Fulvestrant for the Treatment of Recurrent or Metastatic Endometrial Carcinoma.

Phase 2

Completed

• Conditions: Endometrial Carcinoma

• Registration Number: NCT00334295
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-12
• Study First Submitted: 2006-06-05
• Study First Submitted QC: 2006-06-05
• Study First Posted: 2006-06-07
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Results First Submitted: 2012-01-11
• Status Verified: 2012-06
• Results First Submitted QC: 2012-06-11
• Last Update Submitted: 2012-06-11
• Results First Posted: 2012-07-31
• Last Update Posted: 2012-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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	up to 1 year	Number of patients with Complete Remission (CR) and Partial Response (PR), as determined by an independent expert panel according to the WHO response criteria.

Secondary Outcome Measures

Name	Time	Method
Time to Progression of Disease (TTP-Time To Progression, for ITT Set)	ICF (Informed Consent Form completed) to the date of objective progression or death (by any cause in the absence of progression)	median TTP
Determination (for ITT Set): Median Survival	ICF to the date of death	median overall survival (OS)
Determination (All Subjects Treated (AST) Set): Safety and Toxicity by Assessment of the Frequency of Grade I-IV Haematological and Non-haematological Toxicities	ICF to Last Patient Out (LPO)	number of adverse events
Evaluation (Patient-reported): Change From Baseline in Health-related Quality of Life (HR-QoL) at 12 Months (12 Visits)	ICF (Baseline) up to 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).

Trial Locations

Locations (1)

Research Site; 🇩🇪 Rostock, Germany