A global study to compare the effects of Fulvestrant and arimidex in a subset of patients with breast cancer. - FALCON

Study identifier:D699BC00001

ClinicalTrials.gov identifier:NCT01602380

EudraCT identifier:2011-006326-24

CTIS identifier:N/A

Recruitment Complete

Official Title

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.

Medical condition

hormone receptor positive breast cancer

Phase

Phase 3

Healthy volunteers

No

Study drug

faslodex 500mg, arimidex 1mg, faslodex dummy, arimidex dummy

Sex

Female

Actual Enrollment

462

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 17 Oct 2012
Primary Completion Date: 11 Apr 2016
Estimated Study Completion Date: 31 Dec 2024

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Aug 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria