Reducing Neutropenia Incidence by Changing the Date of Eflapegrastim Administration in Breast Cancer Patients Who Have Experienced Neutropenia After Chemotherapy
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence rate of severe neutropenia Incidence rate of severe neutropenia
研究概览
简要总结
Patients who experienced neutropenia after receiving pegfilgrastim on day 1 of the first round are randomly assigned to either the control or experimental arm. Patients in the control arm continue pegfilgrastim injection on day 1 while patients in the experimental arm will receive pegfilgrastim injection on day 3 to see if changing the pegfilgrastim administration date from day 1 to day 3 starting from the second round of chemotherapy could reduce the incidence of neutropenia
详细描述
The use of pegfilgrastim, which has a long-lasting effect in the human body, after myelosuppressive chemotherapy for solid tumors, including breast cancer, and blood cancers has led to a decrease in the incidence of neutropenia, including febrile neutropenia, and a reduction in medical costs by shortening hospitalization periods related to side effects of chemotherapy. During the early stages of drug development, there was controversy over the timing of pegfilgrastim administration, and attempts were made to administer it at various times, from the day of chemotherapy to the day of neutropenia began. However, based on several studies, it is now known that patients who receive pegfilgrastim on the day of chemotherapy or after 4 days of chemotherapy have a higher incidence of febrile neutropenia. Therefore, administering pegfilgrastim on day 1-3 after chemotherapy is ideal, but in reality, it is often difficult for patients to visit the hospital multiple times after chemotherapy, so many patients are discharged after receiving pegfilgrastim on day 1. The FDA and National Comprehensive Cancer Network (NCCN) guidelines also recommend administration on day 1. It is known that patients who experience neutropenia after the first round of chemotherapy are more likely to experience it again in subsequent rounds. The investigators aimed to see whether changing the pegfilgrastim administration date from day 1 to day 3 starting from the second round of chemotherapy for patients who experienced neutropenia after receiving pegfilgrastim on day 1 of the first round can reduce the incidence of neutropenia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18 to 75 years old as of the date of study registration.
- •Patients with histologically confirmed invasive adenocarcinoma.
- •Patients with confirmed estrogen receptor, progesterone receptor, and Her2 receptor status.
- •Patients with Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •Patients with a left ventricular ejection fraction (LVEF) ≥55%.
- •Patients who have agreed to participate in this trial and have provided written consent.
排除标准
- •Patients with a history of breast cancer treatment
- •Patients with a history of chemotherapy, radiation therapy, immunotherapy, or biotherapy for malignancies other than breast cancer
- •Patients with infectious diseases
- •Patients with serious illnesses that may affect this clinical trial: cardiovascular disease, kidney disease, liver disease, endocrine disease, tumors, or diabetes
- •Other individuals deemed by the clinical trial investigators to be unable to participate in the trial.
研究组 & 干预措施
Day1 Group
Eflapegrastim administration on day 1 (24 hours after completion of chemotherapy)
干预措施: Eflapegrastim (Drug)
Day 3 Group
Eflapegrastim administration on day 3 (the third day after completion of chemotherapy
干预措施: Eflapegrastim (Drug)
结局指标
主要结局
Incidence rate of severe neutropenia Incidence rate of severe neutropenia
时间窗: cycle 2-5 (21 days for each cycle), 105 days
The incidence rates of Grade 4 neutropenia (ANC \< 500 respectively)
次要结局
- Duration of severe neutropenia(cycle 2-5 (21 days for each cycle), 105 days)
- Incidence rate of febrile neutropenia(cycle 2-5 (21 days for each cycle), 105 days)
- Incidence rate of neutropenia related death(1 year)
研究者
Changwan Jeon
Chief of Breast Center
Eunseong Medical Foundation Good GANG-AN HOSPITAL
