin/cyclophosphamide). |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pegfilgrastim (Neulasta)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). | Drug | Pegfilgrastim During AC Chemotherapy |
Primary outcome
Incidence of Febrile Neutropenia (FN)
Time frame: Up to 12 weeks
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.
4 secondary outcomes
Hospitalization rate due to febrile neutropenia
Time frame: Up to 12 weeks
Incidence of Grade 4 Neutropenia
Time frame: Up to 12 weeks
Chemotherapy Delay or Dose Reduction Due to Neutropenia
Time frame: Up to 12 weeks
Safety: Hematologic and Non-hematologic Toxicities
Time frame: Up to 6 months after completion of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gun Min Kim, Professor principal investigator
Severance Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pegfilgrastim (Neulasta) in people with Triple-Negative Breast Cancer, run by Yonsei University at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gun Min Kim, Professor (02-2228-8126, gmkim77@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Febrile Neutropenia (FN) (time frame: Up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.