Phase 3 Randomized Clinical Effectiveness Study Clinical and Safety of Filgrastine® in Patients With Breast Cancer Treated With Myelotoxic Chemotherapy
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- frequency of grade 4 neutropenia in the first cycle of chemotherapy in the group of patients treated with Filgrastine®
研究概览
简要总结
Randomized Study of the Clinical Efficacy and Safety of Filgrastine® in Patients with Breast Cancer Treated with Myelotoxic Chemotherapy.
Primary Objective: to evaluate the activity and safety of Filgrastine® in Brazilian patients undergoing adjuvant treatment for breast cancer, with the frequency of grade 4 neutropenia in the first cycle of chemotherapy as the primary endpoint.
Secondary Objectives:
- Frequency of febrile neutropenia during treatment;
- Frequency of neutropenia of any degree in the first cycle;
- Frequency of hospitalization during treatment;
- Duration of grade 4 neutropenia in the first treatment cycle;
- Toxicity during treatment;
- Immunogenicity throughout treatment.
All endpoints will be descriptively analyzed in both groups of patients.
Study design Randomized (2:1), open-label, multicenter study.
Chemotherapy will be given on the first day of each cycle of treatment, for a maximum of four to eight cycles, depending on the regimen, patients whose chemotherapy treatment is prolonged beyond this period being withdrawn from the study.
Patients will be evaluated through laboratory tests, including complete blood count, biochemistry and anti-filgrastim antibodies.
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
- •Provision of the Free and Informed Consent Form by written;
- •Female sex;
- •Age between 18 and 75 years old;
- •Diagnosis of breast cancer confirmed by cytology or histopathology;
- •Disease in stages II or III, according to the classification tumor-node-metastasis (TNM);
- •Indication of chemotherapy with full dose of one of the regimens eligible;
- •Performance status of 0 or 1;
- •Appropriate body functions (absolute neutrophil count [CAN] ≥1,500/mm³; platelet count ≥150,000/mm³; serum creatinine ≤1.2 mg/dL; bilirubin and transaminases ≤1.5 times the upper limit of normal).
排除标准
- •Previous use of chemotherapy;
- •Previous use of filgrastim;
- •Prediction of prophylactic or therapeutic use of antibiotics, antifungals or antivirals in the first cycle of chemotherapy;
- •Previous radiotherapy involving the pelvis or radiotherapy from any site within the last 6 weeks prior to randomization;
- •History of bone marrow transplantation (as a recipient);
- •Presence of other neoplasms;
- •Presence of severe co-morbidities;
- •Recent (<6 months) or planned participation in other studies clinical trials involving drugs of any nature or in studies of any form of intervention;
- •Known intolerance or allergy to any of the components the filgrastim formulations evaluated in the study;
- •Pregnancy or lactation (patients of childbearing potential must have a negative serological pregnancy test dated within 7 days prior to randomization).
结局指标
主要结局
frequency of grade 4 neutropenia in the first cycle of chemotherapy in the group of patients treated with Filgrastine®
时间窗: 1 month
次要结局
- Frequency of neutropenia of any degree in the first cycle;(1 month)
- Duration of grade 4 neutropenia in the first treatment cycle(1 month)
- Frequency of febrile neutropenia during treatment;(maximum 5 months)
- Adverse event monitoring(maximum 5 months)
- Frequency of hospitalization during treatment;(maximum 5 months)
- assessment of Immunogenicity throughout treatment by antigenic radiometric tests or ELISA(maximum 5 months)