Fulvestrant in gynecological cancers that are potentially hormone sensitive: the FUCHSia study (FUCHSia Study)

Here, we aim to set up a Phase II, multicenter study to test the efficacy of Fulvestrant in patients with ER-positive low-grade gynecological cancers. Fulvestrant is an anti-ER drug already approved for ER-positive metastatic breast cancer in postmenopausal women progressing under previous endocrine treatments. Because of its peculiar mechanisms of action, there are indeed high
chances that tumors developing resistance to other hormone therapies would still respond to Fulvestrant, making it a valuable alternative therapeutic strategy. We will assess the feasibility of
18F-FES-PET/MRI technique to monitor disease’s response and evolution during treatment in order to assess its potential use as a predictive/prognostic biomarker. Results from this study will help to introduce molecular-based stratification approaches in the design of clinical trials for hormone therapies and potentially accelerate the approval of Fulvestrant for treatment of selected low-grade gynecological cancer patients.