Exploratory Study of Breast Cancer With ABY025

Breast Cancer Clinical Trial

— ABY0125  

Official title:

An Exploratory Study to Evaluate the Distribution of [111In]ABY-025 Uptake for SPECT Imaging in Subjects With Metastatic Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01216033
• Other study ID #: 111InABY025
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 6, 2010
• Last updated: April 12, 2013
• Start date: October 2010
• Est. completion date: July 2011

Study information

• Verified date: April 2013
• Source: Biomedical Radiation Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• female age >20 years

• one or more known metastases localizations

Exclusion Criteria:

• other critical disease than breast cancer

• age = 20 years

Study Design

Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• 111-In-ABY-025
Intravenous injection of the agent

Locations

Country	Name	City	State
Sweden	Akademiska Hospital	Uppsala	Uppland

Sponsors (2)

Lead Sponsor	Collaborator
Biomedical Radiation Sciences	Swedish Cancer Society

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Imaging of metastases	Imaging of breast cancer metastases using 111-In-ABY015 for SPECT	One year	Yes
Secondary	Can the new molecule be used for imaging in extended studies		October 2010 - June 2011	Yes