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

Last updated: February 23, 2015
Sponsor: AstraZeneca
Overall Status: Completed

Phase

3

Condition

Metastatic Cancer

Breast Cancer

Treatment

N/A

Clinical Study ID

NCT00065325
9238IL/0048
EFECT
D6997C00048
  • Ages 32-91
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Biopsy confirmation of Breast Cancer

  • Breast Cancer has continued to grow after having received treatment with an aromataseinhibitor

  • 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

Exclusion Criteria:

  • Previous treatment with Faslodex (fulvestrant) or Aromasin (exemestane)

  • Any hormonal therapy used to modify the course of an additional medical conditionafter 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 orcompliance with study procedures

  • A history of allergies to any active or inactive ingredients of Faslodex or Exemestane (i.e. castor oil or Mannitol)

Study Design

Total Participants: 694
Study Start date:
August 01, 2003
Estimated Completion Date:
September 30, 2014

Connect with a study center

  • Research Site

    Ciudad de Buenos Aires, Buenos Aires
    Argentina

    Site Not Available

  • Research Site

    Mar Del Plata, Buenos Aires
    Argentina

    Site Not Available

  • Research Site

    Rosario, Santa Fe
    Argentina

    Site Not Available

  • Research Site

    Buenos Aires,
    Argentina

    Site Not Available

  • Research Site

    Buenos Aires Prov.,
    Argentina

    Site Not Available

  • Research Site

    Buenos Aires, City,
    Argentina

    Site Not Available

  • Research Site

    Santa Fe prov.,
    Argentina

    Site Not Available

  • Research Site

    Brussels,
    Belgium

    Site Not Available

  • Research Site

    Bruxelles,
    Belgium

    Site Not Available

  • Research Site

    Leuven,
    Belgium

    Site Not Available

  • Research Site

    Ottignies,
    Belgium

    Site Not Available

  • Research Site

    Wilrijk,
    Belgium

    Site Not Available

  • Research Site

    Goiania, GO
    Brazil

    Site Not Available

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    Rio de Janeiro, RJ
    Brazil

    Site Not Available

  • Research Site

    Porto Alegre, RS
    Brazil

    Site Not Available

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    Sao Paulo, SP
    Brazil

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    Florianopolis,
    Brazil

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    Edmonton, Alberta
    Canada

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    Penticton, British Columbia
    Canada

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    Vancouver, British Columbia
    Canada

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    Winnipeg, Manitoba
    Canada

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    St. John's, Newfoundland and Labrador
    Canada

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    Kingston, Ontario
    Canada

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    London, Ontario
    Canada

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    Newmarket, Ontario
    Canada

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    Oshawa, Ontario
    Canada

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    Ottawa, Ontario
    Canada

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    Sault Ste. Marie, Ontario
    Canada

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    Sudbury, Ontario
    Canada

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    Toronto, Ontario
    Canada

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    Windsor, Ontario
    Canada

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    Montreal, Quebec
    Canada

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    West Montreal, Quebec
    Canada

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    Quebec,
    Canada

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    Alborg,
    Denmark

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    Copenhagen,
    Denmark

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    Herning,
    Denmark

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    Hillerod,
    Denmark

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    Kobenhavn O,
    Denmark

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    Roskilde,
    Denmark

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    Sonderborg,
    Denmark

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    Bordeaux Cedex,
    France

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    Lille Cedex,
    France

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    Montpellier,
    France

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    Montpellier Cedex 5,
    France

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  • empty

    Paris,
    France

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    Vandoeuvre Les Nancy,
    France

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    Augsburg,
    Germany

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    Berlin,
    Germany

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    Hamburg,
    Germany

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    Regensburg,
    Germany

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    Budapest,
    Hungary

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    Debrecan,
    Hungary

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    Debrecen,
    Hungary

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    Szeged,
    Hungary

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    Haifa,
    Israel

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    Ramat-Gan,
    Israel

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    Tel-aviv,
    Israel

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    Obninsk, Kaluga Region
    Russian Federation

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    Moscow,
    Russian Federation

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    Saint-Petersburg,
    Russian Federation

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    St-petersburg,
    Russian Federation

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    Panorama, Cape Town
    South Africa

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    Wynberg, Capetown
    South Africa

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    Westridge, Durban
    South Africa

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    Wilkoppies, Klerksdorp
    South Africa

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    Klerksdorp, North West Province
    South Africa

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    Bloemfontein,
    South Africa

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    Cape Town,
    South Africa

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    Johannesburg,
    South Africa

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    Morningside,
    South Africa

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    Parktown,
    South Africa

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    Port Elizabeth,
    South Africa

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    Pretoria,
    South Africa

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    Tygerberg,
    South Africa

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    Sevilla, Andalucia
    Spain

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    Barcelona, Cataluna
    Spain

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    Hospitalet Dellobregat(barcelo, Cataluna
    Spain

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    Terrassa(barcelona), Cataluna
    Spain

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    Valencia, Comunidad Valenciana
    Spain

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    Madrid, Comunidad de Madrid
    Spain

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    Terrassa,
    Spain

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    Gavle,
    Sweden

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    Halmstad,
    Sweden

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    Lund,
    Sweden

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    Norrkoping,
    Sweden

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    Stockholm,
    Sweden

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    Uppsala,
    Sweden

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    Nottingham,
    United Kingdom

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    Birmingham, Alabama
    United States

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    Mobile, Alabama
    United States

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    Arcadia, California
    United States

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    Campbell, California
    United States

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    Fountain Valley, California
    United States

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    Laverne, California
    United States

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    Long Beach, California
    United States

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    Santa Rosa, California
    United States

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    Torrington, Connecticut
    United States

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    Washington, District of Columbia
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    Boca Raton, Florida
    United States

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    Gainesville, Florida
    United States

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    Jackson, Florida
    United States

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    Jacksonville, Florida
    United States

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    Miami, Florida
    United States

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    Naples, Florida
    United States

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    New Port Richey, Florida
    United States

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    Pensacola, Florida
    United States

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    Plantation, Florida
    United States

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    Athens, Georgia
    United States

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    Honolulu, Hawaii
    United States

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    Chicago, Illinois
    United States

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    Harvey, Illinois
    United States

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    Springfield, Illinois
    United States

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    Terre Haute, Indiana
    United States

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    Iowa City, Iowa
    United States

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    Overland Park, Kansas
    United States

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  • Research Site

    Baton Rouge, Louisiana
    United States

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    Metairie, Louisiana
    United States

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  • Research Site

    New Orleans, Louisiana
    United States

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  • Research Site

    Shreveport, Louisiana
    United States

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  • Research Site

    Bangor, Maine
    United States

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  • Research Site

    Baltimore, Maryland
    United States

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    Frederick, Maryland
    United States

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    Pittsfield, Massachusetts
    United States

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  • Research Site

    Kalamazoo, Michigan
    United States

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    Royal Oak, Michigan
    United States

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    St Joseph, Michigan
    United States

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    Hattiesburg, Mississippi
    United States

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    Kansas City, Missouri
    United States

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    St. Joseph, Missouri
    United States

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  • Research Site

    Hooksett, New Hampshire
    United States

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    Hackensack, New Jersey
    United States

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  • Research Site

    Livingston, New Jersey
    United States

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    Voorhees, New Jersey
    United States

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  • Research Site

    Albuquerque, New Mexico
    United States

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  • Research Site

    Charlotte, North Carolina
    United States

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  • Research Site

    Durham, North Carolina
    United States

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  • Research Site

    Bismarck, North Dakota
    United States

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  • Research Site

    Canton, Ohio
    United States

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  • Research Site

    Hershey, Pennsylvania
    United States

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  • Research Site

    Lancaster, Pennsylvania
    United States

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  • Research Site

    Langhorne, Pennsylvania
    United States

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    LeMoyne, Pennsylvania
    United States

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    Pittsburgh, Pennsylvania
    United States

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    Providence, Rhode Island
    United States

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  • Research Site

    Columbia, South Carolina
    United States

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    Greenville, South Carolina
    United States

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    Spartanburg, South Carolina
    United States

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    Spartenburg, South Carolina
    United States

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  • Research Site

    Austin, Texas
    United States

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    Dallas, Texas
    United States

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    Houston, Texas
    United States

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  • Research Site

    San Antonio, Texas
    United States

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  • Research Site

    Burlington, Vermont
    United States

    Site Not Available

  • Research Site

    Arlington, Virginia
    United States

    Site Not Available

  • Research Site

    Richmond, Virginia
    United States

    Site Not Available

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