Exploratory Study of Breast Cancer With ABY025 (ABY0125)
Primary Purpose
Breast Cancer
Status
Completed
Phase
Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
111-In-ABY-025
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancer focused on measuring Breast cancer, Diagnostics, HER2, Imaging, Metastases, SPECT, Imaging of metastases
Eligibility Criteria
Inclusion Criteria:
- female age >20 years
- one or more known metastases localizations
Exclusion Criteria:
- other critical disease than breast cancer
- age ≤ 20 years
Sites / Locations
- Akademiska Hospital
Outcomes
Primary Outcome Measures
Imaging of metastases
Imaging of breast cancer metastases using 111-In-ABY015 for SPECT
Secondary Outcome Measures
Can the new molecule be used for imaging in extended studies
Full Information
NCT ID
NCT01216033
First Posted
October 6, 2010
Last Updated
April 12, 2013
Sponsor
Biomedical Radiation Sciences
Collaborators
Swedish Cancer Society
1. Study Identification
Unique Protocol Identification Number
NCT01216033
Brief Title
Exploratory Study of Breast Cancer With ABY025
Acronym
ABY0125
Official Title
An Exploratory Study to Evaluate the Distribution of [111In]ABY-025 Uptake for SPECT Imaging in Subjects With Metastatic Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Biomedical Radiation Sciences
Collaborators
Swedish Cancer Society
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast cancer, Diagnostics, HER2, Imaging, Metastases, SPECT, Imaging of metastases
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
111-In-ABY-025
Intervention Description
Intravenous injection of the agent
Primary Outcome Measure Information:
Title
Imaging of metastases
Description
Imaging of breast cancer metastases using 111-In-ABY015 for SPECT
Time Frame
One year
Secondary Outcome Measure Information:
Title
Can the new molecule be used for imaging in extended studies
Time Frame
October 2010 - June 2011
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
female age >20 years
one or more known metastases localizations
Exclusion Criteria:
other critical disease than breast cancer
age ≤ 20 years
Facility Information:
Facility Name
Akademiska Hospital
City
Uppsala
State/Province
Uppland
ZIP/Postal Code
SE75185
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
15150568
Citation
Carlsson J, Nordgren H, Sjostrom 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. doi: 10.1038/sj.bjc.6601881.
Results Reference
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Exploratory Study of Breast Cancer With ABY025
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