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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00241449
Other study ID # 9238IL/0025
Secondary ID
Status Completed
Phase Phase 3
First received October 17, 2005
Last updated June 5, 2012
Start date November 1998
Est. completion date January 2012

Study information

Verified date June 2012
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 51
Est. completion date January 2012
Est. primary completion date March 2007
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Fulvestrant
intramuscular injection 250 mg
Tamoxifen
20 mg oral tablet

Locations

Country Name City State
Argentina Research Site Buenos Aires
Argentina Research Site Rosario
Australia Research Site Camperdown
Australia Research Site Concord
Australia Research Site Heidelburg
Australia Research Site Melbourne
Austria Research Site Salzburg
Austria Research Site Wien
Belgium Research Site Antwerpen
Belgium Research Site Haine-Saint Paul
Belgium Research Site Hasselt
Belgium Research Site Leuven
Brazil Research Site Belo Horizonte
Brazil Research Site Goiania
Brazil Research Site Sao Paulo
Canada Research Site Chicoutimi
Canada Research Site Edmonton Alberta
Canada Research Site Montreal
Canada Research Site Newmarket Ontario
Canada Research Site Ottawa Ontario
Canada Research Site Penticton British Columbia
Canada Research Site Saint John New Brunswick
Canada Research Site Toronto Ontario
Canada Research Site Weston Ontario
Canada Research Site York Ontario
Finland Research Site Kotka
Finland Research Site Kuopio
Finland Research Site Rovaniemi
France Research Site Clermont Ferrand
France Research Site Evreux
France Research Site Lyon
France Research Site Montpellier
France Research Site Pierre-Benite
France Research Site Rodez
France Research Site Rouen
France Research Site Tours
Germany Research Site Frankfurt
Germany Research Site Gottingen
Germany Research Site Rostock
Hungary Research Site Budapest
Hungary Research Site Pécs
Hungary Research Site Székesfehérvár
Hungary Research Site Szolnok
Ireland Research Site Dublin
Israel Research Site Ashkelon
Israel Research Site Haifa
Italy Research Site Bologna
Italy Research Site Brescia
Italy Research Site Forli
Italy Research Site Genova
Italy Research Site Milano
Italy Research Site Napoli
Italy Research Site Palermo
Italy Research Site Perugia
Italy Research Site Pisa
Italy Research Site Reggio Calabria
Italy Research Site Reggio Emilia
Italy Research Site Rozzano
Italy Research Site Sassari
Italy Research Site Trieste
Japan Research Site Amagasaki
Japan Research Site Fukuoka
Japan Research Site Kitakyusyu
Japan Research Site Kumamoto
Japan Research Site Matsuyama
Japan Research Site Nagoya
Japan Research Site Niigata
Japan Research Site Oita
Japan Research Site Osaka
Japan Research Site Saitama
Japan Research Site Sapporo
Japan Research Site Suita
Japan Research Site Tokyo
Mexico Research Site Guadalajara
Mexico Research Site Mexico, D.F.
Netherlands Research Site Den Haag
New Zealand Research Site Christchurch
New Zealand Research Site Palmerston North
Poland Research Site Bydgoszcz
Poland Research Site Krakow
Poland Research Site Szczecin
Poland Research Site Warszawa
Portugal Research Site Coimbra
Russian Federation Research Site Moscow
South Africa Research Site Cape Town
South Africa Research Site Johannesburg
South Africa Research Site Lyttelton Manor
Spain Research Site Badalona
Spain Research Site Guadalajara
Spain Research Site Madrid
Spain Research Site Málaga
Taiwan Research Site Kaohsiung
Taiwan Research Site Taichung
Taiwan Research Site Tainan
Taiwan Research Site Taipei
Taiwan Research Site Tao-Yuan
Turkey Research Site Istanbul
United Kingdom Research Site Belfast
United Kingdom Research Site Birmingham
United Kingdom Research Site Chelmsford
United Kingdom Research Site Chorley
United Kingdom Research Site Coventry
United Kingdom Research Site Huddersfield
United Kingdom Research Site Leeds
United Kingdom Research Site London
United Kingdom Research Site Luton
United Kingdom Research Site Manchester
United Kingdom Research Site Newcastle Upon Tyne
United Kingdom Research Site Northampton
United Kingdom Research Site Nottingham
United Kingdom Research Site Prescot
United Kingdom Research Site Telford
United Kingdom Research Site Whitehaven
United Kingdom Research Site Worthing
United Kingdom Research Site York
United States Research Site Austin Texas
United States Research Site Chicago Illinois
United States Research Site Columbus Ohio
United States Research Site Decatur Georgia
United States Research Site Detroit Michigan
United States Research Site Fountain Valley California
United States Research Site Galveston Texas
United States Research Site Gloucester Massachusetts
United States Research Site Houston Texas
United States Research Site La Jolla California
United States Research Site Lacey Washington
United States Research Site Little Rock Arkansas
United States Research Site Mason City Iowa
United States Research Site Meadowbrook Pennsylvania
United States Research Site Orange California
United States Research Site Providence Rhode Island
United States Research Site Richmond Virginia
United States Research Site San Antonio Texas
United States Research Site Seattle Washington
United States Research Site Shreveport Louisiana
United States Research Site Temple Texas
United States Research Site Venice Florida
United States Research Site Voorhees New Jersey
United States Research Site Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  Finland,  France,  Germany,  Hungary,  Ireland,  Israel,  Italy,  Japan,  Mexico,  Netherlands,  New Zealand,  Poland,  Portugal,  Russian Federation,  South Africa,  Spain,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to disease progression (TTP) It is considered that these results indicate that adequate data were available for obtaining clinically meaningful information for the primary efficacy endpoint of time to disease progression 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. Yes
Secondary Objective response rate (ORR) It is considered that these results indicate that adequate data were available for obtaining clinically meaningful information for the primary efficacy endpoint of time to disease progression 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. Yes
Secondary Duration of response (DoR) 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. Yes
Secondary Time to treatment failure (TTF) 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. Yes
Secondary Overall survival (OS) 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. Yes
Secondary Quality of Life (QOL) and Tolerability. 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. Yes
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