NCT01832051

Brief Summary

Information about the presence of human epidermal growth factor receptor 2 (HER2) in tumor lesions in breast cancer patients is essential for diagnostic and therapeutic management of metastatic breast cancer. In daily practice however, obtaining a metastasis biopsy can be difficult or impracticable. Therefore, clinicians can be faced with a persistent clinical dilemma in some breast cancer patients, leading to suboptimal therapy decisions due to lack of HER2 receptor information. Circulating tumor cells (CTCs), which may provide additional information, have so far not been able to replace the biopsy. To solve this problem, non-invasive whole body visualization and quantification of HER2 expression by means of the HER2-PET may be a valuable tool. In this prospective multicenter imaging study, eligible patients will receive one HER2-PET and CTC analysis in addition to standard work up for metastatic disease. Subsequent administration of anti-HER2 therapy will be evaluated. Referring physicians fill in three questionnaires, one before HER2-PET and two after HER2-PET.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 3, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 15, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

November 5, 2015

Status Verified

November 1, 2015

Enrollment Period

2.3 years

First QC Date

April 3, 2013

Last Update Submit

November 4, 2015

Conditions

Metastatic Breast Cancer

Keywords

HER2-PET89Zr-trastuzumabmetastatic breast cancerclinical dilemma

Outcome Measures

Primary Outcomes (1)

  • Concordance between HER2-PET results and anti-HER2 therapy

    Concordance between HER2-PET results and anti-HER2 therapy is defined as HER2 positive lesion(s) on HER2-PET and subsequent anti-HER2 therapy; or no HER2 positive lesions on HER2-PET and no subsequent anti-HER2 therapy. It is considered a clinically relevant contribution of HER2-PET to anti-HER2-therapy decisions if there is a concordance in at least 2/3 of included patients.

    about 2 years (end of study)

Secondary Outcomes (3)

  • Correlation of HER2-PET results and questionnaire results regarding clinical value of HER2-PET for the referring clinician

    about 2 years (end of study)

  • Correlation of HER2-PET results with standard conventional work-up

    about 2 years (end of study)

  • Correlation of HER2-PET results and HER-2 expression by CTCs

    about 2 years (end of study)

Study Arms (1)

HER2-PET

EXPERIMENTAL

Injection of 89Zr-trastuzumab followed by PET scan

Drug: 89Zr-trastuzumab injection

Interventions

89Zr-trastuzumab injectionDRUG
HER2-PET

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a history of histological and/or cytological proven HER2-positive primary breast cancer. In the Netherlands HER2-positivity is defined as:
  • HER2 immunohistochemical score of 3+, or
  • HER2 immunohistochemical score of 2+ and positive FISH for HER2/c-erbB2 amplification.
  • In Belgium HER2-positivity is defined as positive FISH for HER2/c-erbB2 amplification.
  • Patients with suspected metastatic disease or local recurrence of HER2-positive breast cancer and a clinical dilemma:
  • in whom standard work up with imaging has failed to solve the clinical dilemma (diagnostic/therapeutic), leaving issues with regard to HER2 status of lesions and
  • in whom a biopsy is desirable but cannot (easily) be performed due to technical or patient factors or otherwise.
  • Standard work-up with imaging is defined as CT chest and abdomen, bone scintigraphy, as well as FDG-PET.
  • Age \>18 years of age.
  • WHO performance status 0-2.
  • Signed written informed consent.
  • Able to comply with the protocol.

You may not qualify if:

  • Pregnant or lactating women.
  • Prior allergic reaction to immunoglobulins or immunoglobulin allergy.
  • Inability to comply with study procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center

Groningen, Netherlands

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

zirconium-89-trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • C.P. Schröder, PhD

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

April 3, 2013

First Posted

April 15, 2013

Study Start

March 1, 2013

Primary Completion

June 1, 2015

Study Completion

October 1, 2015

Last Updated

November 5, 2015

Record last verified: 2015-11

Locations

NL(1)