NCT03655353招募中不适用
A Multicenter Phase II/III-study of 68Ga-ABY-025 PET for Non-invasive Quantification of HER2-expression in Advanced Breast Cancer
Henrik Lindman2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2018年8月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- HER2- expression by using 68Ga-ABY-025 PET.
研究概览
简要总结
A large multi- center phase II/III study with 68Ga-ABY-025 PET and biopsies in patients with advanced HER2-positive breast cancer, where the primary endpoint of the study is to find out the correlation between the HER2 expression measured by 68Ga-ABY-025 PET and standard histopathology from relevant tumor biopsies.
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
盲法说明
Investigators will determine HER2 expression by ABY-PET without knowledge of the results from the biopsies (in Phase III part).
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
- •Signed written informed consent.
- •Age ≥18 years.
- •Histologically or cytologically confirmed HER2-positive or borderline positive (for definition see below) adenocarcinoma of the breast.
- •HER2-positive defined as:
- •3+ by immunohistochemistry [IHC] in >10% of cell areas.
- •2+ by IHC in >10% of cell areas and HER2/CEP17 ratio ≥2.0 or HER2 copy number ≥ 6.0 by in situ hybridization [ISH]).
- •HER2-borderline positive defines as:
- •2+ by IHC and HER2/CEP17 ratio <2.0 and/or HER2 copy number 4.0 - 6.0 by in situ hybridization [ISH]) ("equivocal").
- •2+ by IHC and HER2/CEP17 ratio <2.0 and/or HER2 copy number <4.0 by in situ hybridization [ISH]) ("2+ ISH negative").
- •Known inhomogeneous HER2-expression in the primary tumor with HER2-positive areas <10% ("inhomogeneous").
- •Primary breast cancer planned for neoadjuvant therapy (Stage II-III, T2-4N0-3) or metastatic (M1; at least 80 pts).
- •At least one tumor lesion ≥ 10 mm.
- •At least one tumor lesion available for biopsy.
- •Newly diagnosed or confirmed progression and planned for therapy with trastuzumab emtansine or anti-HER2 targeted therapy(-ies) concomitant with chemotherapy (HER2-positive cohort) or chemotherapy (HER2-negative patients).
- •WHO performance status ≤
- •Predicted survival > 12 weeks.
- •Negative pregnancy test in women of childbearing potential (premenopausal or <12 months of amenorrhea post-menopause and who have not undergone surgical sterilization). Women of childbearing potential must use highly effective method of contraception, i.e combined hormonal contraception, or progestogen-only hormonal contraception, or intrauterine device, or intrauterine hormone-releasing system, or bilateral tubal occlusion, or vasectomized partner, or sexual abstinence
排除标准
- •Histologically or cytologically confirmed HER2-negative breast cancer defined as IHC 0 or 1+.
- •Other manifest malignancy.
- •Serious uncontrolled concomitant disease including congestive heart failure that would contraindicate the use of any anti-HER2 therapy.
- •Inadequate organ function, suggested by the following laboratory results:
- •Absolute neutrophil count <1,500 cells/mm3
- •Total bilirubin ≥1.5 x ULN (unless the patient has documented Gilbert's syndrome)
- •AST (SGOT) or ALT (SGPT) >5.0 × ULN
- •Serum creatinine clearance <30 ml/min
- •Patients of childbearing potential and sexually active and not willing to use highly effective contraceptive.
- •Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
结局指标
主要结局
HER2- expression by using 68Ga-ABY-025 PET.
时间窗: Approximately 10 days after study entry.
HER2-expression in tumors measured by 68Ga-ABY-025 PET, centrally analysed and result used for location of biopsy.
HER2-expression by analysing biopsy sample.
时间窗: Approximately 21 days after study entry.
HER2-expression in tumors by histopathology. Location of biopsy site based on HER2 expression seen in ABY-PET.
次要结局
未报告次要终点
研究者
Henrik Lindman
Coordinating Investigator
Uppsala University Hospital
研究点 (2)
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