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Exploratory Study of Breast Cancer With ABY025 (ABY0125)

This study has been completed.
Sponsor:
Collaborator:
Swedish Cancer Society
Information provided by:
Biomedical Radiation Sciences
ClinicalTrials.gov Identifier:
NCT01216033
First received: October 6, 2010
Last updated: April 12, 2013
Last verified: April 2013

October 6, 2010
April 12, 2013
October 2010
July 2011   (final data collection date for primary outcome measure)
Imaging of metastases [ Time Frame: One year ] [ Designated as safety issue: Yes ]
Imaging of breast cancer metastases using 111-In-ABY015 for SPECT
Same as current
Complete list of historical versions of study NCT01216033 on ClinicalTrials.gov Archive Site
Can the new molecule be used for imaging in extended studies [ Time Frame: October 2010 - June 2011 ] [ Designated as safety issue: Yes ]
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
Interventional
Phase 1
Phase 2
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
7
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
Female
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01216033
111InABY025
Yes
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