NCT00944918

Study of Faslodex With or Without Concomitant Arimidex Versus Exemestane Following Progression on Non-steroidal Aromatase Inhibitors (NSAI)

A Partially-blind Phase III Randomised Trial of Fulvestrant (Faslodex) With or Without Concomitant Anastrozole (Arimidex) Compared With Exemestane in Postmenopausal Women With ER+ve Locally Advanced/Metastatic Breast Cancer Following Progression on Non-steroidal Aromatase Inhibitors

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A partially-blind, randomised, multicentre phase III trial of Faslodex plus concomitant Arimidex versus Faslodex plus Arimidex-Placebo versus exemestane in postmenopausal locally advanced / metastatic breast cancer patients who have progressed on NSAIs. Randomisation to Faslodex ± Arimidex / Arimidex-Placebo or exemestane will be open (1:1:1). For Faslodex treated patients the randomisation to Arimidex or Arimidex-Placebo will be double-blind.

Conditions

• Progression-free Survival

Interventions

Type	Name	Description
DRUG	fulvestrant	Intramuscular injection on days 1, 15, and 29 and then once monthly until disease progression.
DRUG	anastrozole	Tablet, oral, once daily until disease progression.
DRUG	exemestane	Tablet, oral, once daily until disease progression.

Timeline

• Start date: 2008-12-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2009-07-23
• Last updated: 2011-08-29

Locations

2 sites across 1 country: South Korea