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Exploratory Study of Breast Cancer With ABY025 (ABY0125)

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

Condition Intervention Phase
Breast Cancer
Drug: 111-In-ABY-025
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: An Exploratory Study to Evaluate the Distribution of [111In]ABY-025 Uptake for SPECT Imaging in Subjects With Metastatic Breast Cancer

Resource links provided by NLM:

Further study details as provided by Biomedical Radiation Sciences:

Primary Outcome Measures:
  • Imaging of metastases [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: October 2010 - June 2011 ] [ Designated as safety issue: Yes ]

Enrollment: 7
Study Start Date: October 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: 111-In-ABY-025
    Intravenous injection of the agent

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • other critical disease than breast cancer
  • age ≤ 20 years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01216033

Akademiska Hospital
Uppsala, Uppland, Sweden, SE75185
Sponsors and Collaborators
Biomedical Radiation Sciences
Swedish Cancer Society
  More Information

Responsible Party: Dr. Henrik Lindman, Uppsala Akademiska Hospital Identifier: NCT01216033     History of Changes
Other Study ID Numbers: 111InABY025 
Study First Received: October 6, 2010
Last Updated: April 12, 2013
Health Authority: Sweden: Medical Products Agency

Keywords provided by Biomedical Radiation Sciences:
Breast cancer
Imaging of metastases

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases processed this record on October 21, 2016