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CompletedNCT01216033ABY0125Updated Apr 15, 2013

Exploratory Study of Breast Cancer With ABY025

A Phase 1/2 interventional study of 111-In-ABY-025 in Breast Cancer, sponsored by Biomedical Radiation Sciences. Completed at 1 site in Sweden. Open to female participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2013-04-15.

Sponsored by Biomedical Radiation Sciences · Phase 1/2, Interventional, and Diagnostic

Phase
Phase 1/2
Study type
Interventional
Enrollment
7
Allocation
Not applicable
Ages
20 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Breast Cancer

Keywords

  • Breast cancer
  • Diagnostics
  • HER2
  • Imaging
  • Metastases
  • SPECT
  • Imaging of metastases
03

In context

Breast Neoplasms

12,820 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.

This study's enrollment of 7 is below the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Biomedical Radiation Sciences is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • female age >20 years
  • one or more known metastases localizations

Exclusion criteria

Exclusion Criteria:

  • other critical disease than breast cancer
  • age ≤ 20 years
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
7 participants (actual)

Interventions

  • Drug111-In-ABY-025

    Intravenous injection of the agent

06

What researchers measure

Primary outcomes

  1. Imaging of metastases

    Imaging of breast cancer metastases using 111-In-ABY015 for SPECT

    Time frame: One year

Secondary outcomes

  1. Can the new molecule be used for imaging in extended studies

    Time frame: October 2010 - June 2011

07

Study locations

1 site
  • Akademiska Hospital
    Uppsala, Uppland SE75185, Sweden
08

References and documents

Publications

  • Carlsson J, Nordgren H, Sjostrom J, Wester K, Villman K, Bengtsson NO, Ostenstad B, Lundqvist H, Blomqvist C. HER2 expression in breast cancer primary tumours and corresponding metastases. Original data and literature review. Br J Cancer. 2004 Jun 14;90(12):2344-8. doi: 10.1038/sj.bjc.6601881. PubMed 15150568 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2010, a primary completion of Jul 2011 and a completion of Jul 2011. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 6, 2010
First posted
Oct 7, 2010
Start
Oct 2010
Primary completionActual
Jul 2011
CompletionActual
Jul 2011
Last update
Apr 15, 2013
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 15, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01216033
Lead sponsor
Biomedical Radiation Sciences
Collaborators
Swedish Cancer Society
First posted
Oct 7, 2010
Start date
Oct 2010
Primary completion
Jul 2011
Completion
Jul 2011
Last update
Apr 15, 2013

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.

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Discussion

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