HER2-PET as a diagnostic tool in breast cancer patients with a clinical dilemma

Phase 2

Completed

Conditions: breast cancer
mamma carcinoma
10006291

Registration Number: NL-OMON39796

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are<br /><br>• Correlation of HER2-PET results and questionnaire results regarding clinical<br /><br>value of HER2-PET for the referring clinician<br /><br>• Correlation of HER2-PET results with standard conventional work-up<br /><br>• Correlation of HER2-PET results and HER-2 expression by CTCs. </p><br>