Stereotactic Body Radiation Therapy (SBRT) to Extend the Benefit of Systemic Therapy in Patients With Solitary Disease Progression
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 46
- 试验地点
- 16
- 主要终点
- Progression free survival
研究概览
简要总结
The purpose of this study is to see if using Stereotactic Body Radiation Therapy/SBRT to treat a single metastatic site where cancer has worsened may be an effective treatment for people with oligometastatic breast cancer. Participants will stay on their usual drug therapy while they receive SBRT. This combination of SBRT to a single metastatic site and usual drug therapy may prevent participants' cancer from worsening in other metastatic sites or spreading.
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
- •Age 18 or older
- •Willing and able to provide informed consent
- •Metastatic breast cancer, biopsy proven
- •ER+/HER2-, defined as >5% ER+ staining
- •HER2+ (regardless of ER status), including HER2-low and high expressors
- •History of at least 6 months, sustained response to systemic therapy (clinically or radiographically defined as complete or stable response without progression)
- •Isolated site of disease progression on FDG PET scan
- •Consented to 12-245
- •ECOG performance status 0-1
排除标准
- •Pregnancy
- •Serious medical comorbidity precluding radiation, including connective tissue disorders
- •Intracranial disease (including previous intracranial involvement)
- •Previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances.
研究组 & 干预措施
Participants with oligometastatic breast cancer
Participants with oligometastatic breast cancer with isolated progression after sustained (>=6 month) response to systemic therapy. Participants will receive image guided, SBRT to the progressive lesion identified on imaging. Participants will be maintained on their existing line of systemic therapy. Systemic therapy will be held during days of radiation and resume following completion of radiation.
干预措施: Stereotactic body radiotherapy (Radiation)
结局指标
主要结局
Progression free survival
时间窗: 3 months from start of SBRT delivery
The primary objective is to assess progression free survival, defined as systemic progression or death, within 3 months from start of Stereotactic Body Radiation Therapy/SBRT delivery.
次要结局
未报告次要终点