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

Phase 3

Completed

• Conditions: Metastatic Breast Cancer; Locally Advanced Breast Cancer
• Interventions: Drug: Fulvestrant; Drug: Exemestane

• Registration Number: NCT00065325
• Lead Sponsor: AstraZeneca

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2003-07-21
• Study First Submitted QC: 2003-07-22
• Study First Posted: 2003-07-23
• Study Start: 2003-08
• Primary Completion: 2006-06
• Study Completion: 2014-09
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-23
• Last Update Posted: 2015-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 694

Inclusion Criteria

• Biopsy confirmation of Breast Cancer
• Breast Cancer has continued to grow after having received treatment with an aromatase inhibitor
• Postmenopausal women defined as a women who has stopped having menstrual periods
• Evidence of hormone sensitivity
• Written informed consent to participate in the trial

Exclusion Criteria

• Previous treatment with Faslodex (fulvestrant) or Aromasin (exemestane)
• Any hormonal therapy used to modify the course of an additional medical condition after prior treatment with a non-steroidal aromatase inhibitor
• Treatment with an investigational or non-approved drug within one month
• An existing serious disease, illness, or condition that will prevent participation or compliance with study procedures
• A history of allergies to any active or inactive ingredients of Faslodex or Exemestane (i.e. castor oil or Mannitol)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Fulvestrant	Fulvestrant
1	Exemestane	Exemestane

Primary Outcome Measures

Name	Time	Method
Time to disease progression (TTP)	after 580 Progression events accrued

Secondary Outcome Measures

Name	Time	Method
Overall survival	after 580 Progression events accrued
Objective response rate	after 580 Progression events accrued
Duration of response	after 580 Progression events accrued
Clinical Benefit	after 580 Progression events accrued
Quality of Life	after 580 Progression events accrued
PK	each visit
Safety and tolerability.	after 580 Progression events accrued

Trial Locations

Locations (1)

Research Site; 🇬🇧 Nottingham, United Kingdom