The purpose of this study is to assess the safety and effectiveness of AZD4547 in combination with fulvestrant vs. fulvestrant alone in ER+ breast cancer patients with FGFR1 polysomy (FISH4/5) or gene amplification (FISH 6)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
127
Tablet oral twice daily
Tablet oral once daily
Tablet oral twice daily
Research Site
Leuven, Belgium
Research Site
Namur, Belgium
Research Site
Brno, Czechia
Safety and Tolerability in Terms of Number of Patients With Adverse Events (Serious and Non-serious)
Time frame: 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
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A monthly intramuscular injection of a depot formulation with a loading dose 14 days after initial administration
Research Site
Prague, Czechia
Research Site
Villejuif, France
Research Site
Erlangen, Germany
Research Site
München, Germany
Research Site
Rostock, Germany
Research Site
Budapest, Hungary
Research Site
Kaposvár, Hungary
...and 11 more locations