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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Tamoxifen |
|
| 2 | Experimental | Fulvestrant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fulvestrant | Drug | intramuscular injection 250 mg |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Postmenopausal women. Written informed consent to participate in the study.
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| AstraZeneca Oncology Medical Science Director, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Little Rock | Arkansas | United States | |||
| Research Site |
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| Tamoxifen | Drug | 20 mg oral tablet |
|
|
| 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. |
| 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. |
| 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. |
| 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. |
| Fountain Valley |
| California |
| United States |
| Research Site | La Jolla | California | United States |
| Research Site | Orange | California | United States |
| Research Site | Washington D.C. | District of Columbia | United States |
| Research Site | Venice | Florida | United States |
| Research Site | Decatur | Georgia | United States |
| Research Site | Chicago | Illinois | United States |
| Research Site | Mason City | Iowa | United States |
| Research Site | Shreveport | Louisiana | United States |
| Research Site | Gloucester | Massachusetts | United States |
| Research Site | Detroit | Michigan | United States |
| Research Site | Voorhees Township | New Jersey | United States |
| Research Site | Columbus | Ohio | United States |
| Research Site | Meadowbrook | Pennsylvania | United States |
| Research Site | Providence | Rhode Island | United States |
| Research Site | Austin | Texas | United States |
| Research Site | Galveston | Texas | United States |
| Research Site | Houston | Texas | United States |
| Research Site | San Antonio | Texas | United States |
| Research Site | Temple | Texas | United States |
| Research Site | Richmond | Virginia | United States |
| Research Site | Lacey | Washington | United States |
| Research Site | Seattle | Washington | United States |
| Research Site | Buenos Aires | Argentina |
| Research Site | Rosario | Argentina |
| Research Site | Camperdown | Australia |
| Research Site | Concord | Australia |
| Research Site | Heidelburg | Australia |
| Research Site | Melbourne | Australia |
| Research Site | Salzburg | Austria |
| Research Site | Vienna | Austria |
| Research Site | Antwerp | Belgium |
| Research Site | Haine-Saint-Paul | Belgium |
| Research Site | Hasselt | Belgium |
| Research Site | Leuven | Belgium |
| Research Site | Belo Horizonte | Brazil |
| Research Site | Goiânia | Brazil |
| Research Site | São Paulo | Brazil |
| Research Site | Edmonton | Alberta | Canada |
| Research Site | Penticton | British Columbia | Canada |
| Research Site | Saint John | New Brunswick | Canada |
| Research Site | Newmarket | Ontario | Canada |
| Research Site | Ottawa | Ontario | Canada |
| Research Site | Toronto | Ontario | Canada |
| Research Site | Weston | Ontario | Canada |
| Research Site | York | Ontario | Canada |
| Research Site | Chicoutimi | Canada |
| Research Site | Montreal | Canada |
| Research Site | Kotka | Finland |
| Research Site | Kuopio | Finland |
| Research Site | Rovaniemi | Finland |
| Research Site | Clermont-Ferrand | France |
| Research Site | Évreux | France |
| Research Site | Lyon | France |
| Research Site | Montpellier | France |
| Research Site | Pierre-Bénite | France |
| Research Site | Rodez | France |
| Research Site | Rouen | France |
| Research Site | Tours | France |
| Research Site | Frankfurt | Germany |
| Research Site | Göttingen | Germany |
| Research Site | Rostock | Germany |
| Research Site | Budapest | Hungary |
| Research Site | Pécs | Hungary |
| Research Site | Székesfehérvár | Hungary |
| Research Site | Szolnok | Hungary |
| Research Site | Dublin | Ireland |
| Research Site | Ashkelon | Israel |
| Research Site | Haifa | Israel |
| Research Site | Bologna | Italy |
| Research Site | Brescia | Italy |
| Research Site | Forlì | Italy |
| Research Site | Genova | Italy |
| Research Site | Milan | Italy |
| Research Site | Naples | 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 | Italy |
| Research Site | Amagasaki | Japan |
| Research Site | Fukuoka | Japan |
| Research Site | Kitakyushu | Japan |
| Research Site | Kumamoto | Japan |
| Research Site | Matsuyama | Japan |
| Research Site | Nagoya | Japan |
| Research Site | Niigata | Japan |
| Research Site | Osaka | Japan |
| Research Site | Ōita | Japan |
| Research Site | Saitama | Japan |
| Research Site | Sapporo | Japan |
| Research Site | Suita | Japan |
| Research Site | Tokyo | Japan |
| Research Site | Guadalajara | Mexico |
| Research Site | Mexico City | Mexico |
| Research Site | The Hague | Netherlands |
| Research Site | Christchurch | New Zealand |
| Research Site | Palmerston North | New Zealand |
| Research Site | Bydgoszcz | Poland |
| Research Site | Krakow | Poland |
| Research Site | Szczecin | Poland |
| Research Site | Warsaw | Poland |
| Research Site | Coimbra | Portugal |
| Research Site | Moscow | Russia |
| Research Site | Cape Town | South Africa |
| Research Site | Johannesburg | South Africa |
| Research Site | Lyttelton Manor | South Africa |
| Research Site | Badalona | Spain |
| Research Site | Guadalajara | Spain |
| Research Site | Madrid | Spain |
| Research Site | Málaga | Spain |
| Research Site | Kaohsiung City | Taiwan |
| Research Site | Taichung | Taiwan |
| Research Site | Tainan | Taiwan |
| Research Site | Taipei | Taiwan |
| Research Site | Taoyuan | Taiwan |
| Research Site | Istanbul | Turkey (Türkiye) |
| 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 Kingdom |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077267 | Fulvestrant |
| D013629 | Tamoxifen |
| ID | Term |
|---|---|
| D004958 | Estradiol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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