FUlvestrant in Gynecological Cancers That Are Potentially Hormone Sensitive: the FUCHSia Study
Status:
Recruiting
Trial end date:
2025-12-31
Target enrollment:
Participant gender:
Summary
In this phase 2 clinical trial, the aim is to evaluate the efficacy of the ER-antagonist
Fulvestrant in women with estrogen receptor positive (ER+) low grade gynecological cancers.
The primary objective of the study is to determine the response rate (RR) upon Fulvestrant
treatment, comprising either partial or complete response, as determined by RECIST v1.1
criteria for each tumor type. The secondary objectives are to: (1) determine progression-free
survival (PFS) upon Fulvestrant treatment, after 3 years, in each tumor type group (2) assess
clinical benefit (CB) upon Fulvestrant treatment, comprising complete response, partial
response and stable disease, as determined by RECIST v1.1 criteria, in each tumor type group
(3) assess duration of response in each tumor type group (4) assess safety and tolerability
of Fulvestrant administration in each tumor type group (5) assess quality of life (QoL) and
symptoms in each tumor type group. As exploratory objectives, the aim is to: (1) evaluate the
feasibility of 16α-18F-fluoro-17β-estradiol (18F-FES) PET imaging for detection of ER
expression (2) determine the value of sequential 18F-FES PET scans in predicting response to
Fulvestrant (3) collect tumor biopsies and cf-DNA from patients enrolled in the trial. These
samples will be subsequently characterized at the genetic level, to identify adaptive
response mechanisms to Fulvestrant treatment.
Phase:
Phase 2
Details
Lead Sponsor:
Frederic Amant
Collaborators:
FWO Research Fund Flanders Kom Op Tegen Kanker Kom op tegen Kanker (Stand-up-to-Cancer), the Flemish cancer society