Study of Faslodex with or without concomitant Arimidex versus Exemestane following progression on Non-steroidal Aromatase Inhibitors (NSAI)

Study identifier:9238UK/0005

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A partially-blind phase III randomised trial of Fulvestrant (Faslodex) with or without concomitant Anastrozole (Arimidex) compared with exemestane in postmenopausal women with ER+ve locally advanced/metastatic breast cancer following progression on non-steroidal aromatase inhibitors

Medical condition

Progression-free survival

Phase

Phase 3

Healthy volunteers

Study drug

fulvestrant, anastrozole, exemestane

Sex

Female

Actual Enrollment

Study type

Interventional

Age

18 Years +

Date

Study Start Date: 01 Dec 2008

Primary Completion Date: 01 Jun 2011

Study Completion Date: 01 Jun 2011

Study design

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

Verification:

Verified 01 Aug 2011 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Seoul, Republic of Korea

Location

Research Site

Ilsan, Republic of Korea

Arms	Assigned Interventions
Experimental: 1 fulvestrant and anastrozole	Drug: fulvestrant Intramuscular injection on days 1, 15, and 29 and then once monthly until disease progression. Other Name: Faslodex Drug: anastrozole Tablet, oral, once daily until disease progression. Other Name: Arimidex
Experimental: 2 fulvestrant and placebo	Drug: fulvestrant Intramuscular injection on days 1, 15, and 29 and then once monthly until disease progression. Other Name: Faslodex
Active Comparator: 3 exemestane alone	Drug: exemestane Tablet, oral, once daily until disease progression. Other Name: Aromasin

"There is no result for the study"

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Korea Clinical Study Information

82 2 2188 0800

Investigators

Principal Investigator

Young-Huck Im

Professor(Samsung Medical Center)

Study of Faslodex with or without concomitant Arimidex versus Exemestane following progression on Non-steroidal Aromatase Inhibitors (NSAI)

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Documents available

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator