Injection Regimen Trial of Pegylated Recombinant Human Granulocyte Colony Stimulating Factor (PEG-rhG-CSF) in Preventing Bone Marrow Suppression and/or Febrile Neutropenia (FN) During Breast Cancer Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- the rates of grade III/IV neutropenia during the first and second chemotherapy cycle
研究概览
简要总结
The purpose of this study is to try to find a better injection regimen (including time and dose) of PEG-rhG-CSF, which is supposed to better prevent bone marrow suppression and/or FN in breast cancer patients who receive chemotherapy.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Received systemic or local treatment for tumors, including chemotherapy, radiotherapy, and endocrine therapy.
- •A history of malignant tumors within 5 years (except curable skin basal cell carcinoma and cervical carcinoma in situ).
- •The patient has been enrolled in other clinical trials or used other study drugs 30 days before enrollment in this study.
- •Accompanied by uncontrolled lung disease, severe infection, active gastrointestinal ulcer need treatment, coagulopathy, severe uncontrolled diabetes, connective tissue disease or bone marrow function suppression, and other diseases, can not tolerate chemotherapy-related treatments.
- •Two-dimensional echocardiography detection LVEF <55%.
- •Severe cardiovascular and cerebrovascular diseases within the first 6 months of randomization (eg unstable angina, chronic heart failure, uncontrollable hypertension> 150/90 mmHg, myocardial infarction, or cerebrovascular accident).
- •NCI peripheral neurotoxicity grade ≥
- •Those taking glucocorticoids.
- •Known hypersensitivity to anthracyclines, cyclophosphamide, taxanes, trastuzumab, or pertuzumab.
- •Refuse contraception during treatment and within 8 weeks after completion of treatment for women of childbearing age.
- •Pregnant and lactating women.
- •After joining the test, a pregnancy test (+) before using the drug.
- •There are mental illness, cognitive impairment, unable to understand the test plan and side effects, unable to complete the test plan, and follow-up workers (systematic evaluation is required before the trial is enrolled).
- •No personal freedom and independent civil capacity.
- •The investigator determined that the patient could not obtain long-term follow-up data (due to unavailability or serious concomitant diseases).
研究组 & 干预措施
Experimental: Experimental/PEG-rhG-CSF
patients received a single dose of 6mg of PEG-rhG-CSF(pegfilgrastim), as a single subcutaneous injection on day 7 (chemotherapy day was recorded as day 1). If WBC >= 15 x 10^9/L in the first chemotherapy cycle, then 3mg PEG-rhG-CSF will be used in the second chemotherapy cycle.
干预措施: Day 7 regimen (Drug)
Comparator: Comparator/PEG-rhG-CSF
patients received a single dose of 6mg of PEG-rhG-CSF(pegfilgrastim), as a single subcutaneous injection on day 3 (chemotherapy day was recorded as day 1). If WBC >= 15 x 10^9/L in the first chemotherapy cycle, then 3mg PEG-rhG-CSF will be used in the second chemotherapy cycle.
干预措施: Day 3 regimen (Drug)
结局指标
主要结局
the rates of grade III/IV neutropenia during the first and second chemotherapy cycle
时间窗: up to 9 weeks
grade III or IV neutropenia (ANC \< 1x 10\^9/L or 0.5 x 10\^9/L)
the rates of FN during the first and second chemotherapy cycle
时间窗: up to 9 weeks
the occurrent rate of FN（FN：Body temperature ≥38.3°C or ≥38.0°C continued for 1 h, with neutrophil count \<500/mcl or neutrophil count \<1000/mcl, but expected to drop to \<500/ mcl after 48 hours .）
次要结局
- Proportion of patients with down-regulated dosage of PEG-rhG-CSF from 6mg to 3mg(up to 9 weeks)
- Adverse reactions after injection of PEG-rhG-CSF during first and second chemotherapy cycle(up to 9 weeks)
研究者
Jue Wang
Prof.
The First Affiliated Hospital with Nanjing Medical University