An exploratory study to assess the distribution of 111In-ABY-002 tracer uptake for SPECT imaging in subjects with metastatic HER2-positive breast cancer

Affibody AB0 个研究点开始时间: 2007年7月5日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•a) Female subjects > 18 years of age
•b) Diagnosis of breast cancer
•c) HER2-positive diagnosis of the primary tumor or one of the current metastases based on DAKO’s HercepTest, IHC 3+ expression status, or IHC 2+ and HER2 gene amplified according to FISH
•d) Volumetrically quantifiable tumor lesions on CT with at least one lesion > 1.0 cm in greatest diameter (quantification) outside the liver.
•e) ECOG performance status of = 2.
•f) Life expectancy of at least 12 weeks
•g) Hematological, liver and renal function test results = grade 2 toxicity (NCI toxicity grading)
•h) A negative pregnancy test (serum or urine ß-human chorionic gonadotropin, ß-HCG) at screening for women of childbearing potential. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception
•i) Subject is capable to undergo the diagnostic investigations to be performed in the study
•j) Subject is capable of understanding and signing an informed consent form.
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•a) Known hypersensitivity to ABY-002 or any of its excipients
•b) Known hypersensitivity to DOTArem
•c) Serious non-malignant disease or current other malignancy (other than breast cancer)
•d) Active current allergic or autoimmune disease or (family) history of autoimmune disease or any condition requiring long-term use of oral corticosteroids, such as asthma
•e) Active infection or history of severe infection within the previous 3 months
•f) Known HIV positive or chronically active hepatitis B or C
•g) Pregnant or breast-feeding

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