A Prospective Phase II Study of Radiation Therapy to Treat Refractory Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
For locally advanced or recurrent metastatic breast cancer that is resistant to systemic therapy, radiotherapy (RT) may be considered as the preferred treatment option when the lesion is unresectable, or the patient is not suitable for surgery. This study aim to evelatuate the local control of radical dose RT or new RT technique (such as patially fractionated radiation therapy, SFRT) for the locally advanced or recurrent metastatic breast cancer.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
- •Locally advanced or recurrent metastatic breast cancer, pathologically confirmed;
- •At least one extracranial measurable lesion suitable for radiotherapy;
- •Signature of informed consent form.
排除标准
- •Pregnant or lactation women;
- •Severe concomitant conditions, including persistent or active infections, symptomatic congestive heart failure, unstable angina pectoris, and serious arrhythmias et al.
研究组 & 干预措施
Radiotherapy
Radical dose is delivered for the patients. . SFRT is recommended for the patients with bulky tumor (such as ≥ 5cm). SFRT is delivered with 12-20Gy (1 fraction) followed by EBRT with EQD2≥60Gy.
干预措施: Radical dose radiotherapy (Radiation)
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: 3 months
次要结局
- Overall Response Rate (ORR)(1 month)
- Local control(1 year)
- Progression-Free Survival (PFS)(1 year)
- Overall Survival (OS)(1 year)
- Number of participants with treatment-related acute and late adverse events as assessed by CTCAE v5.0(1 year)
研究者
Shulian Wang,MD
Chief Physician
Cancer Institute and Hospital, Chinese Academy of Medical Sciences