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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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
AstraZeneca Germany Medical Director, MD
Germany: Federal Institute for Drugs and Medical Devices