Phase II Study of Neoadjuvant Pegylated Liposomal Doxorubicin and Docetaxel in Locally Advanced Operable Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Pathological Complete Response
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving them before surgery may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects of giving liposomal doxorubicin together with docetaxel before surgery and to see how well it works in treating women with locally advanced breast cancer that can be removed by surgery.
详细描述
OBJECTIVES:
Primary
- To evaluate the rate of pathological complete response and clinical complete response in women with locally advanced breast cancer treated with pegylated doxorubicin hydrochloride liposome and docetaxel.
Secondary
- To assess the overall clinical local regional response in patients treated with this preoperative chemotherapy regimen.
- To evaluate the number of patients who would have required a mastectomy upfront but who underwent breast conservation therapy instead after neoadjuvant chemotherapy.
- To assess the safety, particularly with regard to neutropenia and cardiac toxicity, of pegylated doxorubicin hydrochloride liposome and docetaxel.
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
入排标准
- 年龄范围
- — 至 64 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Pathological Complete Response
时间窗: Mammogram done pre-treatment and after four and six cycles of study chemotherapy treatment.
Clinical Complete Response
时间窗: Surgery done after completion of six cycles of study chemotherapy treatment.
次要结局
- Safety, in Terms of Neutropenia and Cardiac Toxicity(Every cycle during study treatment and 8 weeks post-treatment.)
- Overall Clinical Local Regional Response(Mammogram done pre-treatment and after four and six cycles of study chemotherapy treatment.)
- Number of Women Who Would Have Required a Mastectomy Upfront But Who Underwent Breast Conservation Therapy Instead After Neoadjuvant Chemotherapy(Baseline (pre-treatment) surgical assessment, and post-chemotherapy surgical outcome.)