EUCTR2017-002115-34-SE进行中（未招募）1 期
A multicenter phase II/III-study of 68Ga-ABY-025 PET for non-invasive quantification of HER2-expression in advanced breast cancer - Affibody-3
Region Uppsala0 个研究点目标入组 120 人开始时间: 2018年4月17日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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:
- •a.3+ by immunohistochemistry [IHC] in >10% of cell areas.
- •b.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:
- •c.2+ by IHC and HER2/CEP17 ratio <2.0 and/or HER2 copy number 4.0 - 6.0 by in situ hybridization [ISH]) (equivocal”).
- •d.2+ by IHC and HER2/CEP17 ratio <2.0 and/or HER2 copy number <4.0 by in situ hybridization [ISH]) (2+ ISH negative”).
- •e.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 = 2.
- •* Predicted survival > 12 weeks
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
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 adequate contraceptive.
- •* Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
研究者
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