Mammary carcinoma
Conditions
Interventions
Biopsy of the primary tumour or a metastasis to confirm HER-status. Applicible
only if the most recent biopsy is more than 16 weeks old, or if in that
timeframe a therapy switch occured.
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients with: - HER2+ or HER2-low breast cancer with metastatic disease, - and starting systemic therapy or having stable, RECIST measurable disease (with or without treatment). • A recent (18 years of age, willing and able to comply with the protocol as judged by the investigator. • Signed written informed consent. • Have a World Health Organisation (WHO) performance status of 0-2. • Life expectancy of > 3 months. • Have measurable disease based on RECIST 1.1. • Adequate organ and bone marrow function, as deemed acceptable by the treating physician
Exclusion criteria
Exclusion criteria: • Contraindications for systemic treatment (as will be assigned by treating physician). • Pregnant or lactating women. • Prior allergic reaction to immunoglobulins or immunoglobulin allergy. • Inability to comply with study procedures. • Has substance abuse or any other medical conditions such as clinically significant cardiac or psychological conditions, that may, in the opinion of the investigator, interfere with the subject*s participation in the clinical study or evaluation of the clinical study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Biodistribution: 89Zr-DFO*-trastuzumab uptake (standard uptake values (SUVmean, %ID/kg) in normal organs/tissues and bloodpool. - Biodistribution as above from historical controls with HER2+ breast cancer (n = 20) who underwent 89Zr-trastuzumab PET imaging. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Tumor uptake: 89Zr-DFO*-trastuzumab uptake (SUV, %ID/kg) in tumor lesions. - Tumor uptake as above in historical controls with HER2+ breast cancer (n = 20) who underwent 89Zr-trastuzumab PET imaging. - Whole blood and plasma PK of 89Zr-DFO*-trastuzumab - Image-derived PK for 89Zr-DFO*-trastuzumab - Literature-derived PK for unlabelled trastuzumab - Visual PET imaging analysis of tumor uptake of 89Zr-DFO*-trastuzumab and 89Zr-trastuzumab. - Tumor-to-blood ratio of 89Zr-DFO*-trastuzumab (whole blood and plasma as well as image derived) - Tumor-to-image derived blood uptake ratio of 89Zr-trastuzumab - HER2 expression measured by IHC on tumor biopsies | — |
Countries
Netherlands
Outcome results
None listed