A Phase II Study of Local Therapy Only (Stereotactic Radiosurgery and/or Surgery) for Treatment of up to 5 Brain Metastases From HER2 Positive Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- to assess the percentage of patients treated with whole brain radiotherapy within 12 months after completion of local therapy
研究概览
简要总结
This study aims to show that brain metastases from Human Epidermal Growth Factor Receptor Type 2 (HER2) positive breast cancers are able to be controlled by local therapies, Stereotactic Radiosurgery (SRS) and/or Neurosurgery (NS), without the need for Whole Brain Radiotherapy (WBRT).
详细描述
For patients who have Human Epidermal Growth Factor Receptor Type 2 (HER2) positive breast cancer, which has metastasised to the brain, the main treatment options for these brain metastases are Whole Brain Radiotherapy (WBRT), Stereotactic Radiosurgery (SRS) and Neurosurgery (NS).
The purpose of the study is to determine:
- . How likely the tumours are controlled after treatment with local therapies Neurosurgery (NS) and/or Stereotactic Radiosurgery (SRS).
- . How likely is it that other tumours develop at new sites in the brain when no Whole Brain Radiotherapy (WBRT) is given.
This study is aiming to recruit 50 participants that have HER2 positive metastatic breast cancer with 1-5 synchronous brain metastases, with at least one metastasis requiring treatment.
The local treatment offered will be determined by the participant's doctor in consultation with the site multidisciplinary team and will be dependent on the size and location of the brain metastases. Each treatment will be performed by the specialist in that field, i.e. neurosurgeon and/or radiation oncologist.
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 years or older
- •Metastatic HER2 positive breast cancer
- •1-5 synchronous brain metastases
- •At least one metastases requiring treatment
- •Maximum volume of any single PTV <10cm3
- •Summated volume of all lesions to be treated with SRS is < 15cm
- •If a lesion is too small for treatment and will be observed, then its volume is not included in this summation
- •Absent or stable extracranial disease or active extracranial disease that is likely to be controlled with further HER-2 targeted therapy
- •Receiving systemic HER2 targeted therapy, or planned to receive within 4 weeks of completion of brain metastasis treatment
- •Able to undergo MRI scanning
排除标准
- •Previous treatment to the target brain metastases (excluding surgery within 6 weeks of registration)
- •Previous whole brain radiotherapy (WBRT)
- •Any brain metastasis that is greater than 30mm in size and unable to be resected
- •Leptomeningeal disease
- •Pregnant or breastfeeding
结局指标
主要结局
to assess the percentage of patients treated with whole brain radiotherapy within 12 months after completion of local therapy
时间窗: 12 months after completion of local therapy
次要结局
- To describe local brain failure incidence, at any site of SRS or surgery(12 months after completion of local therapy)
- To describe adverse events and need for corticosteroids(Baseline and at 7-14 days, 3 months, 6 months, 9 months, and 12 months after completion of local therapy)
- To describe neurocognitive function using the mini-mental state examination (MMSE)(Baseline, and at 3, 6, 9, and 12 months after completion of local therapy)
- To describe overall survival and cause of death (neurologic vs. non-neurologic)(12 months after completion of local therapy)
- To describe distant brain failure incidence (overall and by number of treated metastases)(12 months after completion of local therapy)
- To describe the pattern of first failure(12 months after completion of local therapy)
- To describe extra-cranial failure incidence(12 months after completion of local therapy)