NCT01602380

A Global Study to Compare the Effects of Fulvestrant and Arimidex in a Subset of Patients With Breast Cancer.

A Randomised, Double-blind, Parallel-group, Multicentre, Phase III Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEX) 500 mg With Anastrozole (ARIMIDEX) 1 mg as Hormonal Treatment for Postmenopausal Women With Hormone Receptor-Positive Locally Advanced or Metastatic Breast Cancer Who Have Not Previously Been Treated With Any Hormonal Therapy.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 462 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: Female
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to compare how treatment with Fulvestrant (FASLODEX) or Anastrozole (ARIMIDEX) effects disease progression for women with locally advanced or metastatic breast cancer who have not had prior hormonal treatment.

Detailed description

A Randomised, Double-blind, Parallel-group, Multicentre, Phase III Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEX) 500 mg with Anastrozole (ARIMIDEX) 1 mg as Hormonal Treatment for Postmenopausal Women with Hormone Receptor-Positive Locally Advanced or Metastatic Breast Cancer Who Have Not Previously Been Treated With Any Hormonal Therapy.

Conditions

• Hormone Receptor Positive Breast Cancer

Interventions

Type	Name	Description
DRUG	faslodex 500mg	2 x intramuscular injections at day 1, 14, 28 and every 28 days thereafter
DRUG	arimidex 1mg	oral tablet 1 daily
DRUG	faslodex dummy	2 x intramuscular injections at day 1, 14, 28 and every 28 days thereafter
DRUG	arimidex dummy	oral tablet 1 daily

Timeline

• Start date: 2012-10-17
• Primary completion: 2016-04-11
• Completion: 2026-01-16
• First posted: 2012-05-21
• Last updated: 2026-02-27
• Results posted: 2017-05-17

Locations

118 sites across 20 countries: United States, Argentina, Brazil, Canada, China, Czechia, Italy, Japan, Mexico, Peru, Poland, Romania, Russia, Slovakia, South Africa, Spain, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom