Exploratory Study of Breast Cancer With ABY025 (ABY0125)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01216033
Recruitment Status : Completed
First Posted : October 7, 2010
Last Update Posted : April 15, 2013
Swedish Cancer Society
Information provided by:
Biomedical Radiation Sciences

October 6, 2010
October 7, 2010
April 15, 2013
October 2010
July 2011   (Final data collection date for primary outcome measure)
Imaging of metastases [ Time Frame: One year ]
Imaging of breast cancer metastases using 111-In-ABY015 for SPECT
Same as current
Complete list of historical versions of study NCT01216033 on Archive Site
Can the new molecule be used for imaging in extended studies [ Time Frame: October 2010 - June 2011 ]
Same as current
Not Provided
Not Provided
Exploratory Study of Breast Cancer With ABY025
An Exploratory Study to Evaluate the Distribution of [111In]ABY-025 Uptake for SPECT Imaging in Subjects With Metastatic Breast Cancer
The aim is to study if breast cancer metastases accumulate the newly developed HER2 binding molecule 111-In-ABY025 and if that shows whether the metastases express HER2.
Not Provided
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Breast Cancer
Drug: 111-In-ABY-025
Intravenous injection of the agent
Not Provided
Carlsson J, Nordgren H, Sjöström J, Wester K, Villman K, Bengtsson NO, Ostenstad B, Lundqvist H, Blomqvist C. HER2 expression in breast cancer primary tumours and corresponding metastases. Original data and literature review. Br J Cancer. 2004 Jun 14;90(12):2344-8. Review.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
July 2011
July 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • female age >20 years
  • one or more known metastases localizations

Exclusion Criteria:

  • other critical disease than breast cancer
  • age ≤ 20 years
Sexes Eligible for Study: Female
20 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Dr. Henrik Lindman, Uppsala Akademiska Hospital
Biomedical Radiation Sciences
Swedish Cancer Society
Not Provided
Biomedical Radiation Sciences
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP