NCT00461344终止2 期
A Multicenter, Open Label, Phase II Trial Evaluating Docetaxel + Anthracycline x 4 Cycles Followed by Docetaxel Single Agent x 4 Cycles as First-Line Therapy in Patients With Her2 Negative Locally Advanced or Metastatic Breast Cancer Who Have Relapsed ≥ 12 Months From Completion of Neoadjuvant/Adjuvant Taxotere®- Based Chemotherapy
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 20
- 主要终点
- Primary 1. to determine the pathological remission following the chemotherapy combination docetaxel and doxorubicin in large breast cancer
研究概览
简要总结
Primary: To determine the pathological remission following the chemotherapy combination docetaxel and doxorubicin in large breast cancer
Secondary:
- Clinical response rate
- To investigate the safety of docetaxel doxorubicin combination in the treatment for neoadjuvant chemotherapy of breast cancer
- Type of surgery (radical/conservative)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Histologically verified breast cancer
- •Large (≥ 3 cm) breast cancer
- •IIb-IIIa stage
- •ECOG (Eastern Cooperative Oncology Group) status: 0-1-2
- •Adequate bone marrow reserve: (Haemoglobin ≥ 12g/l, Absolute Neutrophil Count (ANC) ≥ 2.0x 10^9, Platelets ≥100 000)
- •Laboratory results:
- •Bilirubin ≤ Upper Limit Normal (ULN)
- •Serum Glutamate Pyruvate Transaminase (SGPT) ≤ 2.5 ULN, Serum Glutamate Oxaloacetate Transaminase (SGOT) ≤ 2.5 ULN,
- •Alk.phosph. ≤ 5.0 ULN,
- •Creatinin ≤ ULN, if borderline calculated at ≤ 60ml/min
- •Normal cardiac function (the result of Left Ventricular Ejection Function (LVEF) must be above the lower limit of normal for the institution)
- •Negative pregnancy test
- •Hormonal receptor status assessed
排除标准
- •Pregnancy or lactation
- •SGOT and/or SGPT > 1.5 upper limit normal, associated with Alk.phosph > 2.5 ULN
- •Serious medical condition including but not limited to:
- •Uncontrolled hypertension
- •Active ulcus pepticum
- •Non-stable diabetes mellitus
- •Other contraindication of steroid treatment
- •Myocardial infarction within the last 6 months prior study entry
- •Significant neurologic/psychiatric disorders
- •Active infection
- •Peripheral neuropathy grade ≥ 2
- •Unstable angina
- •Severe arrhythmia
- •Participation in other clinical trial
- •Prior surgery, chemotherapy, hormonotherapy for breast cancer
- •Past or current history of neoplasm other than breast cancer, except for: curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix, other cancer curatively treated and with no evidence of disease for at least 7 years
- •History of hypersensitivity to the investigational products or to drugs with similar chemical structures
- •Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol
- •Treatment with any investigational product in the last 1 month before study entry.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
结局指标
主要结局
Primary 1. to determine the pathological remission following the chemotherapy combination docetaxel and doxorubicin in large breast cancer
次要结局
- Secondary: 1. Clinical response rate 2. to investigate the safety of docetaxel doxorubicin combination in the treatment for neoadjuvant chemotherapy of breast cancer 3. Type of surgery (radical/conservative)
研究者
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