mammacarcinoma metastatic breast cancer
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Patient with first presentation of MBC, regardless of ER and HER2 status of the primary tumor, who is eligible for first-line systemic therapy. - Patient with non-rapidly progressive MBC, not requiring urgent initiation of chemotherapy, based on clinician's evaluation - Patients in whom standard imaging work-up of MBC was recently (
Exclusion criteria
Exclusion criteria: - Contraindications for systemic treatment (as will be assigned based on biopsy and experimental scan results), either chemotherapy, hormonal therapy or anti-HER2 therapy, based on clinical judgment of treating medical oncologist and patient history. - Pregnant or lactating women. - Rapidly progressive (visceral) disease requiring rapid initiation of chemotherapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In patients with measurable disease: treatment response on CT at 8 weeks (day 56 ± 3), according to RECIST1.1 criteria (both per patient and per metastasis). In patients with (non-measurable) bone metastases only, clinical response to treatment: progressive disease is defined as substantial worsening of overall complaints, meriting discontinuation of therapy. (Non-)response is related to baseline 18F-FES-PET and 89Zr-trastuzumab-PET (both per patient and per metastasis analysis); and 18F-FDG-PET at 2 weeks of treatment (both per patient and per metastasis analysis). | — |
Secondary
| Measure | Time frame |
|---|---|
| - The relation between progression free survival (PFS, defined as time from start of treatment until moment of documented tumor progression or death) to either positive or negative baseline 18F-FES-PET, 89Zr-trastuzumab-PET and 2 week 18F-FDG-PET. - The relation between DNA sequencing and RNA expression analysis (including miRNA analysis) of the biopsy and venous blood samples to all molecular, imaging (standard and experimental) and clinical follow-up data (treatment response and survival). - The relation between miRNA analysis of the baseline biopsy and a venous blood sample at baseline, and all other molecular, imaging and clinical follow-up data. - The relation between peptide profiling of new baseline biopsy and venous blood samples (baseline and day of standard response assessment) and all other molecular, imaging and clinical follow-up data. - The assessment of molecular changes of primary biopsy, new baseline biopsy and (optional) biopsy taken during treatment and the relation to all other molecular, imaging and clinical follow up data. - The relation between CTC count (including comparison of enrichment methods) and ER/HER2 status of CTCs at baseline and all molecular findings of the available biopsies (primary, baseline and, if feasible later biopsies) and venous blood samples, all imaging and clinical follow-up data. - The assessment of circulating tumor DNA analysis at baseline, day of early 18F-FDG-PET and standard response assessment to the molecular findings of the available biopsies and venous blood samples, as well as to all imaging and clinical follow-up data. - The relation between peptide profiling of the baseline biopsy and venous blood samples (baseline and day of standard response assessment), and all other molecular, imaging and clinical follow-up data. - The relation between circulating miRNA analysis (baseline) and all other molecular, imaging and clinical follow-up data. - The quantification of the cost-effect | — |
Countries
Netherlands
Outcome results
None listed