A Phase II Study of Neoadjuvant Treatment With Pegylated Liposomal Doxorubicin (Caelyx) and Cyclophosphamide +/- Trastuzumab Followed by Docetaxel in Patients With Locally Advanced Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 7
- 主要终点
- clinical response rate
研究概览
简要总结
The purpose of this study is to determine the efficacy of neoadjuvant treatment with pegylated liposomal doxorubicin (Caelyx) and cyclophosphamide +/- trastuzumab followed by docetaxel in patients with locally advanced, inflammatory breast cancer or with a primary tumor > 5 cm.
详细描述
Patients with locally advanced or inflammatory breast cancer have a very bad prognosis. Several studies have shown that patients who receive a pathological complete response have the best prognosis. Neoadjuvant chemotherapy including anthracyclines and taxanes has become established as a standard option in the multidisciplinary management of this group of patients. In HER2 positive patients, chemotherapy in combination with trastuzumab is therapeutically attractive. Recent studies have also demonstrated that evaluation with PET-CT scan can be used to stratify treatment and monitor early response to neoadjuvant therapy.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •pathologically proven breast cancer
- •inflammatory, locally advanced breast cancer or a tumor > 5 cm
- •ECOG performance status < 2
- •LVEF > 50% measured by MUGA (HER2 positive patients)
- •adequate bone marrow, liver and renal function
- •written informed consent must be obtained
排除标准
- •another malignancy within 5 years prior to study entry
- •concurrent treatment with an investigational agent
- •other disease or condition that contraindicates participation in the study
- •pregnant or lactating females
结局指标
主要结局
clinical response rate
时间窗: 24 weeks
evaluation of treatment efficacy every 2.cycle
次要结局
- pathological response rate, response rate as defined by PET-CT scan, mammography and ultrasound, evaluation of toxicity of the combination regimen(up to 30 weeks)