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Can a simple shot keep breast cancer patients safe from infection?

NCT ID NCT07525869

Disease control Sponsor: Yonsei University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a drug called pegfilgrastim (Neulasta) can prevent a dangerous drop in white blood cells and fever (febrile neutropenia) in women with triple-negative breast cancer. The 40 participants receive the drug after each round of AC chemotherapy, which follows earlier chemo with paclitaxel and carboplatin. The goal is to see if this approach reduces infections and hospital stays.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pegfilgrastim (Neulasta)
What this could lead to
If it works, this could provide evidence that pegfilgrastim safely prevents serious infections during chemotherapy for triple-negative breast cancer patients.
What could go wrong
This is a small, early-phase study with only 40 participants and no comparison group, so results may not be conclusive or apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

triple-negative breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Triple negative breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Gangnam Severance Hospital, Yonsei University Health System

    RECRUITING

    Seoul, 06273, South Korea

  • Severance Hospital, Yonsei University Health System

    RECRUITING

    Seoul, Seodaemun-gu, 03722, South Korea

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