endometrial stromal sarcoma uterine adenosarcoma endometrial carcinoma sex cord stromal tumors serous ovarian cancer
Conditions
Interventions
Trade Name: Faslodex
Product Name: Fulvestrant
Pharmaceutical Form: Solution for injection
Sponsors
University Hospitals Leuven
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Written informed consent prior admission to the study Age = 18 years at the moment of signing the informed consent Recurrent or metastatic low grade uterine sarcomas (LGESS, LGAS without sarcomatous overgrowth and LGLMS), low-grade endometrial carcinomas, sex cord stromal tumors (granulosa cell tumors...) and low grade serous ovarian cancer Measurable disease, according to RECIST v1.1 criteria, assessed by CT scans ER-positive tumors based on immunohistochemistry, more than 10% of tumor cells should be positive for ER. After the study, central analysis of ER staining will be assessed using the Allred scoring system (based on intensity and percentage of positive cells, see Appendix 4) and archival tissue (=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: • Any other active malignancy or primary malignancy diagnosed within the previous 5 years, except for adequately treated squamous or basal cell carcinoma of the skin or in situ cervical carcinoma • Patients currently receiving (and unwilling to discontinue) any estrogen replacement therapy. • Patients participating in a study or having participated in a study of an investigational agent and received study therapy (or used an investigational device) within 4 weeks prior to study Day 1 • Patients who received prior chemo- or targeted therapy within 4 weeks prior to study Day 1 or who has not recovered from adverse events (i.e., adverse event not resolved to = Grade 1 or baseline), due to a previously administered agent • Patients with no archival tissue available, except for patients from whom an additional fresh core biopsy can be obtained for ER assessment • Any other disease, metabolic dysfunction, physical examination or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, may affect the interpretation of the results, render the patient at high risk from treatment complications or interfere with obtaining informed consent. • Any condition not permitting compliance with the study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the response rate (RR) upon Fulvestrant treatment, comprising either partial or complete response, as determined by RECIST v1.1 criteria, in each tumor type group;Secondary Objective: •To determine progression-free survival (PFS) upon Fulvestrant treatment, after 3 years, in each tumor type group •To assess duration of response in each tumor type group •To assess safety and tolerability of Fulvestrant administration in each tumor type group •To assess quality of life (QoL) and symptoms in each tumor type group ;Primary end point(s): Response rate (RR) upon Fulvestrant treatment in each tumor type group for the total number of patients from both the exploratory and confirmation cohort (interim analysis planned at Week 24), as determined by RECIST v1.1 criteria and assessed by computer tomography (CT) scans ;Timepoint(s) of evaluation of this end point: Every 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Progression-free survival (PFS) at 3 years in each tumor type group • Overall survival (OS) • Time to progression (TTP) • Clinical benefit rate (CBR) (CR + PR + stable disease [SD], SD of any duration) at interim analysis (IA, Week 24) and after 3 years, for each tumor type group • Safety and tolerability of Fulvestrant administration in each tumor type group • Change from baseline in QoL scores, as assessed by questionnaires EQ-5D and EORTC QLQ-C30 at the time of inclusion, at the end of the treatment and during follow-up ;Timepoint(s) of evaluation of this end point: PFS: at 3 years OS: at time of death Time to progression: at time of diagnosis of progressive disease Clinical benefit rate: every 3 months Safety and tolerability: every 3 months QoL: every 3 months | — |
Countries
Belgium, Netherlands
Contacts
Public ContactFUCHSia trial information
University Hospitals Leuven
Outcome results
None listed