The Evaluation of the Efficacy and Tolerability of FASLODEX (Fulvestrant) and AROMASIN (Exemestane) in Hormone Receptor Positive Postmenopausal Women With Advanced Breast Cancer

NCT00065325 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 694

Last updated 2015-02-24

No results posted yet for this study

Summary

The purpose of this study is to compare the efficacy of Faslodex (fulvestrant) to Aromasin (exemestane) in hormone receptor positive postmenopausal women with advanced breast cancer. Patients will be treated until disease progression or until the investigator has determined that treatment is not in the best interest of the patient, whichever occurs first.

Conditions

Interventions

DRUG

Fulvestrant

intramuscular injection

DRUG

Exemestane

oral capsule

Sponsors & Collaborators

Principal Investigators

  • AstraZeneca Faslodex Medical Science Director, MD · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
32 Years
Max Age
91 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-08-31
Primary Completion
2006-06-30
Completion
2014-09-30

Countries

  • United States
  • Argentina
  • Belgium
  • Brazil
  • Canada
  • Denmark
  • France
  • Germany
  • Hungary
  • Israel
  • Russia
  • South Africa
  • Spain
  • Sweden
  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00065325 on ClinicalTrials.gov