Phase II, Open, Not Randomized Clinical Trial, to Evaluate the Sequential Taxotere®, Followed by Myocet® and Cyclophosphamide First Line Treatment in her2 Negative Breast Cancer Patients
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 83
- 试验地点
- 6
- 主要终点
- Determine proportion of Pathological complete responses
研究概览
简要总结
The purpose of this study is to determine how many pathological complete responses are achieved in patients treated with taxotere® (T) followed by Myocet® (M)and Cyclophosphamide (MC) first line treatment in HER2 negative brest cancer patients.
详细描述
Phase II, open, not randomized clinical trial, to evaluate the sequential Taxotere®, followed by Myocet® and Cyclophosphamide first line treatment in her2 negative breast cancer patients.
The purpose of this study is to determine how many pathological complete responses are achieved in patients treated with taxotere® (T) followed by Myocet® (M)and Cyclophosphamide (MC) first line treatment in HER2 negative brest cancer 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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Brest adenocarcinoma stages II/III
- •Informed consent signed
- •HER2 negative
- •Age>18 years old
- •ECOG < 1
- •Proper organic function regarding the following criteria:
- •ANC > 2,0 x 109L, platelets > 100 x 109L and hemoglobin > 10g/dL (transfusion is allowed)
- •Hepatic Function:
- •i.Bilirubin < 1,5 x UNL ii.AST ,ALT < 2,5 x UNL iii.Alkaline phosphatase < 5 UNL iv.Patients with AST and /or ALT > 1.5 x UNL and alkaline phosphatase > 2.5 x UNL will not be selected for the study c.Renal function: creatinine < 1,25 x UNL, or creatinine clearance > 60 mL/min d.Normal Cardiac function, confirmed with FEVI >50% and electrocardiogram.
- •Patients should be available for treatment and follow up and must be treated in investigator or co-investigator site
- •Negative pregnancy test(performed 7 days before treatment)
排除标准
- •Previous treatment for breast cancer (CT, RT, IT, HT)
- •Stages IIIb, IIIc or IV or invasive bilateral breast cancer
- •Previous neoplasias treated with Anthracyclines or Taxanes (Paclitaxel or Docetaxel)
- •Pregnant or breastfeeding females
- •Neurotoxicity Grade 2
- •FEV≤50% or any cardiac disease in which anthracyclines are contraindicated
- •Other severe diseases regarding investigator criteria
- •Any neurological or psychiatric pathology
- •Previous neoplasia different from breast cancer except:
- •skin cancer(no melanoma)
- •In situ cervix Carcinoma
- •Ipsilateral in situ ductal carcinoma
- •In situ lobular in situ carcinoma
- •Any other carcinoma without evidence disease in last 10 years
- •Treatment chronic with corticoids (except patients starting 6 months before inclusion with low dosages (* 20 mg methylprednisolone or equivalent)
- •Concomitant treatment with Hormone ovarian replacement therapy
- •Contraindication for corticoids
- •Concomitant treatment with another investigational drugs
- •Included in another clinical trial with any drug in 30 days before inclusion study
- •Concomitant treatment with another anticancer therapy
- •Male patients
- •Hypersensibility to any study drug or components
研究组 & 干预措施
Unique arm
4 cycles of Docetaxel 100mg/m2 iv followed by 4 cycles of Liposomal doxorubicine 60mg/m2/iv and Cyclophosphamide 600mg/m2/iv
干预措施: Docetaxel, Liposomal doxorubicine and Cyclophosphamide (Drug)
结局指标
主要结局
Determine proportion of Pathological complete responses
时间窗: At the end of the treatment, after Surgery.
次要结局
- Determine proportion of clinical responses(At the end of the treatment)
- Describe treatment safety(At the end of the treatment)
- Determine proportion of conservative breast surgery(At the end of the study)
- Evaluate disease free survival(At the end of the treatment)
- Evaluate Overall survival(At the end of the treatment)
- Evaluate gene patterns regarding prediction of treatment response(At the end of the treatment)