Can HER2 Targeted PET/CT Imaging Identify Unsuspected HER2 Positive Breast Cancer Metastases, Which Are Amenable to HER2 Targeted Therapy?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Percentage of Patients With HER2- Primary Breast Cancer Who Develop Imagable HER2+ Metastases
研究概览
简要总结
Some breast cancer cells make a protein called Human Epidermal Growth factor receptor 2 (HER2). Patients with HER2 positive (HER2+) breast cancer receive medicine that attacks HER2, which helps these patients live longer. Some HER2 negative (HER2-) breast cancer patients also benefit from medicines that attack HER2, but we do not know why or which patients will benefit. This study uses a new imaging method, HER2-targeted PET/CT, to identify patients that may benefit from medicines that attack HER2. This is experimental.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women age > 18
- •Biopsy proven HER2 negative primary breast cancer and biopsy proven metastatic disease.
- •5 or more foci of demonstrable metastases on recent imaging modalities (CT, MR, FDG PET/CT)
- •ECOG performance score of 0-2
排除标准
- •Life expectancy < 3months
- •Pregnancy or lactation
- •Patients who cannot undergo PET/CT scanning because of weight limits
- •CNS only disease on recent imaging
研究组 & 干预措施
HER2-targeted PET/CT
Pts with confirmed HER2- breast cancer will then undergo HER2-targeted PET/CT. 89Zr-trastuzumab is a novel radiotracer which allows excellent visualization of HER2+ lesions. 89Zr-pertuzumab is a novel radiotracer which may allow for specific visualization of HER2+ lesions. PET/CT imaging with these novel radiotracers will allow evaluation of all identifiable malignant lesions, rather than evaluation of only single lesions by biopsy. Avid lesions will be considered suspicious for HER2+ malignancy. Pts with at least one 89Zr-trastuzumab or 89Zr-pertuzumab avid lesion will be biopsied to confirm HER2+ pathology. From these 50 pts, we will determine the proportion of HER2- primary breast cancer pts that express HER2+ malignancy imagable by HER2-targeted PET/CT. Pts recruited to the protocol, but then drop out prior to HER2-targeted PET/CT due HER2+ disease being identified on retesting of the patient's archived tissue samples, will be replaced with newly recruited pts.
干预措施: PET/CT scan (Device)
HER2-targeted PET/CT
Pts with confirmed HER2- breast cancer will then undergo HER2-targeted PET/CT. 89Zr-trastuzumab is a novel radiotracer which allows excellent visualization of HER2+ lesions. 89Zr-pertuzumab is a novel radiotracer which may allow for specific visualization of HER2+ lesions. PET/CT imaging with these novel radiotracers will allow evaluation of all identifiable malignant lesions, rather than evaluation of only single lesions by biopsy. Avid lesions will be considered suspicious for HER2+ malignancy. Pts with at least one 89Zr-trastuzumab or 89Zr-pertuzumab avid lesion will be biopsied to confirm HER2+ pathology. From these 50 pts, we will determine the proportion of HER2- primary breast cancer pts that express HER2+ malignancy imagable by HER2-targeted PET/CT. Pts recruited to the protocol, but then drop out prior to HER2-targeted PET/CT due HER2+ disease being identified on retesting of the patient's archived tissue samples, will be replaced with newly recruited pts.
干预措施: 89Zr-trastuzumab (Radiation)
HER2-targeted PET/CT
Pts with confirmed HER2- breast cancer will then undergo HER2-targeted PET/CT. 89Zr-trastuzumab is a novel radiotracer which allows excellent visualization of HER2+ lesions. 89Zr-pertuzumab is a novel radiotracer which may allow for specific visualization of HER2+ lesions. PET/CT imaging with these novel radiotracers will allow evaluation of all identifiable malignant lesions, rather than evaluation of only single lesions by biopsy. Avid lesions will be considered suspicious for HER2+ malignancy. Pts with at least one 89Zr-trastuzumab or 89Zr-pertuzumab avid lesion will be biopsied to confirm HER2+ pathology. From these 50 pts, we will determine the proportion of HER2- primary breast cancer pts that express HER2+ malignancy imagable by HER2-targeted PET/CT. Pts recruited to the protocol, but then drop out prior to HER2-targeted PET/CT due HER2+ disease being identified on retesting of the patient's archived tissue samples, will be replaced with newly recruited pts.
干预措施: 89Zr-pertuzumab (Radiation)
结局指标
主要结局
Percentage of Patients With HER2- Primary Breast Cancer Who Develop Imagable HER2+ Metastases
时间窗: 3 years
Both SUVmax and SUVpeak will be recorded for lesions, and SUVmax and SUVaverage will be recorded for background measurements. Only those foci qualitatively scored conspicuously positive by both readers (scores of 4 or 5) will be considered as "positive".
次要结局
未报告次要终点