NCT00617968已完成2 期
A Multicenter, Randomized, Open-label, Phase II Study to Evaluate the Efficacy and Safety of Neoadjuvant Treatment Consisting of Either a Docetaxel - Letrozole Combination or Letrozole Alone in Women Over 60 Years of Age Suffering From Grade I or II Operable Hormone Receptor-positive Breast Tumor.
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Rate of clinical and radiological response evaluated according to RECIST criteria
研究概览
简要总结
Primarily to evaluate the rates of clinical and radiological response in the 2 groups. Secondarily rate of histological response.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients with breast cancer histologically proven by microbiopsy (14G or 16G) enabling confirmation of the diagnosis, and evaluation of the histological prognostic grade, hormonal receptors and HER2 status.
- •Tumor T2 or T3, non-metastasized, non-inflammatory, unilateral
- •Clinically or radiologically measurable lesion greater than 2 cm (ultrasound and/or mammogram)
- •Receptors RE+ and/or RP+ (positive status determined according to the criteria of the investigating centers)
- •HER 2 / neu status of 0, 1+ or 2+ in immunohistochemistry
- •Histological grade I or II
- •Menopausal patients aged greater than or equal to 60 years
- •Patients with ECOG PS greater than or equal to 2
- •Satisfactory hematological, hepatic and renal functions:
- •Hemoglobin greater than or equal to 10 g/dL
- •Platelet count greater than or equal to 100x109/L
- •Polynuclear neutrophil count greater than 1.5x109/L
- •Creatinine less than or equal to ≤ 1.5 ULN
- •AST/ALT less than or equal to 1.5 ULN
- •Alkaline phosphatases less than or equal to 2.5 ULN
- •Patients able to be followed throughout the study
- •Patient's consent obtained.
排除标准
- •Inflammatory or T4 breast cancer
- •Patients whose tumor is deemed by the doctor to be difficult to evaluate
- •Tumor that is metastatic from the outset (M1) or locally advanced and inoperable from the outset
- •RE and RP receptors negative or unknown
- •HER 2/neu positive at 3 +
- •Non-menopausal patients
- •Surgical biopsy and/or ganglion dissection before neoadjuvant treatment
- •Significant poorly controlled cardiac disorders, such as unstable angina pectoris, poorly controlled heart failure, arrhythmia requiring treatment, or myocardial infarction within the last 3 months
- •Cardiovascular, hepatic, neurological or endocrine disease, or other major systemic disease that makes it difficult to conduct the protocol or to interpret the results
- •Previous history of cancer that occurred within the last 10 years, with the exception of cervical cancers and basocellular skin cancers that were properly treated
- •Allergy to polysorbate 80
- •Hypersensitivity to docetaxel
- •Participation in another clinical trial with one of the study medicinal products during the 30 days prior to entry in the study
- •Patients who are unable to undergo medical monitoring for geographical, social or psychological reasons
结局指标
主要结局
Rate of clinical and radiological response evaluated according to RECIST criteria
时间窗: During the study conduct
次要结局
- Rate of histological response(During the study conduct)
研究者
研究点 (1)
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