Back to resultsClinical Value of 89Zr-trastuzumab PET
Primary Purpose
Metastatic Breast Cancer
Status
Completed
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
89Zr-trastuzumab injection
Sponsored by
About this trial
This is an interventional diagnostic trial for Metastatic Breast Cancer focused on measuring HER2-PET, 89Zr-trastuzumab, metastatic breast cancer, clinical dilemma
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
- Pregnant or lactating women.
- Prior allergic reaction to immunoglobulins or immunoglobulin allergy.
- Inability to comply with study procedures
Sites / Locations
- University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HER2-PET
Arm Description
Injection of 89Zr-trastuzumab followed by PET scan
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Correlation of HER2-PET results and questionnaire results regarding clinical value of HER2-PET for the referring clinician
Correlation of HER2-PET result (assessed about 1 week after scan) and questionnaire results (before, directly after, and 3 months after scan)
Correlation of HER2-PET results with standard conventional work-up
Correlation of HER2-PET result (assessed about 1 week after scan) and standard conventional work-up (assessed before/at screening)
Correlation of HER2-PET results and HER-2 expression by CTCs
Correlation of HER2-PET result (assessed about 1 week after scan) and HER-2 expression by CTCs (blood for CTC analysis will be drawn at day of tracer injection, analysis within 3 days)
Full Information
NCT ID
NCT01832051
First Posted
April 3, 2013
Last Updated
November 4, 2015
Sponsor
University Medical Center Groningen
1. Study Identification
Unique Protocol Identification Number
NCT01832051
Brief Title
Clinical Value of 89Zr-trastuzumab PET
Official Title
HER2-PET as a Diagnostic Tool in Breast Cancer Patients With a Clinical Dilemma
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Center Groningen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer
Keywords
HER2-PET, 89Zr-trastuzumab, metastatic breast cancer, clinical dilemma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HER2-PET
Arm Type
Experimental
Arm Description
Injection of 89Zr-trastuzumab followed by PET scan
Intervention Type
Drug
Intervention Name(s)
89Zr-trastuzumab injection
Primary Outcome Measure Information:
Title
Concordance between HER2-PET results and anti-HER2 therapy
Description
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.
Time Frame
about 2 years (end of study)
Secondary Outcome Measure Information:
Title
Correlation of HER2-PET results and questionnaire results regarding clinical value of HER2-PET for the referring clinician
Description
Correlation of HER2-PET result (assessed about 1 week after scan) and questionnaire results (before, directly after, and 3 months after scan)
Time Frame
about 2 years (end of study)
Title
Correlation of HER2-PET results with standard conventional work-up
Description
Correlation of HER2-PET result (assessed about 1 week after scan) and standard conventional work-up (assessed before/at screening)
Time Frame
about 2 years (end of study)
Title
Correlation of HER2-PET results and HER-2 expression by CTCs
Description
Correlation of HER2-PET result (assessed about 1 week after scan) and HER-2 expression by CTCs (blood for CTC analysis will be drawn at day of tracer injection, analysis within 3 days)
Time Frame
about 2 years (end of study)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Pregnant or lactating women.
Prior allergic reaction to immunoglobulins or immunoglobulin allergy.
Inability to comply with study procedures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
C.P. Schröder, PhD
Organizational Affiliation
University Medical Center Groningen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center
City
Groningen
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
Clinical Value of 89Zr-trastuzumab PET
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