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
  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:


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
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 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 July 24, 2014