We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Exploratory Study of Breast Cancer With ABY025 (ABY0125)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01216033
First Posted: October 7, 2010
Last Update Posted: April 15, 2013
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.
Collaborator:
Swedish Cancer Society
Information provided by:
Biomedical Radiation Sciences
  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: 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
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes 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
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 ClinicalTrials.gov identifier (NCT number): 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
First Submitted: October 6, 2010
First Posted: October 7, 2010
Last Update Posted: April 15, 2013
Last Verified: April 2013

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