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.
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.
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.
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.
Case-control
Prospective
Not listed
Incidence of bone pain during Cycle 1
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
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.
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