Female subjects having metastatic breast cancer with verified HER2 positive status (DAKO's HerceptTest) in the original primary tumor or one of the current metastases.
Conditions
Interventions
Product Name: 111 In-ABY-002
Pharmaceutical Form: Powder for suspension for injection
Sponsors
Affibody AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the distribution of 111In-ABY-002 tracer uptake in normal organs and tumor lesions that are detectable with CT, with emphasis on identifying possible heterogeneity in uptake between and within individual metastatic lesions.;Secondary Objective: To assess the safety and tolerability of a single intravenous administration of 111In-ABY-002 in subjects with documented HER2-positive breast cancer, To investigate whole body dosimetry of 111In-ABY-002, To use the kinetics of radionucleide concentration in blood to estimate the absorbed dose in boone marrow.;Primary end point(s): Comparative image analysis of 111In-ABY-002 SPECT images and CT images; - tracer uptake coinciding with normal organ boundaries - tracer uptake coinciding with metastatic lesions visible on CT - focal tracer uptake in regions without pathological findings on CT | — |
Countries
Sweden
Outcome results
None listed