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| ID | Type | Description | Link |
|---|---|---|---|
| EFECT | |||
| D6997C00048 |
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The purpose of this study is to compare the efficacy of Faslodex (fulvestrant) to Aromasin (exemestane) in hormone receptor positive 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 | Exemestane |
|
| 2 | Experimental | Fulvestrant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fulvestrant | Drug | intramuscular injection |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to disease progression (TTP) | after 580 Progression events accrued |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | after 580 Progression events accrued | |
| Overall survival | after 580 Progression events accrued | |
| Duration of response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AstraZeneca Faslodex Medical Science Director, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Birmingham | Alabama | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39046616 | Derived | Arizmendi C, Zhu Y, Khan M, Gable J, Reeve BB, King-Kallimanis B, Bell J. The FACT-GP5 as a global tolerability measure: responsiveness and robustness to missing assessments. Qual Life Res. 2024 Oct;33(10):2869-2880. doi: 10.1007/s11136-024-03740-x. Epub 2024 Jul 24. |
| Label | URL |
|---|---|
| MEDLINEplus related topics: Breast Cancer | View source |
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| Exemestane | Drug | oral capsule |
|
|
| after 580 Progression events accrued |
| Clinical Benefit | after 580 Progression events accrued |
| Quality of Life | after 580 Progression events accrued |
| PK | each visit |
| Safety and tolerability. | after 580 Progression events accrued |
| Arcadia |
| California |
| United States |
| Research Site | Fountain Valley | California | United States |
| Research Site | Laverne | California | United States |
| Research Site | Long Beach | California | United States |
| Research Site | Santa Rosa | California | United States |
| Research Site | Torrington | Connecticut | United States |
| Research Site | Washington D.C. | District of Columbia | United States |
| Research Site | Boca Raton | Florida | United States |
| Research Site | Gainesville | Florida | United States |
| Research Site | Jacksonville | Florida | United States |
| Research Site | Miami | Florida | United States |
| Research Site | New Port Richey | Florida | United States |
| Research Site | Pensacola | Florida | United States |
| Research Site | Athens | Georgia | United States |
| Research Site | Chicago | Illinois | United States |
| Research Site | Harvey | Illinois | United States |
| Research Site | Springfield | Illinois | United States |
| Research Site | Iowa City | Iowa | United States |
| Research Site | Overland Park | Kansas | United States |
| Research Site | Baton Rouge | Louisiana | United States |
| Research Site | Metairie | Louisiana | United States |
| Research Site | New Orleans | Louisiana | United States |
| Research Site | Shreveport | Louisiana | United States |
| Research Site | Bangor | Maine | United States |
| Research Site | Baltimore | Maryland | United States |
| Research Site | Frederick | Maryland | United States |
| Research Site | Kalamazoo | Michigan | United States |
| Research Site | Royal Oak | Michigan | United States |
| Research Site | Saint Joseph | Michigan | United States |
| Research Site | Hooksett | New Hampshire | United States |
| Research Site | Livingston | New Jersey | United States |
| Research Site | Voorhees Township | New Jersey | United States |
| Research Site | Albuquerque | New Mexico | United States |
| Research Site | Charlotte | North Carolina | United States |
| Research Site | Durham | North Carolina | United States |
| Research Site | Canton | Ohio | United States |
| Research Site | Hershey | Pennsylvania | United States |
| Research Site | Lancaster | Pennsylvania | United States |
| Research Site | Langhorne | Pennsylvania | United States |
| Research Site | Pittsburgh | Pennsylvania | United States |
| Research Site | Providence | Rhode Island | United States |
| Research Site | Columbia | South Carolina | United States |
| Research Site | Greenville | South Carolina | United States |
| Research Site | Spartenburg | South Carolina | United States |
| Research Site | Austin | Texas | United States |
| Research Site | Dallas | Texas | United States |
| Research Site | Houston | Texas | United States |
| Research Site | San Antonio | Texas | United States |
| Research Site | Burlington | Vermont | United States |
| Research Site | Richmond | Virginia | United States |
| Research Site | Buenos Aires | Buenos Aires | Argentina |
| Research Site | Ciudad de Buenos Aires | Buenos Aires | Argentina |
| Research Site | Mar del Plata | Buenos Aires | Argentina |
| Research Site | Rosario | Santa Fe Province | Argentina |
| Research Site | Brussels | Belgium | Belgium |
| Research Site | Leuven | Belgium | Belgium |
| Research Site | Ottignies | Belgium | Belgium |
| Research Site | Wilrijk | Belgium | Belgium |
| Research Site | Goiânia | Goiás | Brazil |
| Research Site | Rio de Janeiro | Rio de Janeiro | Brazil |
| Research Site | Porto Alegre | Rio Grande do Sul | Brazil |
| Research Site | São Paulo | São Paulo | Brazil |
| Research Site | Edmonton | Alberta | Canada |
| Research Site | Penticton | British Columbia | Canada |
| Research Site | Vancouver | British Columbia | Canada |
| Research Site | Winnipeg | Manitoba | Canada |
| Research Site | St. John's | Newfoundland and Labrador | Canada |
| Research Site | Kingston | Ontario | Canada |
| Research Site | London | Ontario | Canada |
| Research Site | Newmarket | Ontario | Canada |
| Research Site | Oshawa | Ontario | Canada |
| Research Site | Ottawa | Ontario | Canada |
| Research Site | Sault Ste. Marie | Ontario | Canada |
| Research Site | Toronto | Ontario | Canada |
| Research Site | Windsor | Ontario | Canada |
| Research Site | Montreal | Quebec | Canada |
| Research Site | Québec | Quebec | Canada |
| Research Site | Aalborg | Denmark |
| Research Site | Herning | Denmark |
| Research Site | Hillerød | Denmark |
| Research Site | København Ø | Denmark |
| Research Site | Roskilde | Denmark |
| Research Site | Sønderborg | Denmark |
| Research Site | Bordeaux | France |
| Research Site | Lille | France |
| Research Site | Montpellier | France |
| Research Site | Vandœuvre-lès-Nancy | France |
| Research Site | Augsburg | Germany |
| Research Site | Berlin | Germany |
| Research Site | Hamburg | Germany |
| Research Site | Regensburg | Germany |
| Research Site | Budapest | Hungary |
| Research Site | Debrecen | Hungary |
| Research Site | Szeged | Hungary |
| Research Site | Haifa | Israel |
| Research Site | Tel Aviv | Israel |
| Research Site | Obninsk | Kaluga Oblast | Russia |
| Research Site | Moscow | Russia |
| Research Site | Saint Petersburg | Russia |
| Research Site | Klerksdorp | North West | South Africa |
| Research Site | Bloemfontein | South Africa | South Africa |
| Research Site | Cape Town | South Africa | South Africa |
| Research Site | Johannesburg | South Africa | South Africa |
| Research Site | Port Elizabeth | South Africa | South Africa |
| Research Site | Pretoria | South Africa | South Africa |
| Research Site | Seville | Andalusia | Spain |
| Research Site | Barcelona | Catalonia | Spain |
| Research Site | Hospitalet Dellobregat(barcelo | Catalonia | Spain |
| Research Site | Terrassa(barcelona) | Catalonia | Spain |
| Research Site | Madrid | Madrid | Spain |
| Research Site | Valencia | Valencia | Spain |
| Research Site | Halmstad | Sweden |
| Research Site | Lund | Sweden |
| Research Site | Stockholm | Sweden |
| Research Site | Uppsala | Sweden |
| Research Site | Nottingham | United Kingdom |
| MEDLINEplus related topics: Cancer (General) | View source |
| MEDLINEplus related topics: Cancer--Living with Cancer | View source |
| CSR-9238IL-0048.pdf | View source |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000077267 | Fulvestrant |
| C056516 | exemestane |
| 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 |
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