Correlation Between ANC and Bone Pain in Breast Cancer Patients Receiving Long-Acting G-CSF

This prospective, multicenter, non-randomized controlled study aims to evaluate bone pain associated with prophylactic use of long-acting granulocyte colony-stimulating factors (G-CSFs) in patients with breast cancer receiving chemotherapy with a moderate-to-high risk of febrile neutropenia (FN).

A total of 132 patients with breast cancer receiving neoadjuvant or adjuvant chemotherapy will be enrolled at 7 study centers in China. According to the long-acting G-CSF selected by the treating physician in routine clinical practice, patients will be included in either the Telpegfilgrastim group or the non-Telpegfilgrastim group. Telpegfilgrastim is administered as a fixed 2 mg subcutaneous dose 24 hours after chemotherapy. Patients in the non-Telpegfilgrastim group receive another approved long-acting G-CSF according to the physician's clinical decision.

The study will assess the incidence and duration of bone pain during the first chemotherapy cycle as the primary outcome. Bone pain during subsequent chemotherapy cycles, use of treatment for bone pain, and dose reduction or switching of long-acting G-CSF will also be evaluated. Absolute neutrophil count (ANC) and other laboratory parameters will be monitored during treatment to explore the relationship between neutrophil changes and bone pain.

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Key information

Conditions

Breast Cancer Agranulocytosis Bone Pain Breast Diseases Breast Neoplasms Chemotherapy-induced Neutropenia Cytopenia Febrile Neutropenia Hematologic Diseases Hemic and Lymphatic Diseases Leukocyte Disorders Leukopenia Neoplasms Neoplasms by Site Neutropenia Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Histologically or cytologically confirmed breast cancer.
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.
Age ≥18 years and <70 years.
Body weight ≥45 kg.
Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
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.
Expected survival ≥3 months.
Willing to participate in the study, able to understand the study procedures, and able to provide written informed consent.

Exclusion criteria

Previous or anticipated large-field radiotherapy involving >25% of the total bone marrow.
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.
Pregnant or breastfeeding women.
Previous or ongoing bone marrow transplantation or organ transplantation.
Known hypersensitivity to G-CSF or any component of a G-CSF product.
Patients who are unable to reliably understand or report their medical condition.
Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in the study.

Treatment and study plan

Primary outcomes

Incidence of bone pain during Cycle 1

Time frame: During Cycle 1, up to 21 days after chemotherapy

The number and proportion of participants who experience bone pain during the first chemotherapy cycle will be assessed in the Telpegfilgrastim cohort and the other long-acting G-CSF cohort. Bone pain will be evaluated using the Numeric Rating Scale (NRS), ranging from 0 to 10.
Duration of bone pain during Cycle 1

Time frame: During Cycle 1, up to 21 days after chemotherapy

The duration of bone pain will be defined as the number of consecutive days with bone pain after administration of the long-acting G-CSF during the first chemotherapy cycle.

Study contacts

Contact information is provided by the study sponsor or research team.

Wei Li

CONTACT

[email protected]

+86 13851603656

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Registry information

Official study title

A Prospective, Multicenter, Non-Randomized Controlled Study on the Correlation Between Absolute Neutrophil Count (ANC) and Bone Pain During the Prevention of Chemotherapy-Induced Neutropenia and Febrile Neutropenia (CIN/FN) With Long-Acting G-CSF in Breast Cancer Patients Receiving Intermediate- to High-Risk Chemotherapy

Acronym: Bone Pain

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Sep 8, 2026
Registry last updated: Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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