The purpose of this study is to determine the efficacy of a monthly administration of Fulvestrant in patients with recurrent or metastatic endometrial carcinoma by assessment of the clinical tumour response after 3 injections.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
35
A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.
Research Site
Erlangen, Germany
Research Site
Göttingen, Germany
Research Site
Halle, Germany
Research Site
Jena, Germany
Determination (for ITT (Intet-to-Treat Set): Efficacy of a Monthly Administration of Fulvestrant in Patients With Recurrent or Metastatic Endometrial Carcinoma by Assessment of the Clinical Tumour Response After 3 Injections of Fulvestrant
Number of patients with Complete Remission (CR) and Partial Response (PR), as determined by an independent expert panel according to the WHO response criteria.
Time frame: up to 1 year
Time to Progression of Disease (TTP-Time To Progression, for ITT Set)
median TTP
Time frame: ICF (Informed Consent Form completed) to the date of objective progression or death (by any cause in the absence of progression)
Determination (for ITT Set): Median Survival
median overall survival (OS)
Time frame: ICF to the date of death
Determination (All Subjects Treated (AST) Set): Safety and Toxicity by Assessment of the Frequency of Grade I-IV Haematological and Non-haematological Toxicities
number of adverse events
Time frame: ICF to Last Patient Out (LPO)
Evaluation (Patient-reported): Change From Baseline in Health-related Quality of Life (HR-QoL) at 12 Months (12 Visits)
Patient-reported FACT-EN questionaire. Presented is the change from baseline after 12 visits/12 months. The overall total score of 43 single items was transformed to a scale from 0 to 100 (0 = worst level of well-being; 100 = highest level of well-being).
Time frame: ICF (Baseline) up to 12 months (12 visits)
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Research Site
Lübeck, Germany
Research Site
Mainz, Germany
Research Site
Münster, Germany
Research Site
Neunkirchen, Germany
Research Site
Rostock, Germany