Comparison of Fulvestrant (FASLODEX™) 250 mg and 500 mg in Postmenopausal Women with Oestrogen Receptor positive Advanced Breast Cancer Progressing or Relapsing after Previous Endocrine Therapy. - CONFIRM

Study identifier:D6997C00002

ClinicalTrials.gov identifier:NCT00099437

EudraCT identifier:2004-002371-16

CTIS identifier:N/A

Recruitment Complete

Official Title

A Randomised, Double-Blind, Parallel-group, Multicentre, Phase III Study Comparing the Efficacy and Tolerability of Fulvestrant (FASLODEX™) 500 mg with Fulvestrant (FASLODEX™) 250 mg in Postmenopausal Women with Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing after Previous Endocrine Therapy

Medical condition

Breast Cancer

Phase

Phase 3

Healthy volunteers

No

Study drug

Fulvestrant

Sex

Female

Actual Enrollment

736

Study type

Interventional

Age

45 Years - 130 Years

Date

Study Start Date: 13 Feb 2005
Primary Completion Date: 27 Feb 2009
Estimated Study Completion Date: 31 Mar 2025

Study design

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

Verification:

Verified 01 Jul 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria