Clinical trial NCT00274469: A Clinical Trial to Compare Efficacy and Tolerability of Faslodex With Arimidex in Patients With Advanced Breast Cancer
Official title: A Randomized, Open-Label, Parallel-Group, Multicentre, Phase II Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEX™) 500 mg With Anastrozole (ARIMIDEX™) 1 mg as First Line Hormonal Treatment for Postmenopausal Women With Hormone Receptor Positive Advanced Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Breast Cancer
Keywords: oncology
cancer
breast cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-01-11
Enrollment: 205
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy and tolerability of Faslodex (fulvestrant) with Arimidex (anastrozole) in postmenopausal women with hormone receptor positive advanced breast cancer.


Eligibility criteria: Inclusion Criteria:

* Confirmed hormone receptor positive advanced breast cancer, postmenopausal women

Exclusion Criteria:

* Previous treatment for advanced breast cancer (previous treatment for early breast cancer is allowed).

Primary outcomes:
measure: Clinical Benefit Rate
timeFrame: From randomisation to data cut off (DCO) for primary analysis. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007 respectively. The DCO for primary analysis was on 10th Jan 2008, 6 months after the last patient was enrolled.
Secondary outcomes:
measure: Objective Response Rate
timeFrame: From randomisation to data cut off (DCO) for primary analysis. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007 respectively. The DCO for primary analysis was on 10th Jan 2008, 6 months after the last patient was enrolled.
measure: Time to Progression
timeFrame: From randomisation to data cut off (DCO) for primary analysis. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007 respectively. The DCO for primary analysis was on 10th Jan 2008, 6 months after the last patient was enrolled.
measure: Time to Treatment Failure
timeFrame: From randomisation to data cut off (DCO) for 75% treatment failure. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007. The DCO for 75% treatment failure was on 26 Mar 2010, 32 months after the last patient was enrolled.
measure: Time to Progression (Investigator Assessed)
timeFrame: From randomisation to data cut off (DCO) for 75% treatment failure. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007. The DCO for 75% treatment failure was on 26 Mar 2010, 32 months after the last patient was enrolled.
Other outcomes:
Locations:
city: Frederick
country: United States
facility: Research Site
state: Maryland
city: Saint Louis
country: United States
facility: Research Site
state: Missouri
city: Teaneck
country: United States
facility: Research Site
state: New Jersey
city: Austin
country: United States
facility: Research Site
state: Texas
city: Duncanville
country: United States
facility: Research Site
state: Texas
city: Barretos
country: Brazil
facility: Research Site
city: Belo Horizonte
country: Brazil
facility: Research Site
city: Goiânia
country: Brazil
facility: Research Site
city: Jaú
country: Brazil
facility: Research Site
city: Rio de Janeiro
country: Brazil
facility: Research Site
city: Sao Paulo
country: Brazil
facility: Research Site
city: Blagoevgrad
country: Bulgaria
facility: Research Site
city: Plovdiv
country: Bulgaria
facility: Research Site
city: Shumen
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Varna
country: Bulgaria
facility: Research Site
city: Veliko Tarnovo
country: Bulgaria
facility: Research Site
city: Vratza
country: Bulgaria
facility: Research Site
city: Brno
country: Czechia
facility: Research Site
city: Brno
country: Czechia
facility: Research Site
city: Jicin
country: Czechia
facility: Research Site
city: Ostrava
country: Czechia
facility: Research Site
city: Praha 4
country: Czechia
facility: Research Site
city: Usti nad Labem
country: Czechia
facility: Research Site
city: Nice
country: France
facility: Research Site
city: Poitiers
country: France
facility: Research Site
city: Saint-cloud
country: France
facility: Research Site
city: Napoli
country: Italy
facility: Research Site
city: Sassari
country: Italy
facility: Research Site
city: Kraków
country: Poland
facility: Research Site
city: Olsztyn
country: Poland
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Córdoba
country: Spain
facility: Research Site
city: Lérida
country: Spain
facility: Research Site
city: Pontevedra
country: Spain
facility: Research Site
city: Derby
country: United Kingdom
facility: Research Site
city: Dundee
country: United Kingdom
facility: Research Site
city: Edinburgh
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Faslodex Medical Science Director, MD
role: STUDY_DIRECTOR
References: