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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: Intervention Model: Single Group Assignment
Masking: None (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 ]
    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 ]

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)
Sexes 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
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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

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 August 22, 2017