Breast cancer. MedDRA version: 20.0 Level: PT Classification code 10006187 Term: Breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: ABY-025 labelled with gallium-68
Product Code: [68Ga]ABY-025
Pharmaceutical Form: Solution for injection
Sponsors
Region Uppsala
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: * Signed written informed consent. * Age =18 years. * Histologically or cytologically confirmed HER2-positive or borderline positive (for definition see below) adenocarcinoma of the breast. HER2-positive defined as: a. 3+ by immunohistochemistry [IHC] in >10% of cell areas. b. 2+ by IHC in >10% of cell areas and HER2/CEP17 ratio =2.0 or HER2 copy number = 6.0 by in situ hybridization [ISH]). HER2-borderline positive defines as: c. 2+ by IHC and HER2/CEP17 ratio 12 weeks 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 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: * Histologically or cytologically confirmed HER2-negative breast cancer defined as IHC 0 or 1+. * Other manifest malignancy. * Serious uncontrolled concomitant disease including congestive heart failure that would contraindicate the use of any anti-HER2 therapy. * Inadequate organ function, suggested by the following laboratory results: • Absolute neutrophil count 5.0 × ULN • Serum creatinine clearance <30 ml/min * Patients of childbearing potential and sexually active and not willing to use adequate contraceptive. * Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To correlate the HER2-expression in tumors measured by 68Ga-ABY-025 PET to gold standard histopathology based on IHC-status and ISH-analyses.;Secondary Objective: * To compare the HER2-expression in tumors measured by 68Ga-ABY-025 PET tumor to background ratio (TBR) to standardized uptake values (SUV). * Define optimal SUV and TBR cut-off values for separating metastatic HER2-status into HER2-negative and HER2-positive at 2, 3 and 4 hours in a subset of 40 patients. * To correlate the HER2-expression in tumors measured by 68Ga-ABY-025 PET standardized uptake values (SUV) to IHC-status and percentage of stained cells. * Study the intra-individual heterogeneity of HER2 expression (IHC and ISH) in patients with more than one metastasis = 1cm. * Study the variability of HER2 expression (IHC and ISH) between primary tumor and metastases. * To study if the investigation with 68Ga-ABY-025 PET leads to changes in the proposed treatment and in which proportion of the examined patients this occur.;Primary end point(s): To correlate the HER2-expression in tumors measured by 68Ga-ABY-025 PET to gold standard histopathology based on IHC-status and ISH-analyses.;Timepoint(s) of evaluation of this end point: Interim analysis year 2019, final analysis year 2021 (after end of study). | — |
Countries
Denmark, Finland, Sweden
Contacts
Public ContactPET Information
Jens Sörensen / PET center
Outcome results
None listed