A Trial Comparing the Efficacy and Tolerability of Faslodex With Nolvadex in Postmenopausal Women With Advanced Breast Cancer

NCT ID: NCT00241449

Last Updated: 2012-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-11-30

Study Completion Date

2012-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer Metastasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Tamoxifen

Group Type ACTIVE_COMPARATOR

Tamoxifen

Intervention Type DRUG

20 mg oral tablet

2

Fulvestrant

Group Type EXPERIMENTAL

Fulvestrant

Intervention Type DRUG

intramuscular injection 250 mg

Interventions

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Fulvestrant

intramuscular injection 250 mg

Intervention Type DRUG

Tamoxifen

20 mg oral tablet

Intervention Type DRUG

Other Intervention Names

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Faslodex ZD9238 Nolvadex

Eligibility Criteria

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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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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AstraZeneca Oncology Medical Science Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Little Rock, Arkansas, United States

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Fountain Valley, California, United States

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La Jolla, California, United States

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Orange, California, United States

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Washington D.C., District of Columbia, United States

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Venice, Florida, United States

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Decatur, Georgia, United States

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Chicago, Illinois, United States

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Mason City, Iowa, United States

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Shreveport, Louisiana, United States

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Gloucester, Massachusetts, United States

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Detroit, Michigan, United States

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Voorhees Township, New Jersey, United States

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Columbus, Ohio, United States

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Meadowbrook, Pennsylvania, United States

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Providence, Rhode Island, United States

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Austin, Texas, United States

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Galveston, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Temple, Texas, United States

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Richmond, Virginia, United States

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Lacey, Washington, United States

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Seattle, Washington, United States

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Buenos Aires, , Argentina

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Rosario, , Argentina

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Camperdown, , Australia

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Concord, , Australia

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Heidelburg, , Australia

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Melbourne, , Australia

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Salzburg, , Austria

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Vienna, , Austria

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Antwerp, , Belgium

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Haine-Saint-Paul, , Belgium

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Hasselt, , Belgium

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Leuven, , Belgium

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Belo Horizonte, , Brazil

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Goiânia, , Brazil

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São Paulo, , Brazil

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Edmonton, Alberta, Canada

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Penticton, British Columbia, Canada

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Saint John, New Brunswick, Canada

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Newmarket, Ontario, Canada

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Weston, Ontario, Canada

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York, Ontario, Canada

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Chicoutimi, , Canada

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Montreal, , Canada

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Kotka, , Finland

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Kuopio, , Finland

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Rovaniemi, , Finland

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Clermont-Ferrand, , France

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Évreux, , France

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Lyon, , France

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Montpellier, , France

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Pierre-Bénite, , France

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Rodez, , France

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Rouen, , France

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Tours, , France

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Frankfurt, , Germany

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Göttingen, , Germany

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Rostock, , Germany

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Budapest, , Hungary

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Pécs, , Hungary

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Székesfehérvár, , Hungary

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Szolnok, , Hungary

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Dublin, , Ireland

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Ashkelon, , Israel

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Haifa, , Israel

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Bologna, , Italy

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Brescia, , Italy

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Forlì, , Italy

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Genova, , Italy

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Milan, , Italy

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Napoli, , Italy

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Palermo, , Italy

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Perugia, , Italy

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Pisa, , Italy

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Reggio Calabria, , Italy

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Reggio Emilia, , Italy

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Rozzano, , Italy

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Sassari, , Italy

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Trieste, , Italy

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Amagasaki, , Japan

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Fukuoka, , Japan

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Kitakyushu, , Japan

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Kumamoto, , Japan

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Matsuyama, , Japan

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Nagoya, , Japan

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Niigata, , Japan

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Osaka, , Japan

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Ōita, , Japan

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Saitama, , Japan

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Sapporo, , Japan

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Suita, , Japan

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Tokyo, , Japan

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Guadalajara, , Mexico

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Mexico City, , Mexico

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The Hague, , Netherlands

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Christchurch, , New Zealand

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Palmerston North, , New Zealand

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Bydgoszcz, , Poland

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Krakow, , Poland

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Szczecin, , Poland

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Warsaw, , Poland

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Coimbra, , Portugal

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Moscow, , Russia

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Cape Town, , South Africa

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Johannesburg, , South Africa

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Lyttelton Manor, , South Africa

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Badalona, , Spain

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Guadalajara, , Spain

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Madrid, , Spain

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Málaga, , Spain

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Kaohsiung City, , Taiwan

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Taichung, , Taiwan

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Tainan City, , Taiwan

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Taipei, , Taiwan

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Taoyuan District, , Taiwan

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Istanbul, , Turkey (Türkiye)

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Belfast, , United Kingdom

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Birmingham, , United Kingdom

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Chelmsford, , United Kingdom

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Chorley, , United Kingdom

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Coventry, , United Kingdom

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Huddersfield, , United Kingdom

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Leeds, , United Kingdom

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London, , United Kingdom

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Luton, , United Kingdom

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Manchester, , United Kingdom

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Newcastle upon Tyne, , United Kingdom

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Northampton, , United Kingdom

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Nottingham, , United Kingdom

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Prescot, , United Kingdom

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Telford, , United Kingdom

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Whitehaven, , United Kingdom

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Worthing, , United Kingdom

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York, , United Kingdom

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Countries

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

Other Identifiers

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9238IL/0025

Identifier Type: -

Identifier Source: org_study_id

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