A Randomized Phase II Study of Consolidative Surgery and Radiotherapy With Curative Intent for De Novo Oligometastatic HER2+ Breast Cancer [Ablation and Resection for the Consolidation of Oligometastatic HER2+ Breast Cancer (ARCHER)]
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 178
- 试验地点
- 7
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
The researchers are doing this study to see if the combination of surgery, locoregional radiation therapy, SBRT (stereotactic body radiation therapy), and the usual approach is more effective in treating oligometastatic HER2-positive breast cancer than the usual approach alone. The researchers will also study the side effects of the study treatment.
详细描述
Prior to randomization, patients will receive standard of care first-line systemic therapy as defined by NCCN guidelines (paclitaxel, trastuzumab and pertuzumab at the time of study activation). Following a 3-12 month period without evidence of progression as determined by the treating clinician, patients may be registered and then randomly assigned in 1:1 fashion to one of two study arms. All patients will be followed until progression of disease or 3 years after randomization, whichever comes first. All HER2-directed agents are FDA-approved and administered per standard of care practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Pathologically-confirmed metastatic breast cancer.
- •Oligometastatic breast cancer (≤5 discrete metastatic lesions) without CNS involvement; as seen on standard imaging during initial workup and monitoring prior to registration.
- •HER2-positive breast cancer per CAP/ASCO guidelines as determined by staff pathologist (any estrogen or progesterone receptor status).
- •Based on size and location, all metastatic sites can be safely treated with either SBRT or resection.
- •Enrolled at least 3 months (and up to 12 months) after initiation of first-line systemic therapy AND without evidence of progression as determined by treating clinician (whether clinically or radiographically) during this window. (ie. in the judgement of the treating clinician, based on standard evaluations, all known disease must be controlled prior to enrollment).
- •ECOG performance status 0-2; KPS 60-100
排除标准
- •Any foci of disease progression during initial 3-12 months of first-line systemic therapy (as determined by treating clinician)
- •Escalation of systemic therapy line due to progressive disease (i.e. initiated second-line therapy prior to enrollment).
- •Comorbidities precluding receipt of radiotherapy, surgery or standard systemic therapy.
- •Intracranial or intrathecal/intramedullary spinal disease (ie. CNS involvement is excluded from the study; epidural/vertebral disease is permitted)
- •Prior cancer history requiring chemotherapy within the past 10 years (ie. prior cancers are permitted provided no chemotherapy was administered).
- •Inclusion of Underrepresented Populations
- •Individuals of all races and ethnic groups are eligible for this trial. There is no bias towards age or race in the clinical trial outlined. This trial is open to the accrual of men and women.
研究组 & 干预措施
Standard of care arm
Continuation of first-line systemic therapy will receive the usual approach (drug therapy). Patients will be assigned to the continuation of first-line systemic therapy for an indefinite period per the standard of care. Escalation of systemic-therapy line is at the discretion of the treating physician per standard of care.
干预措施: Trastuzumab, Pertuzumab, Paclitaxel, or a combination of these drugs (Drug)
Consolidation arm
Patients will receive surgery, locoregional radiation therapy, SBRT, and the usual approach
干预措施: Lumpectomy or mastectomy (Procedure)
Consolidation arm
Patients will receive surgery, locoregional radiation therapy, SBRT, and the usual approach
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: 3 years
with PFS defined as the time of randomization to the date of clinical or radiographic disease progression or death (by any cause in the absence of progression).
次要结局
未报告次要终点