NCT00518583Unknown2 期
A Phase II Study of Pre-Operative Pegylated Liposomal Doxorubicin (PLD), Paclitaxel, and Trastuzumab in Patients With Operable Breast Cancer Over-expressing Her2-neu
Aptium Oncology Research Network18 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2006年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 18
- 主要终点
- Identify the pCR rate of neoadjuvant chemotherapy using the proposed 18-week regimen of PLD + paclitaxel + trastuzumab
研究概览
简要总结
The study will evaluate the safety and efficacy of the combination PLD, paclitaxel, and trastuzumab in patients with operable breast cancer. Patients will be treated with the combination for 18 weeks, followed by surgery.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Dx of clinical T1c-T3, N0-1, M0 breast cancer
- •Interval between diagnosis and consent of <- 62 days
- •Life expectancy of 10 years
- •LVEF by MUGA >= lower limit of normal for the testing facility
- •Negative serum pregnancy test
- •Adequate bone marrow, renal, liver function
- •Negative bone scan
- •HRT discontinued before study entry
- •Adequate contraceptive methods
排除标准
- •Male breast cancer
- •Less than 21 years of age
- •Ulceration, infiltration of the skin, complete fixation or severe skin edema
- •N3 disease in which nodes are matted and fixed
- •Suspicious palpable supraclavicular nodes
- •CT evidence of malignant internal mammary nodes
- •Pregnancy or breast feeding at time of study entry
- •Prior therapy for breast cancer
- •Prior anthracycline for any malignancy
- •Prior breast malignancy of the contralateral breast
- •Prior non-breast malignancy within 5 years
- •Non-malignant disease that would preclude follow up
- •MI within 6 months, NYHA Class II or greater heart failure
- •Psychiatric disorders or conditions that would preclude provision of informed consent
结局指标
主要结局
Identify the pCR rate of neoadjuvant chemotherapy using the proposed 18-week regimen of PLD + paclitaxel + trastuzumab
时间窗: within 18 weeks
次要结局
- Identify the complete response rate(within 18 weeks)
- Identify the partial response rate(within 18 weeks)
- Identify the overall response rate(within 18 weeks)
- Evaluate changes in cardiac function(within study participation)
- Monitor safety and tolerability of neoadjuvant chemotherapy using the proposed 18 week regimen(within study participation)
研究者
研究点 (18)
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