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Can a newer drug ease the bone pain of chemotherapy support?

NCT ID NCT07806084

Symptom relief Sponsor: The First Affiliated Hospital with Nanjing Medical University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time

Summary

This study looks at whether a long-acting G-CSF called telpegfilgrastim causes less bone pain than other long-acting G-CSFs in breast cancer patients receiving chemotherapy. About 132 patients will be divided into two groups based on which G-CSF their doctor prescribes. Researchers will track bone pain during the first chemotherapy cycle and monitor neutrophil levels to see if there is a link. The goal is to find a way to prevent infections with fewer side effects.

What this could mean

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

Active substance
Telpegfilgrastim, a long-acting G-CSF, compared with other approved long-acting G-CSFs
What this could lead to
If telpegfilgrastim causes less bone pain, it could become a preferred option for preventing infections during chemotherapy, improving comfort and adherence.
What could go wrong
This is a non-randomized study with a moderate size, so results may be influenced by patient differences. Bone pain is subjective, and the comparison may not show a clear difference.

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.

Participants

About 132 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Mar 2027

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.

Who is studied

Patients with breast cancer receiving neoadjuvant or adjuvant chemotherapy with anthracycline- and/or taxane-containing regimens associated with a moderate-to-high risk of febrile neutropenia will be enrolled from 7 participating centers in China. Eligible patients receive prophylactic long-acting G-CSF according to the treating physician's clinical decision and are classified into the Telpegfilgrastim cohort or the other long-acting G-CSF cohort. Patients are followed for at least 3 chemotherapy cycles to evaluate bone pain, neutrophil counts, treatment for bone pain, and changes in long-acting G-CSF use.

Ages

18 to 69 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. Histologically or cytologically confirmed breast cancer. 2. Patients considered by the investigator to be suitable for neoadjuvant or adjuvant chemotherapy with an anthracycline- and/or taxane-containing regimen administered in 21-day cycles, and expected to receive at least 3 chemotherapy cycles. 3. Age ≥18 years and \<70 years. 4. Body weight ≥45 kg. 5. Eastern Cooperative Oncology Group (ECOG) performance status ≤2. 6. Adequate baseline white blood cell and neutrophil counts before chemotherapy: white blood cell count (WBC) ≥3.5 × 10\^9/L and absolute neutrophil count (ANC) ≥1.5 × 10\^9/L. 7. Expected survival ≥3 months. 8. Willing to participate in the study, able to understand the study procedures, and able to provide written informed consent. Exclusion Criteria: 1. Previous or anticipated large-field radiotherapy involving \>25% of the total bone marrow. 2. Significant dysfunction of major organs, including heart, lung, liver, or kidney; liver function abnormalities defined as ALT or total bilirubin \>2.5 × ULN, or \>5 × ULN in patients with liver metastases; hepatitis B virus infection, hepatitis C virus infection, or cirrhosis; or serum creatinine \>1.5 × ULN. 3. Pregnant or breastfeeding women. 4. Previous or ongoing bone marrow transplantation or organ transplantation. 5. Known hypersensitivity to G-CSF or any component of a G-CSF product. 6. Patients who are unable to reliably understand or report their medical condition. 7. Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in the study.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm chemotherapy-induced toxicity Febrile Neutropenia

As listed by the trial registrant

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

Bone pain Breast cancer Chemotherapy-induced neutropenia Febrile neutropenia

How to take part

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

  1. 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 ↗

  2. 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.

More trials for these conditions

Other studies related to the condition(s) this trial covers.