Fulvestrant for the Treatment of Recurrent or Metastatic Endometrial Carcinoma.

Study Overview
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Brief Summary
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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.

Official Title
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An Open, Non-randomised Multicentre Phase II Study to Assess the Efficacy and Tolerability of a 250 mg Monthly Dose of i.m. Applied Fulvestrant for the Treatment of Recurrent or Metastatic Endometrial Carcinoma.

Conditions
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Endometrial Carcinoma

Intervention / Treatment
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* Drug: Fulvestrant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed, recurrent or metastatic endometrial carcinoma Postmenopausal Hormonreceptor positive Exclusion Criteria: Pre-treatment with Fulvestrant Previous endocrine therapy of the endometrial carcinoma Previous malignancy less than 3 years ago other than in situ carcinoma of the cervix, basal cell carcinoma or squamous carcinoma of the skin

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Fulvestrant|A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Progression of Disease (TTP-Time To Progression, for ITT Set) | median TTP | 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) | 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 | 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). | ICF (Baseline) up to 12 months (12 visits) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Recurrent or metastatic endometrial carcinoma