Clinical trial NCT00241449: A Trial Comparing the Efficacy and Tolerability of Faslodex With Nolvadex in Postmenopausal Women With Advanced Breast Cancer
Official title: A Double-blind, Randomized, Multicentre Trial Comparing the Efficacy and Tolerability of 250mg of Faslodex (Long Acting ICI 182,780) With 20mg of Nolvadex (Tamoxifen) in Postmenopausal Women With Advanced Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Metastasis
Keywords: Locally advanced breast cancer or metastatic breast cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-10-19
Enrollment: 51
Sex: FEMALE
Standard ages: CHILD
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 of Faslodex (fulvestrant) to Nolvadex (tamoxifen) as first-line treatment for 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.


Eligibility criteria: Inclusion Criteria:

* Biopsy confirmation of breast cancer. Evidence of breast cancer that is not considered amenable to curative treatment.

Postmenopausal women. Written informed consent to participate in the study.

Exclusion Criteria:

* Previous treatment with hormonal therapy unless that therapy was tamoxifen for adjuvant breast cancer. The use of tamoxifen must have ceased at least one year before this study.

Previous treatment with Faslodex. Any existing serious disease, illness, or condition that will prevent participation or compliance with the study procedures.

Treatment with an investigational or non-approved drug within one month of then start of the study.

Primary outcomes:
measure: Time to disease progression (TTP)
timeFrame: At the time of data cut-off for this trial, the median overall duration of follow-up was 441 days, with a total of 434 (73.9%) randomised patients, including 47 patients from Japanese centres having progressed.
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: At the time of data cut-off for this trial, the median overall duration of follow-up was 441 days, with a total of 434 (73.9%) randomised patients, including 47 patients from Japanese centres having progressed.
measure: Duration of response (DoR)
timeFrame: At the time of data cut-off for this trial, the median overall duration of follow-up was 441 days, with a total of 434 (73.9%) randomised patients, including 47 patients from Japanese centres having progressed.
measure: Time to treatment failure (TTF)
timeFrame: At the time of data cut-off for this trial, the median overall duration of follow-up was 441 days, with a total of 434 (73.9%) randomised patients, including 47 patients from Japanese centres having progressed.
measure: Overall survival (OS)
timeFrame: At the time of data cut-off for this trial, the median overall duration of follow-up was 441 days, with a total of 434 (73.9%) randomised patients, including 47 patients from Japanese centres having progressed.
measure: Quality of Life (QOL) and Tolerability.
timeFrame: At the time of data cut-off for this trial, the median overall duration of follow-up was 441 days, with a total of 434 (73.9%) randomised patients, including 47 patients from Japanese centres having progressed.
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Research Site
state: Arkansas
city: Fountain Valley
country: United States
facility: Research Site
state: California
city: La Jolla
country: United States
facility: Research Site
state: California
city: Orange
country: United States
facility: Research Site
state: California
city: Washington
country: United States
facility: Research Site
state: District of Columbia
city: Venice
country: United States
facility: Research Site
state: Florida
city: Decatur
country: United States
facility: Research Site
state: Georgia
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Mason City
country: United States
facility: Research Site
state: Iowa
city: Shreveport
country: United States
facility: Research Site
state: Louisiana
city: Gloucester
country: United States
facility: Research Site
state: Massachusetts
city: Detroit
country: United States
facility: Research Site
state: Michigan
city: Voorhees
country: United States
facility: Research Site
state: New Jersey
city: Columbus
country: United States
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state: Ohio
city: Meadowbrook
country: United States
facility: Research Site
state: Pennsylvania
city: Providence
country: United States
facility: Research Site
state: Rhode Island
city: Austin
country: United States
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state: Texas
city: Galveston
country: United States
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state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
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state: Texas
city: Temple
country: United States
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state: Texas
city: Richmond
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state: Virginia
city: Lacey
country: United States
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state: Washington
city: Seattle
country: United States
facility: Research Site
state: Washington
city: Buenos Aires
country: Argentina
facility: Research Site
city: Rosario
country: Argentina
facility: Research Site
city: Camperdown
country: Australia
facility: Research Site
city: Concord
country: Australia
facility: Research Site
city: Heidelburg
country: Australia
facility: Research Site
city: Melbourne
country: Australia
facility: Research Site
city: Salzburg
country: Austria
facility: Research Site
city: Wien
country: Austria
facility: Research Site
city: Antwerpen
country: Belgium
facility: Research Site
city: Haine-Saint Paul
country: Belgium
facility: Research Site
city: Hasselt
country: Belgium
facility: Research Site
city: Leuven
country: Belgium
facility: Research Site
city: Belo Horizonte
country: Brazil
facility: Research Site
city: Goiania
country: Brazil
facility: Research Site
city: Sao Paulo
country: Brazil
facility: Research Site
city: Edmonton
country: Canada
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state: Alberta
city: Penticton
country: Canada
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state: British Columbia
city: Saint John
country: Canada
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state: New Brunswick
city: Newmarket
country: Canada
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state: Ontario
city: Ottawa
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Weston
country: Canada
facility: Research Site
state: Ontario
city: York
country: Canada
facility: Research Site
state: Ontario
city: Chicoutimi
country: Canada
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city: Montreal
country: Canada
facility: Research Site
city: Kotka
country: Finland
facility: Research Site
city: Kuopio
country: Finland
facility: Research Site
city: Rovaniemi
country: Finland
facility: Research Site
city: Clermont Ferrand
country: France
facility: Research Site
city: Evreux
country: France
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city: Lyon
country: France
facility: Research Site
city: Montpellier
country: France
facility: Research Site
city: Pierre-Benite
country: France
facility: Research Site
city: Rodez
country: France
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city: Rouen
country: France
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city: Tours
country: France
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city: Frankfurt
country: Germany
facility: Research Site
city: Gottingen
country: Germany
facility: Research Site
city: Rostock
country: Germany
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city: Budapest
country: Hungary
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city: Pécs
country: Hungary
facility: Research Site
city: Szolnok
country: Hungary
facility: Research Site
city: Székesfehérvár
country: Hungary
facility: Research Site
city: Dublin
country: Ireland
facility: Research Site
city: Ashkelon
country: Israel
facility: Research Site
city: Haifa
country: Israel
facility: Research Site
city: Bologna
country: Italy
facility: Research Site
city: Brescia
country: Italy
facility: Research Site
city: Forli
country: Italy
facility: Research Site
city: Genova
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Napoli
country: Italy
facility: Research Site
city: Palermo
country: Italy
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city: Perugia
country: Italy
facility: Research Site
city: Pisa
country: Italy
facility: Research Site
city: Reggio Calabria
country: Italy
facility: Research Site
city: Reggio Emilia
country: Italy
facility: Research Site
city: Rozzano
country: Italy
facility: Research Site
city: Sassari
country: Italy
facility: Research Site
city: Trieste
country: Italy
facility: Research Site
city: Amagasaki
country: Japan
facility: Research Site
city: Fukuoka
country: Japan
facility: Research Site
city: Kitakyusyu
country: Japan
facility: Research Site
city: Kumamoto
country: Japan
facility: Research Site
city: Matsuyama
country: Japan
facility: Research Site
city: Nagoya
country: Japan
facility: Research Site
city: Niigata
country: Japan
facility: Research Site
city: Oita
country: Japan
facility: Research Site
city: Osaka
country: Japan
facility: Research Site
city: Saitama
country: Japan
facility: Research Site
city: Sapporo
country: Japan
facility: Research Site
city: Suita
country: Japan
facility: Research Site
city: Tokyo
country: Japan
facility: Research Site
city: Guadalajara
country: Mexico
facility: Research Site
city: Mexico, D.F.
country: Mexico
facility: Research Site
city: Den Haag
country: Netherlands
facility: Research Site
city: Christchurch
country: New Zealand
facility: Research Site
city: Palmerston North
country: New Zealand
facility: Research Site
city: Bydgoszcz
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Szczecin
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Coimbra
country: Portugal
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Cape Town
country: South Africa
facility: Research Site
city: Johannesburg
country: South Africa
facility: Research Site
city: Lyttelton Manor
country: South Africa
facility: Research Site
city: Badalona
country: Spain
facility: Research Site
city: Guadalajara
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Málaga
country: Spain
facility: Research Site
city: Kaohsiung
country: Taiwan
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Tainan
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Tao-Yuan
country: Taiwan
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
city: Belfast
country: United Kingdom
facility: Research Site
city: Birmingham
country: United Kingdom
facility: Research Site
city: Chelmsford
country: United Kingdom
facility: Research Site
city: Chorley
country: United Kingdom
facility: Research Site
city: Coventry
country: United Kingdom
facility: Research Site
city: Huddersfield
country: United Kingdom
facility: Research Site
city: Leeds
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Luton
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
city: Newcastle Upon Tyne
country: United Kingdom
facility: Research Site
city: Northampton
country: United Kingdom
facility: Research Site
city: Nottingham
country: United Kingdom
facility: Research Site
city: Prescot
country: United Kingdom
facility: Research Site
city: Telford
country: United Kingdom
facility: Research Site
city: Whitehaven
country: United Kingdom
facility: Research Site
city: Worthing
country: United Kingdom
facility: Research Site
city: York
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Oncology Medical Science Director, MD
role: STUDY_DIRECTOR
References: