E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 β-human chorionic gonadotropin, β-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.
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | |