Exploratory Study of Breast Cancer With ABY025 (ABY0125)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01216033
Recruitment Status : Completed
First Posted : October 7, 2010
Last Update Posted : April 15, 2013
Swedish Cancer Society
Information provided by:
Biomedical Radiation Sciences

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: 111-In-ABY-025 Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
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
Study Start Date : October 2010
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Imaging of metastases [ Time Frame: One year ]
    Imaging of breast cancer metastases using 111-In-ABY015 for SPECT

Secondary Outcome Measures :
  1. Can the new molecule be used for imaging in extended studies [ Time Frame: October 2010 - June 2011 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01216033

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

Responsible Party: Dr. Henrik Lindman, Uppsala Akademiska Hospital Identifier: NCT01216033     History of Changes
Other Study ID Numbers: 111InABY025
First Posted: October 7, 2010    Key Record Dates
Last Update Posted: April 15, 2013
Last Verified: April 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