Metastatic breast cancer
Conditions
Interventions
Product Name: 89Zr-SUCDF-trastuzumab
Product Code: none
Pharmaceutical Form: Solution for injection
INN or Proposed INN: 89Zr-sucDF-Trastuzumab
CAS Number: none
Current Sponsor code: none
Concentratio
Sponsors
University Medical Center Groningen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Patients with a history of histological and/or cytological proven HER2-positive primary breast cancer. HER2-positivity is defined as: i. HER2 immunohistochemical score of 3+, or ii. HER2 immunohistochemical score of 2+ and positive FISH for HER2/c-erbB2 amplification. •Patients with suspected metastatic disease or local recurrence of HER2-positive breast cancer and a clinical dilemma: i.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 ii.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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: 1.Pregnant or lactating women. 2.Prior allergic reaction to immunoglobulins or immunoglobulin allergy. 3.Inability to comply with study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to assess the contribution of HER2-PET to subsequent anti-HER2-therapy decisions, in patients suspected of metastatic or locally recurrent HER2-positive breast cancer, with a clinical dilemma defined as failure of standard work up to evaluate the HER2 receptor status of their disease. ;Secondary Objective: To determine the clinical value of HER2-PET to improve diagnostic and therapeutic understanding for the referring physician. To evaluate the concordance of HER2-PET with standard conventional work-up. To analyze the correlation between 89Zr-trastuzumab uptake of the tumor lesions and HER-2 expression on CTCs. ;Primary end point(s): 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. ;Timepoint(s) of evaluation of this end point: Up to 6 weeks before HER2-PET, up to 4 weeks after HER2-PET and more than 3 months after HER2-PET | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 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. ;Timepoint(s) of evaluation of this end point: Up to 6 weeks before HER2-PET, up to 4 weeks after HER2-PET, more than 3 months after HER2-PET | — |
Countries
Netherlands
Contacts
Public ContactCP. Schröder
University Medical Center Groningen
Outcome results
None listed