Phase II Trial of Herceptin Concurrent With External Beam Radiation Following Neoadjuvant Chemotherapy for the Treatment of HER2 Over-Expressing Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 19
- 主要终点
- Number of subjects experiencing adverse events
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy x-rays to kill tumor cells. Trastuzumab may make tumor cells more sensitive to radiation therapy. Giving trastuzumab together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects and how well giving trastuzumab together with external beam radiation therapy works in treating women with stage III or stage IV breast cancer.
详细描述
OBJECTIVES:
Primary
- Determine the tolerability of trastuzumab (Herceptin®) and concurrent external beam radiotherapy in women with HER2-overexpressing stage III or IV breast cancer.
Secondary
- Determine the pathologic response rate in patients treated with this regimen.
- Determine the locoregional recurrence rate (as site of first recurrence or any recurrence) and time to locoregional recurrence in patients treated with this regimen.
- Determine the time to local progression in patients (who are deemed to be non-surgical candidates) treated with this regimen .
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Surgical Candidate
After 5 consecutive weeks of treatment with Radiation and Herceptin, these subjects will receive mastectomy excision
干预措施: external beam radiation therapy (Radiation)
Surgical Candidate
After 5 consecutive weeks of treatment with Radiation and Herceptin, these subjects will receive mastectomy excision
干预措施: Herceptin (Drug)
Non-Surgical Candidate
After 5 weeks of consecutive treatment with radiation and herceptin, these subjects will not be eligible for surgery. They will continue with radiation and herceptin for an additional 2 weeks.
干预措施: external beam radiation therapy (Radiation)
Non-Surgical Candidate
After 5 weeks of consecutive treatment with radiation and herceptin, these subjects will not be eligible for surgery. They will continue with radiation and herceptin for an additional 2 weeks.
干预措施: Herceptin (Drug)
结局指标
主要结局
Number of subjects experiencing adverse events
时间窗: 7 weeks
Toxicity (adverse events) will be measured and graded using the CTCAE criteria. RTOG acute toxicity criteria will be used to score acute radiation-related toxicity
次要结局
- Pathologic response rate(5 weeks)
- Locoregional recurrence rate(up to 5 years)
- Time to locoregional recurrence(Up to 5 years)
- Time to local progression (in patients who are deemed to be non-surgical candidates)(Up to 5 years)