The purpose of this study is to visualize and quantify ER-binding sites during treatment with Elacestrant (RAD1901)
The purpose of this study is to visualize and quantify ER-binding sites during treatment with Elacestrant (RAD1901) using 16α-18F-Fluoro-17β-estradiol (FES) positron emission tomography (PET) imaging
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
RAD1901, a novel selective ER degrader (SERD)
Institut Jules Bordet
Brussels, Belgium
UZ Leuven Campus Gasthuisberg
Leuven, Belgium
Vrije Universiteit Medisch Centrum (VUMC)
Amsterdam, Netherlands
Universitair Medisch Centrum Groningen (UMCG)
Groningen, Netherlands
Effect of ER Binding after RAD1901 treatment
To determine the effect of RAD1901 treatment on the estrogen receptor (ER) expression and estradiol binding to the ER in lesions from patients with metastatic breast cancer (mBC)
Time frame: 14 Days after the first dose
Correlation of FES uptake after RAD1901 treatment to clinical response
To determine if any changes in ER binding, as observed through FES uptake, correlate with clinical response
Time frame: Every 8 weeks for to up 12 months of treatment
Tumor response will be evaluated in patients with measurable or evaluable disease, using RECISTv1.1 guidelines
To determine if there is a tumor response to RAD1901 treatment
Time frame: Every 8 weeks for to up 12 months of treatment
Safety and Tolerability assessed in terms of adverse events, serious adverse events, ECG, physical examination, ECOG performance status, vital signs, and laboratory values
Characterization of the safety of RAD1901 in this patient population
Time frame: Up to 30 days after the end of treatment
Plasma concentrations of RAD1901 will be assessed at predefined intervals
Pharmacokinetic data will be collected.
Time frame: Every 28 days for up to 3 cycles
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Erasmus Medical Center
Rotterdam, Netherlands