Molecular imaging: On the day of FES-injection\&scan or the day after FES-injection, 89Zr-trastuzumab (\~37 MBq) will be injected. The HER2-PET will be performed 4 days after tracerinjection.
Molecular imaging: All patients receive 18F-FES (\~200MBq) injection followed by a FES-PET.
Study summary
Current patient work-up, including conventional imaging and pathological assessment of just one single biopsy, might be insufficient to identify metastatic breast cancer patients, who possibly benefit from first-line anti-hormonal or anti-HER2 therapy. As receptor conversion of the tumor is found quite frequently and molecular heterogeneity can occur within one patient, up-to-date whole body information is necessary to determine estrogen receptor (ER) and/or human epidermal growth factor receptor 2 (HER2) receptor status and subsequently guide therapy decision. With molecular imaging via PET this information can be obtained in a non-invasive, patient friendly way. Furthermore, to improve and individualize treatment and be able to identify (new) drug targets and biomarkers, sampling of venous blood, circulating tumor cells (CTC), as well as circulating tumor DNA, microRNA (miRNA) and molecular characterization of one metastasis at the beginning and, if feasible, of an additional biopsy during therapy, is necessary.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 which may include:
* no recent (\< 2 weeks prior to screening visit) significant worsening of MBC related signs and symptoms according to patient history.
* in case of liver metastases: no significant increase in liver function tests alanine aminotransferase aspartate transaminase (ASAT) and alanine transaminase (ALAT) in 2 weeks prior to screening visit. (Significant increase of liver function test is defined as 50% increase of absolute amount of ASAT/ALAT.)
* Patients in whom standard imaging work-up of MBC was recently (≤ 28 days) performed. Standard imaging must include: CT chest/abdomen, 18F-FDG-PET and bone scintigraphy.
* Patient with measurable or clinically evaluable (bone only) disease on recent standard work up of MBC are eligible.
* Metastatic lesion(s) of which a histological biopsy can safely be obtained according to standard clinical care procedures.
* Primary tumor blocks available for confirmatory central laboratory ER/HER2 testing in the UMCG. If available a snap frozen sample of the primary tumor will also be centralized in the University Medical Center Groningen (UMCG).
* WHO performance status 0-2.
* Patient is able to undergo PET imaging procedures.
* Age \>18 years of age, willing and able to comply with the protocol as judged by the investigator.
* Signed written informed consent.
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.
* Prior allergic reaction to immunoglobulins or immunoglobulin allergy.
* Inability to comply with study procedures.
* Rapidly progressive (visceral) disease requiring rapid initiation of chemotherapy.
Primary outcome measure(s)
Clinical utility — 3-5 years (End of study) The primary objective is to evaluate the clinical utility of experimental PET scans, in the setting of MBC at first presentation. These scans include Fluor-18-16 alpha-fluoroestradiol(18F-FES)-PET and Zirconium-89(89Zr)-trastuzumab-PET scans at baseline, and 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose(18F-FDG)-PET for early response measurement. Clinical utility in this setting might be defined as improved personalized medicine, when the PET scans show improved predictive value for therapy response in comparison or in addition to currently available clinical information including a biopsy. But also when the PET scans would have the same predictive value for therapy response compared to a biopsy, they would have clinical utility because they are less invasive and more patient friendly. The inherent focus (the primary endpoint) of this study is therefore therapy response. Therapy response will be related to the novel PET scans, both per patient and per metastasis analysis.
Trial sites (3)
Facility
City
Region
Status
VU University Medical Center
Amsterdam
Netherlands
University Medical Center
Groningen
Netherlands
University Medical Center St. Radboud
Nijmegen
Netherlands
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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