Phase IV/II Trial With the Combination of Pegylated Liposomal Doxorubicin (Caelyx), Cyclophosphamide and Trastuzumab in Patients With Metastatic Breast Cancer With Overexpression of Human Epidermal Growth Factor Receptor 2 (HER2)/Neu
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 12
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
Eligible patients must receive Caelyx plus Cyclophosphamide plus Herceptin for 6 cycles that will be administered every 4 weeks.
详细描述
Sample size calculation will be done by means of Simon's method in 2 stages for phase II studies and will be based on the principal aim of the study (evaluation of the rate of objective response).
The hypothesis brings over of the efficiency of the treatment it will be accepted if a rate of objective response of at least 55 % is obtained, rejecting the efficiency of the treatment when the rate of response targets be lower than 35 %. In this case, considering an alpha error of 0.05 and 80 % power, 14 patients will be included in the first stage; the study would continue if more than 5 objective responses were found. The total number of patients to including in the study would be 44. The results will be significant if they find at least 20 objective responses.
Assuming a drop-out rate of 10 %, the total number of patients needed is 49 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patients must sign an informed consent before of specific procedures of clinical trial.
- •Patients with histologically confirmed breast cancer and overexpression of Her2neu.
- •Age> 18 years.
- •Eastern Cooperative Oncology Group (ECOG) equal or <
- •Patients have not been treated previously with chemotherapy for metastatic disease.
- •Patients must have at least one measurable lesion according to RECIST criteria.
- •Patients should have an adequate organ function to tolerate chemotherapy.
排除标准
- •Patients with hypersensitivity reactions to any of the medications of the clinical trial.
- •Patients who are pregnant or lactating are not eligible.
- •Hepatic disease.
- •Not controlled active infection
- •Symptomatic metastatic brain cancer
- •Previous adjuvant treatment with anthracyclines with a total accumulated dose > 300 mg/m2 (Doxorubicin) or > 600 mg/m2 (Epirubicin)
研究组 & 干预措施
Caelyx,Cyclophosphamide,Trastuzumab
Caelyx (Liposomal Doxorubicin) 50 mg/m2 every 4 weeks for 6 cycles, Cyclophosphamide 600 mg/m2 every 4 weeks for 6 cycles, Trastuzumab weekly for 24 weeks, at dose of 2mg/kg (day 1 loading dose of 4mg/kg)
干预措施: Liposomal Doxorubicin (Drug)
Caelyx,Cyclophosphamide,Trastuzumab
Caelyx (Liposomal Doxorubicin) 50 mg/m2 every 4 weeks for 6 cycles, Cyclophosphamide 600 mg/m2 every 4 weeks for 6 cycles, Trastuzumab weekly for 24 weeks, at dose of 2mg/kg (day 1 loading dose of 4mg/kg)
干预措施: Cyclophosphamide (Drug)
Caelyx,Cyclophosphamide,Trastuzumab
Caelyx (Liposomal Doxorubicin) 50 mg/m2 every 4 weeks for 6 cycles, Cyclophosphamide 600 mg/m2 every 4 weeks for 6 cycles, Trastuzumab weekly for 24 weeks, at dose of 2mg/kg (day 1 loading dose of 4mg/kg)
干预措施: Trastuzumab (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: Up to cycle 6 (24 weeks)
ORR is the sum of the Complete Responses (CR) and Partial Responses (PR) according to the RECIST criteria, experienced for each patient during treatment (recorded from the start of the treatment until disease progression). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan (computed tomography) or MRI (magnetic resonance imaging): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response Rate (ORR) = CR + PR.
次要结局
- Response Duration(Through study treatment, and follow up period, assessed up to 88 weeks)
- Overall Survival (OS)(Through study treatment, and follow up period, assessed up to 88 weeks)
- Time to Progression (TTP)(Through study treatment, and follow up period, assessed up to 88 weeks)
- Time to Treatment Failure (TTF)(Through study treatment, and follow up period, assessed up to 88 weeks)