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Exploratory Study of Breast Cancer With ABY025 (ABY0125)

This study has been completed.
Sponsor:
Collaborator:
Swedish Cancer Society
Information provided by:
Biomedical Radiation Sciences
ClinicalTrials.gov Identifier:
NCT01216033
First received: October 6, 2010
Last updated: April 12, 2013
Last verified: April 2013
History of Changes
  Purpose

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:

U.S. FDA Resources

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
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01216033

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

Publications:

Responsible Party: Dr. Henrik Lindman, Uppsala Akademiska Hospital
ClinicalTrials.gov 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
Diagnostics
HER2
Imaging
 Metastases
SPECT
Imaging of metastases

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 22, 2013