STereotactic Body Radiotherapy (SBRT) After oligoprogRession Metastatic Breast Cancer (STAR-B)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 主要终点
- Percentage of patients with change in systemic therapy
研究概览
简要总结
Recent advances in systemic therapy have facilitated improved progression-free survival (PFS) and treatment tolerability in metastatic breast cancer patients (MBC). Oligoprogression (OP) refers to progression limited to five or fewer sites in otherwise controlled systemic disease on a drug therapy. Stereotactic body radiotherapy (SBRT) has the potential to locally ablate resistant OP lesions that develop on a systemic treatment, and may consequently delay the need for change in drug therapy, delay time to chemotherapy and prolong PFS. This is a phase II trial of SBRT plus continuation of current systemic therapy line for OP MBC patients, to determine rate of delay of change in systemic therapy of at six months. PFS, time to chemotherapy and quality of life will also be assessed.
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
- •Diagnosis of progressive metastatic breast cancer on first line systemic therapy, including either hormone receptor positive, Her-2 negative (HR+/Her2-) on endocrine therapy + CDK4/6 inhibitor or Her-2 positive (hormone receptor positive or negative /Her2+) on Her2-targeted therapy regimens.
- •Progressive disease limited to "oligoprogression", defined as progression of 5 or fewer extra-cranial lesions with otherwise controlled systemic disease on current line of systemic therapy.
- •Patients must have previously controlled disease for at least six months on current systemic therapy
- •Deemed a candidate for stereotactic body radiotherapy (SBRT) to all OP lesions
排除标准
- •Requires change in systemic therapy line at the time of OP as determined by medical oncologist;
- •Progression on 2nd line or subsequent lines of therapy
- •Lacks CT or bone scan Imaging within previous 45 days;
- •Progression in >3 sites in the liver or lung;
- •Hormone positive disease on endocrine therapy only at time of enrollment;
- •Previous radiotherapy to same site or vicinity preventing definitive SBRT (e.g. within 5 cm);
- •Lesions deemed not amenable to SBRT due to large size or location;
- •Unacceptable fracture risk according to clinician judgement for bone lesions;
- •Brain metastasis or Spinal cord compression;
- •History of major radiosensitivity syndrome or contraindications to radiotherapy.
结局指标
主要结局
Percentage of patients with change in systemic therapy
时间窗: Six months
Change in systemic therapy will occur with progression with the following criteria: 1. Progression not amenable to further SBRT, including multifocal (\>3) sites; 2. Progression in lesion not amenable to further SBRT; 3. Rapid progression such that treating medical oncologist believes change in therapy is warranted; 4. Progression in location including, including visceral metastasis, such that treating medical oncologist believes change in therapy is warranted
次要结局
- Time to chemotherapy(3, 6, 12, 18, and 24 months)
- Progression-free survival(3, 6, 12, 18, and 24 months)
- Local progression(3, 6, 12, 18, and 24 months)
- Overall Survival(3, 6, 12, 18, and 24 months)
- CTCAE Toxicity(3, 6, 12, 18, and 24 months)
研究者
Elysia Donovan
Radiation Oncologist
Juravinski Cancer Center