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Adenosarcoma of Uterus clinical trials

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NCT ID: NCT03926936 Completed - Endometrial Cancer Clinical Trials

FUlvestrant in Gynecological Cancers That Are Potentially Hormone Sensitive: the FUCHSia Study

FUCHSia
Start date: March 13, 2019
Phase: Phase 2
Study type: Interventional

This phase 2 clinical trial aims to evaluate the efficacy of Fulvestrant, an ER-antagonist, in women with estrogen receptor positive (ER+) low-grade gynecological cancers. The primary objective is to determine the response rate (RR) to Fulvestrant, defined by partial or complete response according to RECIST v1.1 criteria. Secondary objectives include assessing progression-free survival (PFS) over 3 years, clinical benefit (CB), duration of response, safety and tolerability, and quality of life (QoL) in each tumor type group. Exploratory objectives involve evaluating the feasibility of 18F-FES PET imaging for detecting ER expression, the predictive value of sequential 18F-FES PET scans for treatment response, and collecting tumor biopsies and cf-DNA for genetic analysis to identify adaptive response mechanisms to Fulvestrant.