A Phase I Dose-Escalation Study of Cisplatin and Radiation Therapy for Patients With Triple Negative Breast Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 5
- 主要终点
- Safety of Cisplatin w/ Radiation
研究概览
简要总结
This is a Phase I dose escalation study of cisplatin and concurrent radiation in patients with ER negative, PR negative and HER2 negative breast cancer who have undergone breast-conserving surgery or mastectomy.
Primary objective: To assess the safety, tolerability, and maximum tolerated dose (MTD) of cisplatin when given concurrently with radiation therapy for participants with Stage II or III breast cancer who have undergone breast conserving surgery or mastectomy
详细描述
This is a phase I dose escalation study of cisplatin and radiation to determine the toxicity of this combined treatment and establish an MTD.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Primary tumor is triple negative breast cancer
- •Breast-conserving surgery or mastectomy with surgical excision of all gross disease with negative surgical margins
- •Pathologic or clinical stage II or III disease
- •At least 3 week interval from last chemotherapy administration/breast surgery to radiation (no more than 8 weeks)
排除标准
- •Pregnant or breastfeeding
- •Prior radiation to breast or ipsilateral regional nodes
- •Ongoing therapy with other investigational agents
- •Hormonal therapy
- •Significant co-morbidity
- •Pathologic complete response following preoperative chemotherapy
- •Biopsy proven metastatic disease
研究组 & 干预措施
Cisplatin + Radiation Therapy
Cisplatin concurrently with radiation therapy
干预措施: Radiation Therapy (Radiation)
Cisplatin + Radiation Therapy
Cisplatin concurrently with radiation therapy
干预措施: Cisplatin (Drug)
结局指标
主要结局
Safety of Cisplatin w/ Radiation
时间窗: 2 years
To determine the maximum tolerated dose of cisplatin when given concurrently with radiation therapy for participants with Stage II or III breast cancer who have undergone breast conserving surgery or mastectomy.
次要结局
- Local recurrence at 5 years(5 years)
- Long term toxicity(2 years)
研究者
Jennifer Bellon
Principal Invstigator
Dana-Farber Cancer Institute