HER2-PET as a Diagnostic Tool in Breast Cancer Patients With a Clinical Dilemma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Concordance between HER2-PET results and anti-HER2 therapy
研究概览
简要总结
Information about the presence of human epidermal growth factor receptor 2 (HER2) in tumor lesions in breast cancer patients is essential for diagnostic and therapeutic management of metastatic breast cancer. In daily practice however, obtaining a metastasis biopsy can be difficult or impracticable. Therefore, clinicians can be faced with a persistent clinical dilemma in some breast cancer patients, leading to suboptimal therapy decisions due to lack of HER2 receptor information. Circulating tumor cells (CTCs), which may provide additional information, have so far not been able to replace the biopsy. To solve this problem, non-invasive whole body visualization and quantification of HER2 expression by means of the HER2-PET may be a valuable tool.
In this prospective multicenter imaging study, eligible patients will receive one HER2-PET and CTC analysis in addition to standard work up for metastatic disease. Subsequent administration of anti-HER2 therapy will be evaluated. Referring physicians fill in three questionnaires, one before HER2-PET and two after HER2-PET.
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
- •Patients with a history of histological and/or cytological proven HER2-positive primary breast cancer. In the Netherlands HER2-positivity is defined as:
- •HER2 immunohistochemical score of 3+, or
- •HER2 immunohistochemical score of 2+ and positive FISH for HER2/c-erbB2 amplification.
- •In Belgium HER2-positivity is defined as positive FISH for HER2/c-erbB2 amplification.
- •Patients with suspected metastatic disease or local recurrence of HER2-positive breast cancer and a clinical dilemma:
- •in whom standard work up with imaging has failed to solve the clinical dilemma (diagnostic/therapeutic), leaving issues with regard to HER2 status of lesions and
- •in whom a biopsy is desirable but cannot (easily) be performed due to technical or patient factors or otherwise.
- •Standard work-up with imaging is defined as CT chest and abdomen, bone scintigraphy, as well as FDG-PET.
- •Age >18 years of age.
- •WHO performance status 0-
- •Signed written informed consent.
- •Able to comply with the protocol.
排除标准
- •Pregnant or lactating women.
- •Prior allergic reaction to immunoglobulins or immunoglobulin allergy.
- •Inability to comply with study procedures
研究组 & 干预措施
HER2-PET
Injection of 89Zr-trastuzumab followed by PET scan
干预措施: 89Zr-trastuzumab injection (Drug)
结局指标
主要结局
Concordance between HER2-PET results and anti-HER2 therapy
时间窗: about 2 years (end of study)
Concordance between HER2-PET results and anti-HER2 therapy is defined as HER2 positive lesion(s) on HER2-PET and subsequent anti-HER2 therapy; or no HER2 positive lesions on HER2-PET and no subsequent anti-HER2 therapy. It is considered a clinically relevant contribution of HER2-PET to anti-HER2-therapy decisions if there is a concordance in at least 2/3 of included patients.
次要结局
- Correlation of HER2-PET results and questionnaire results regarding clinical value of HER2-PET for the referring clinician(about 2 years (end of study))
- Correlation of HER2-PET results with standard conventional work-up(about 2 years (end of study))
- Correlation of HER2-PET results and HER-2 expression by CTCs(about 2 years (end of study))
研究者
C.P. Schroder
MD, PhD
University Medical Center Groningen