The primary objective is to assess the contribution of HER2-PET to subsequent anti-HER2-therapy decisions. Secondary objectives are assessment of clinical value of HER2-PET for the referring clinician; correlation of HER2-PET with standard…
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
Secondary endpoints are
• Correlation of HER2-PET results and questionnaire results regarding clinical
value of HER2-PET for the referring clinician
• Correlation of HER2-PET results with standard conventional work-up
• Correlation of HER2-PET results and HER-2 expression by CTCs.
Background 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.
Study objective
The primary objective is to assess the contribution of HER2-PET to subsequent
anti-HER2-therapy decisions. Secondary objectives are assessment of clinical
value of HER2-PET for the referring clinician; correlation of HER2-PET with
standard conventional work-up and HER-2 expression by CTCs.
Study design
In this prospective 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. Blood sampling for CTC analysis will be drawn ahead of tracer
injection 4 days before the HER2-PET.
Intervention
Injection with the tracer 89Zr-trastuzumab and 89Zr-trastuzumab PET/CT four
days post injection.
Study burden and risks
For this study the patients will make in total 4 extra visits to the clinic.
After screening procedure is accomplished, patients will visit for blood
sampling (CTC analysis) and tracer injection, followed by the HER2-PET 4 days
later. Finally a result visit will take place. The HER2-PET implements a
radiation burden of 19.5 mSV. Furthermore, patients may experience side effects
of the tracer. Until now just once a side effect in terms of a hypersensitivity
reaction has been observed. Appropriate precautions have been taken to reduce
the risk of such an event. Potential benefit for the patients in this study
comes from the potential additional knowledge regarding HER2 receptor status of
the metastatic disease by means of the HER2-PET, and guiding of anti-HER2
therapy based on this PET. Also, this study will provide data that may improve
patient care in the future for other patients.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
1. Patients with a history of histological and/or cytological proven HER2-positive primary breast cancer. HER2-positivity is defined as:
a) HER2 immunohistochemical score of 3+, or
b) HER2 immunohistochemical score of 2+ and positive FISH for HER2/c-erbB2 amplification.
2. Patients with suspected metastatic disease or local recurrence of HER2-positive breast cancer and a clinical dilemma:
a) 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
b) in whom a biopsy is desirable but cannot (easily) be performed due to technical or patient factors or otherwise.
3. Standard work-up with imaging is defined as CT chest and abdomen, bone
scintigraphy, as well as FDG-PET.
4. Age >18 years of age.
5. WHO performance status 0-2.
Exclusion criteria
1. Pregnant or lactating women.
2. Prior allergic reaction to immunoglobulins or immunoglobulin allergy.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2012-003789-41-NL |
| ClinicalTrials.gov | NCT01832051 |
| CCMO | NL41707.042.12 |