Metastatic Breast Cancer Clinical Trial
— EFECTOfficial title:
A Randomized, Double Blind, Multicenter Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEX™) vs. Exemestane (AROMASIN™) in Postmenopausal Women With Hormone Receptor Positive Advanced Breast Cancer With Disease Progression After Prior Non-Steroidal Aromatase Inhibitor (AI) Therapy
| Verified date | February 2015 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 694 |
| Est. completion date | September 2014 |
| Est. primary completion date | June 2006 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 32 Years to 91 Years |
| Eligibility |
Inclusion Criteria: - Biopsy confirmation of Breast Cancer - Breast Cancer has continued to grow after having received treatment with an aromatase inhibitor - Postmenopausal women defined as a women who has stopped having menstrual periods - Evidence of hormone sensitivity - Written informed consent to participate in the trial Exclusion Criteria: - Previous treatment with Faslodex (fulvestrant) or Aromasin (exemestane) - Any hormonal therapy used to modify the course of an additional medical condition after prior treatment with a non-steroidal aromatase inhibitor - Treatment with an investigational or non-approved drug within one month - An existing serious disease, illness, or condition that will prevent participation or compliance with study procedures - A history of allergies to any active or inactive ingredients of Faslodex or Exemestane (i.e. castor oil or Mannitol) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Research Site | 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 |
| Belgium | Research Site | Brussels | |
| Belgium | Research Site | Leuven | |
| Belgium | Research Site | Ottignies | |
| Belgium | Research Site | Wilrijk | |
| Brazil | Research Site | Goiania | GO |
| Brazil | Research Site | Porto Alegre | RS |
| Brazil | Research Site | Rio de Janeiro | RJ |
| Brazil | Research Site | Sao Paulo | SP |
| Canada | Research Site | Edmonton | Alberta |
| Canada | Research Site | Kingston | Ontario |
| Canada | Research Site | London | Ontario |
| Canada | Research Site | Montreal | Quebec |
| Canada | Research Site | Newmarket | Ontario |
| Canada | Research Site | Oshawa | Ontario |
| Canada | Research Site | Ottawa | Ontario |
| Canada | Research Site | Penticton | British Columbia |
| Canada | Research Site | Quebec | |
| Canada | Research Site | Sault Ste. Marie | Ontario |
| Canada | Research Site | St. John's | Newfoundland and Labrador |
| Canada | Research Site | Toronto | Ontario |
| Canada | Research Site | Vancouver | British Columbia |
| Canada | Research Site | Windsor | Ontario |
| Canada | Research Site | Winnipeg | Manitoba |
| Denmark | Research Site | Alborg | |
| Denmark | Research Site | Herning | |
| Denmark | Research Site | Hillerod | |
| Denmark | Research Site | Kobenhavn O | |
| Denmark | Research Site | Roskilde | |
| Denmark | Research Site | Sonderborg | |
| France | Research Site | Bordeaux Cedex | |
| France | Research Site | Lille Cedex | |
| France | Research Site | Montpellier Cedex 5 | |
| France | Research Site | Vandoeuvre Les Nancy | |
| Germany | Research Site | Augsburg | |
| Germany | Research Site | Berlin | |
| Germany | Research Site | Hamburg | |
| Germany | Research Site | Regensburg | |
| Hungary | Research Site | Budapest | |
| Hungary | Research Site | Debrecen | |
| Hungary | Research Site | Szeged | |
| Israel | Research Site | Haifa | |
| Israel | Research Site | Tel-aviv | |
| Russian Federation | Research Site | Moscow | |
| Russian Federation | Research Site | Obninsk | Kaluga Region |
| Russian Federation | Research Site | St-petersburg | |
| South Africa | Research Site | Bloemfontein | |
| South Africa | Research Site | Cape Town | |
| South Africa | Research Site | Johannesburg | |
| South Africa | Research Site | Klerksdorp | North West Province |
| South Africa | Research Site | Port Elizabeth | |
| South Africa | Research Site | Pretoria | |
| Spain | Research Site | Barcelona | Cataluna |
| Spain | Research Site | Hospitalet Dellobregat(barcelo | Cataluna |
| Spain | Research Site | Madrid | Comunidad de Madrid |
| Spain | Research Site | Sevilla | Andalucia |
| Spain | Research Site | Terrassa(barcelona) | Cataluna |
| Spain | Research Site | Valencia | Comunidad Valenciana |
| Sweden | Research Site | Halmstad | |
| Sweden | Research Site | Lund | |
| Sweden | Research Site | Stockholm | |
| Sweden | Research Site | Uppsala | |
| United Kingdom | Research Site | Nottingham | |
| United States | Research Site | Albuquerque | New Mexico |
| United States | Research Site | Arcadia | California |
| United States | Research Site | Athens | Georgia |
| United States | Research Site | Austin | Texas |
| United States | Research Site | Baltimore | Maryland |
| United States | Research Site | Bangor | Maine |
| United States | Research Site | Baton Rouge | Louisiana |
| United States | Research Site | Birmingham | Alabama |
| United States | Research Site | Boca Raton | Florida |
| United States | Research Site | Burlington | Vermont |
| United States | Research Site | Canton | Ohio |
| United States | Research Site | Charlotte | North Carolina |
| United States | Research Site | Chicago | Illinois |
| United States | Research Site | Columbia | South Carolina |
| United States | Research Site | Dallas | Texas |
| United States | Research Site | Durham | North Carolina |
| United States | Research Site | Fountain Valley | California |
| United States | Research Site | Frederick | Maryland |
| United States | Research Site | Gainesville | Florida |
| United States | Research Site | Greenville | South Carolina |
| United States | Research Site | Harvey | Illinois |
| United States | Research Site | Hershey | Pennsylvania |
| United States | Research Site | Hooksett | New Hampshire |
| United States | Research Site | Houston | Texas |
| United States | Research Site | Iowa City | Iowa |
| United States | Research Site | Jacksonville | Florida |
| United States | Research Site | Kalamazoo | Michigan |
| United States | Research Site | Lancaster | Pennsylvania |
| United States | Research Site | Langhorne | Pennsylvania |
| United States | Research Site | Laverne | California |
| United States | Research Site | Livingston | New Jersey |
| United States | Research Site | Long Beach | California |
| United States | Research Site | Metairie | Louisiana |
| United States | Research Site | Miami | Florida |
| United States | Research Site | New Orleans | Louisiana |
| United States | Research Site | New Port Richey | Florida |
| United States | Research Site | Overland Park | Kansas |
| United States | Research Site | Pensacola | Florida |
| United States | Research Site | Pittsburgh | Pennsylvania |
| United States | Research Site | Providence | Rhode Island |
| United States | Research Site | Richmond | Virginia |
| United States | Research Site | Royal Oak | Michigan |
| United States | Research Site | San Antonio | Texas |
| United States | Research Site | Santa Rosa | California |
| United States | Research Site | Shreveport | Louisiana |
| United States | Research Site | Spartenburg | South Carolina |
| United States | Research Site | Springfield | Illinois |
| United States | Research Site | St Joseph | Michigan |
| United States | Research Site | Torrington | Connecticut |
| United States | Research Site | Voorhees | New Jersey |
| United States | Research Site | Washington | District of Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United States, Argentina, Belgium, Brazil, Canada, Denmark, France, Germany, Hungary, Israel, Russian Federation, South Africa, Spain, Sweden, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time to disease progression (TTP) | after 580 Progression events accrued | No | |
| Secondary | Objective response rate | after 580 Progression events accrued | No | |
| Secondary | Overall survival | after 580 Progression events accrued | Yes | |
| Secondary | Duration of response | after 580 Progression events accrued | No | |
| Secondary | Clinical Benefit | after 580 Progression events accrued | No | |
| Secondary | Quality of Life | after 580 Progression events accrued | No | |
| Secondary | PK | each visit | No | |
| Secondary | Safety and tolerability. | after 580 Progression events accrued | Yes |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
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