The Evaluation of the Efficacy and Tolerability of FASLODEX (Fulvestrant) and AROMASIN (Exemestane) in Hormone Receptor Positive Postmenopausal Women With Advanced Breast Cancer

Condition(s) targeted: Locally Advanced Breast Cancer; Metastatic Breast Cancer

Intervention: Fulvestrant (Drug); Exemestane (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
AstraZeneca Faslodex Medical Science Director, MD, Study Director, Affiliation: AstraZeneca

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.

Official 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

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Primary outcome: Time to disease progression (TTP)

Secondary outcome:

Objective response rate

Overall survival

Duration of response

Clinical Benefit

Quality of Life

PK

Safety and tolerability.

Minimum age: N/A. Maximum age: N/A. Gender(s): Female.

Criteria:

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)

Research Site, Buenos Aires, City, Argentina

Research Site, Buenos Aires Prov., Argentina

Research Site, Santa Fe prov., Argentina

Research Site, Wilrijk, Belgium

Research Site, Leuven, Belgium

Research Site, Bruxelles, Belgium

Research Site, Ottignies, Belgium

Research Site, Porto Alegre, Brazil

Research Site, Sao Paulo, Brazil

Research Site, Rio de Janeiro, Brazil

Research Site, Goiania, Brazil

Research Site, Florianopolis, Brazil

Research Site, Quebec, Canada

Research Site, Copenhagen, Denmark

Research Site, Alborg, Denmark

Research Site, Hillerod, Denmark

Research Site, Roskilde, Denmark

Research Site, Herning, Denmark

Research Site, Sonderborg, Denmark

Research Site, Bordeaux Cedex, France

Research Site, Lille Cedex, France

Research Site, Vandoeuvre Les Nancy, France

Research Site, Montpellier, France

Paris, France

Research Site, Berlin, Germany

Research Site, Hamburg, Germany

Research Site, Augsburg, Germany

Research Site, Regensburg, Germany

Research Site, Budapest, Hungary

Research Site, Szeged, Hungary

Research Site, Debrecan, Hungary

Research Site, Tel-Aviv, Israel

Research Site, Ramat-Gan, Israel

Research Site, Haifa, Israel

Research Site, Moscow, Russian Federation

Research Site, Saint-Petersburg, Russian Federation

Research Site, Obninsk, Russian Federation

Research Site, Pretoria, South Africa

Research Site, Port Elizabeth, South Africa

Research Site, Morningside, South Africa

Research Site, Tygerberg, South Africa

Research Site, Parktown, South Africa

Research Site, Johannesburg, South Africa

Research Site, Bloemfontein, South Africa

Research Site, Terrassa, Spain

Research Site, Madrid, Spain

Research Site, Barcelona, Spain

Research Site, Valencia, Spain

Research Site, Sevilla, Spain

Research Site, Norrkoping, Sweden

Research Site, Stockholm, Sweden

Research Site, Uppsala, Sweden

Research Site, Gavle, Sweden

Research Site, Halmstad, Sweden

Lund, Sweden

Research Site, Nottingham, United Kingdom

Research Site, Mobile, Alabama, United States

Research Site, Birmingham, Alabama, United States

Research Site, Edmonton, Alberta, Canada

Research Site, Penticton, British Columbia, Canada

Research Site, Vancouver, British Columbia, Canada

Research Site, Santa Rosa, California, United States

Research Site, LaVerne, California, United States

Research Site, Arcadia, California, United States

Research Site, Long Beach, California, United States

Research Site, Fountain Valley, California, United States

Research Site, Campbell, California, United States

Research Site, Panorama, Cape Town, South Africa

Research Site, Wynberg, Capetown, South Africa

Research Site, Torrington, Connecticut, United States

Research Site, Washington, District of Columbia, United States

Research Site, Westridge, Durban, South Africa

Research Site, Pensacola, Florida, United States

Research Site, Jackson, Florida, United States

Research Site, Gainesville, Florida, United States

Research Site, Miami, Florida, United States

Research Site, New Port Richey, Florida, United States

Research Site, Plantation, Florida, United States

Research Site, Naples, Florida, United States

Research Site, Athens, Georgia, United States

Research Site, Honolulu, Hawaii, United States

Research Site, Harvey, Illinois, United States

Research Site, Springfield, Illinois, United States

Research Site, Chicago, Illinois, United States

Research Site, Terre Haute, Indiana, United States

Research Site, Iowa City, Iowa, United States

Research Site, Wilkoppies, Klerksdorp, South Africa

Research Site, Metairie, Louisiana, United States

Research Site, Shreveport, Louisiana, United States

Research Site, Baton Rouge, Louisiana, United States

Research Site, New Orleans, Louisiana, United States

Research Site, Bangor, Maine, United States

Research Site, Winnipeg, Manitoba, Canada

Research Site, Frederick, Maryland, United States

Research Site, Baltimore, Maryland, United States

Research Site, Pittsfield, Massachusetts, United States

Research Site, Kalamazoo, Michigan, United States

Research Site, Royal Oak, Michigan, United States

Research Site, St. Joseph, Michigan, United States

Research Site, Hattiesburg, Mississippi, United States

Research Site, Kansas City, Missouri, United States

Research Site, St. Joseph, Missouri, United States

Research Site, Hooksett, New Hampshire, United States

Research Site, Voorhees, New Jersey, United States

Research Site, Livingston, New Jersey, United States

Research Site, Hackensack, New Jersey, United States

Research Site, Albuquerque, New Mexico, United States

Research Site, St. John's, Newfoundland and Labrador, Canada

Research Site, Charlotte, North Carolina, United States

Research Site, Durham, North Carolina, United States

Research Site, Bismarck, North Dakota, United States

Research Site, Canton, Ohio, United States

Research Site, Oshawa, Ontario, Canada

Research Site, Toronto, Ontario, Canada

Research Site, Windsor, Ontario, Canada

Research Site, Kingston, Ontario, Canada

Research Site, Ottawa, Ontario, Canada

Research Site, London, Ontario, Canada

Research Site, Sudbury, Ontario, Canada

Research Site, Newmarket, Ontario, Canada

Research Site, Hershey, Pennsylvania, United States

Research Site, Kingston, Pennsylvania, United States

Research Site, Pittsburgh, Pennsylvania, United States

Research Site, Langhorne, Pennsylvania, United States

Research Site, LeMoyne, Pennsylvania, United States

Research Site, Lancaster, Pennsylvania, United States

Research Site, Montreal, Quebec, Canada

Research Site, West Montreal, Quebec, Canada

Research Site, Providence, Rhode Island, United States

Research Site, Greenville, South Carolina, United States

Research Site, Spartanburg, South Carolina, United States

Research Site, Columbia, South Carolina, United States

Research Site, Austin, Texas, United States

Research Site, San Antonio, Texas, United States

Research Site, Houston, Texas, United States

Research Site, Dallas, Texas, United States

Research Site, Burlington, Vermont, United States

Research Site, Arlington, Virginia, United States

Research Site, Richmond, Virginia, United States

MEDLINEplus related topics: Breast Cancer

MEDLINEplus related topics: Cancer (General)

MEDLINEplus related topics: Cancer--Living with Cancer

Cancer Guide related topics

Aromasin related topics: Your Treatment with Aromasin

Faslodex Information

Starting date: May 2003
Ending date: July 2008
Last updated: June 11, 2008