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

History of Changes

Tracking Information
First Received Date ^ICMJE	October 6, 2010
Last Updated Date	April 12, 2013
Start Date ^ICMJE	October 2010
Primary Completion Date	July 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 6, 2010)	Imaging of metastases [ Time Frame: One year ] [ Designated as safety issue: Yes ] Imaging of breast cancer metastases using 111-In-ABY015 for SPECT
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01216033 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 6, 2010)	Can the new molecule be used for imaging in extended studies [ Time Frame: October 2010 - June 2011 ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Exploratory Study of Breast Cancer With ABY025
Official Title ^ICMJE	An Exploratory Study to Evaluate the Distribution of [111In]ABY-025 Uptake for SPECT Imaging in Subjects With Metastatic Breast Cancer
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1 Phase 2
Study Design ^ICMJE	Endpoint Classification: Bio-availability Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Condition ^ICMJE	Breast Cancer
Intervention ^ICMJE	Drug: 111-In-ABY-025 Intravenous injection of the agent
Study Arm (s)	Not Provided
Publications *	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.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	7
Completion Date	July 2011
Primary Completion Date	July 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: female age >20 years one or more known metastases localizations Exclusion Criteria: other critical disease than breast cancer age ≤ 20 years
Gender	Female
Ages	20 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Sweden

Administrative Information
NCT Number ^ICMJE	NCT01216033
Other Study ID Numbers ^ICMJE	111InABY025
Has Data Monitoring Committee	Yes
Responsible Party	Dr. Henrik Lindman, Uppsala Akademiska Hospital
Study Sponsor ^ICMJE	Biomedical Radiation Sciences
Collaborators ^ICMJE	Swedish Cancer Society
Investigators ^ICMJE	Not Provided
Information Provided By	Biomedical Radiation Sciences
Verification Date	April 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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