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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 132
- 主要终点
- Incidence of bone pain during Cycle 1
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 ≤
- •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.
排除标准
- •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.
研究组 & 干预措施
Telpegfilgrastim Cohort
Patients with breast cancer who receive telpegfilgrastim for prophylaxis of chemotherapy-induced neutropenia according to the treating physician's clinical decision. Telpegfilgrastim is administered at a fixed dose of 2 mg by subcutaneous injection 24 hours after chemotherapy, once per chemotherapy cycle.
Other Long-acting G-CSF Cohort
Patients with breast cancer who receive a long-acting G-CSF other than telpegfilgrastim for prophylaxis of chemotherapy-induced neutropenia according to the treating physician's clinical decision. The long-acting G-CSF may include PEG-rhG-CSF, mecapegfilgrastim, or efbemalenograstim alfa, administered according to the approved dose and routine clinical practice.
结局指标
主要结局
Incidence of bone pain during Cycle 1
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点