NCT01329640终止2 期
Phase II Feasibility Study of Weekly Paclitaxel Plus Weekly Trastuzumab Followed by Weekly Doxorubicin Plus Daily Oral Cyclophosphamide Plus Weekly Trastuzumab for Locally Advanced HER2-Positive Breast Cancer
Instituto do Cancer do Estado de São Paulo1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2010年9月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- INCIDENCE OF FEBRILE NEUTROPENIA
研究概览
简要总结
The purpose of this study is to evaluate the safety, effectiveness and cost-effectiveness of metronomic chemotherapy combined with trastuzumab as neoadjuvant therapy for locally advanced HER2-positive breast cancer.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of locally advanced breast cancer
- •T > 2 cm (any N), or any T and positive node(needle biopsy is required if tumor size is less than 2cm)
- •Non-metastatic disease confirmed by computerized tomography and bone scan
- •HER2 positive by IHC (+++) and/or Fish (+) according to international definitions (ASCO 2007)
- •Normal left ventricular ejection fraction (LVEF)
- •Indication of preoperative chemotherapy
- •multifocal tumors acceptable provided that the largest tumor is Her2-positive
排除标准
- •Another malignancy within the last 5 years (except curatively treated skin carcinoma, in situ cervix carcinoma, in situ ductal carcinoma of the breast, or in situ lobular carcinoma of the breast)
- •Clinically significant comorbidities such as cardiovascular diseases, COPD, renal or liver impairment, psychiatric disorders
- •LVEF value below institutional limits of normal range
- •Detected or suspected distant metastasis
- •Neutrophils lower than 1,500/µL, platelets lower than 100,000/µL, hemoglobin lower than 10 g/dL, AST higher than 2.5x upper limit of normal (ULN), total bilirubin higher than ULN, alkaline phosphatase more than 1.5x ULN
研究组 & 干预措施
Paclitaxel, trastuzumab, doxorrubicin, ciclophosphamide
Experimental
干预措施: Drug: Paclitaxel; trastuzumab; doxorrubicin; cyclophosphamide (Device)
结局指标
主要结局
INCIDENCE OF FEBRILE NEUTROPENIA
时间窗: 18 weeks
INCIDENCE OF FEBRILE NEUTROPENIA WITH METRONOMIC SCHEDULE WILL BE NO HIGHER THAN 10%
次要结局
- TUMOR SIZE(From the beginning of treatment until surgery, disease progression or death)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Taxol® in Monotherapy or in Combination With Topotecan or Carboplatin in Patients With Epithelial Ovarian Cancer in Early RelapseFallopian Tube CancerMalignant Tumor of PeritoneumOvarian CancerNCT00189566ARCAGY/ GINECO GROUP165
已完成
2 期
Early Phase II Study of Weekly Paclitaxel (BMS-181339) in Patient With Advanced or Recurrent Head and Neck CancerHead and Neck CancerNCT01024101Bristol-Myers Squibb36
已完成
2 期
Phase II Study of Weekly Paclitaxel (BMS-181339) in Patient With Non-Small Cell Lung Cancer (NSCLC)Non-Small Cell Lung CancerNCT01024062Bristol-Myers Squibb60
已完成
2 期
Phase II Study of Weekly Paclitaxel (BMS-181339) in Patient With Breast CancerBreast CancerNCT01023204Bristol-Myers Squibb68
撤回
2 期
Paclitaxel Plus Pembrolizumab vs. Paclitaxel Weekly in ER+ Luminal B Metastatic Breast CancerBreast CancerNCT03841747Queen Mary University of London