Phase II Study of Dose Dense Carboplatin and Taxotere With Herceptin As Primary Systemic Therapy in Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Number of Patients With Pathologic Complete Response (pCR)
研究概览
简要总结
Dose dense therapy has been shown to increase survival in the adjuvant setting of breast cancer. It is unknown if dose dense therapy will improve survival in tumors that express her-2. This study evaluates a neoadjuvant regimen containing carboplatin, taxotere and herceptin when used in a dose dense manner in patients with large breast cancers. The endpoint of pathologic complete response is used as a surrogate marker for survival.
详细描述
Dose dense therapy has been shown to increase survival in the adjuvant setting of breast cancer. It is unknown if dose dense therapy will improve survival in tumors that express her-2. This study evaluates a neoadjuvant regimen containing carboplatin, taxotere and herceptin when used in a dose dense manner in patients with large breast cancers. The endpoint of pathologic complete response is used as a surrogate marker for survival.Safety and tolerability assessed by number of grade 4 toxicities and hospitalizations
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •HER-2 overexpressing breast cancer
- •Clinical stage 2-3B
- •Normal ejection fraction
排除标准
- •Metastatic disease
- •Low ejection fraction
研究组 & 干预措施
arm 1
single arm study evaluating the efficacy of neoadjuvant taxotere, herceptin and carboplatin given in a dose dense fashion
干预措施: trastuzumab, docetaxel and carboplatin in dose dense regimen (Drug)
结局指标
主要结局
Number of Patients With Pathologic Complete Response (pCR)
时间窗: determined at the time of surgery which is approximately 16 weeks from the beginning of treatment
pCR is defined as the absence of invasive tumor from the surgical specimen of breast and axilla which is obtained after the chemotherapy regimen has been delivered.
次要结局
- Safety and Tolerability(from the first dose of chemotherapy until surgery which was approximately 16 weeks.)