The Evaluation of the Efficacy and Tolerability of FASLODEX (fulvestrant) and AROMASIN (exemestane) in Hormone Receptor Positive Postmenopausal Women with Advanced Breast Cancer - EFECT
Study identifier:9238IL/0048
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Randomized, Double Blind, Multicenter Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEX™) vs. Exemestane (AROMASIN™) in Postmenopausal Women with Hormone Receptor Positive Advanced Breast Cancer with Disease Progression after Prior Non-Steroidal Aromatase Inhibitor (AI) Therapy
Medical condition
Locally advanced breast cancer
Phase
Phase 3
Healthy volunteers
No
Study drug
Fulvestrant, Exemestane
Sex
Female
Actual Enrollment
694
Study type
Interventional
Age
32 Years - 91 Years
Date
Study Start Date: 01 Aug 2003
Primary Completion Date: 01 Jun 2006
Study Completion Date: 01 Sept 2014
Study design
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Feb 2015 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1 Exemestane | Drug: Exemestane oral capsule Other Name: AROMASIN™ |
| Experimental: 2 Fulvestrant | Drug: Fulvestrant intramuscular injection Other Name: Faslodex Other Name: ZD9238 |
Contacts
Investigators
Principal Investigator
AstraZeneca Faslodex Medical Science Director
AstraZeneca
