NCT02142010Unknown不适用
Weekly Paclitaxel Liposome Injection Plus Cisplatin in Preoperative Treatment of Breast Cancer
Nanjing Luye Sike Pharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 67 人开始时间: 2014年8月最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- pathological complete remission (pCR) rate
研究概览
简要总结
The purpose of this study is to evaluate the pathological complete response (pCR) rate in breast cancer patients treated with weekly paclitaxel liposome injection plus cisplatin preoperative regimen.
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged ≥ 18 years and < 65 years,An estimated life expectancy of at least 12 months
- •At least one measurable disease according to the RECIST. histologically confirmed invasive breast cancer, stage II and III, no prior systemic or loco-regional treatment of breast cancer
- •Biopsy specimens are available for ER, PgR and Her2 analysis
- •Adequate bone marrow function: Neutrophil ≥ 1.5*109/L; Hb ≥ 100g/L; PLT ≥ 100*109/L
- •adequate liver function (bilirubin > 1.0 times upper normal limit [UNL] and ALT and/or AST> 1.5 UNL associated with alkaline phosphatase > 2.5 UNL;
- •Women with potential child-bearing must have a negative pregnancy test (urine or serum) within 7 days of drug administration and agree to use an acceptable method of birth control to avoid pregnancy for the duration of the study
- •No obvious main organs dysfunction
- •patients must be accessible for treatment and follow-up and written informed consent
排除标准
- •Patient is pregnant or breast feeding
- •Inflammatory breast cancer and Metastatic breast cancer
- •Patients with medical conditions that indicate intolerant to neoadjuvant therapy and related treatment, including uncontrolled pulmonary disease, diabetes mellitis, severe infection, active peptic ulcer, coagulation disorder, connective tissue disease or myelo-suppressive disease
- •History of congestive heart failure, uncontrolled or symptomatic angina pectoris, arrhythmia or myocardial infarction; poorly controlled hypertension (systolic BP > 180 mmHg or diastolic BP > 100 mmHg)
- •Has peripheral neuropathy
- •Treatment with any investigational drugs within 30 days before the beginning of study treatment
- •No psychiatric illness and other situations that would limit compliance of study
- •With a history of other malignant tumor
- •Known severe hypersensitivity to any drugs in this study
研究组 & 干预措施
paclitaxel liposome injection plus cisplatin
Other
干预措施: paclitaxel liposome injection plus cisplatin (Drug)
结局指标
主要结局
pathological complete remission (pCR) rate
时间窗: after 4 months of preoperative treatment
次要结局
- clinical response rate(after 4 months of preoperative therapy)
- Adverse Events as a Measure of Safety and Tolerability(4 months during neoadjuvant therapy)
研究者
研究点 (1)
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