Fulvestrant (FASLODEX™) as a Treatment in Postmenopausal Women With Estrogen Receptor Positive Breast Cancer

Last updated: June 11, 2008
Sponsor: AstraZeneca
Overall Status: Completed

Phase

2

Condition

Breast Cancer

Cancer

Treatment

N/A

Clinical Study ID

NCT00093002
9238IL/0065
D6997C00003
  • Female

Study Summary

The purpose of this study is to evaluate fulvestrant in the preliminary stage of breast cancer treatment and assess the relationship between dose, exposure, degree of reduction in tumor markers, and efficacy in postmenopausal women with estrogen receptor positive disease.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Postmenopausal women defined as women who have stopped having menstrual periods

  • Written informed consent to participate in the trial

  • Biopsy confirmation of invasive breast cancer

  • Evidence of hormone sensitivity

  • Willingness to undergo biopsies

Exclusion

Exclusion Criteria:

  • Any previous treatment for breast cancer

  • Unwillingness to stop taking any drug known to affect sex hormonal status or a patientin which it would be inappropriate to stop.

  • Any severe concurrent condition that would preclude surgery or that would jeopardizecompliance with the study, e.g., uncontrolled cardiac disease or uncontrolled diabetesmellitus

  • The presence of more than one primary tumor

  • History of hypersensitivity to castor oil

  • History of known bleeding disorders

Study Design

Total Participants: 179
Study Start date:
June 01, 2004
Estimated Completion Date:
July 31, 2007

Connect with a study center

  • Research Site

    Innsbruck,
    Austria

    Site Not Available

  • Research Site

    Salzburg,
    Austria

    Site Not Available

  • Research Site

    Vienna,
    Austria

    Site Not Available

  • Research Site

    Wien,
    Austria

    Site Not Available

  • Research Site

    Barretos,
    Brazil

    Site Not Available

  • Research Site

    Florianopolis,
    Brazil

    Site Not Available

  • Research Site

    Goiamia,
    Brazil

    Site Not Available

  • Research Site

    Porto Alegre,
    Brazil

    Site Not Available

  • Research Site

    Rio de Janeiro,
    Brazil

    Site Not Available

  • Research Site

    Santo Andre,
    Brazil

    Site Not Available

  • Research Site

    Sao Paulo,
    Brazil

    Site Not Available

  • Research Site

    Berlin,
    Germany

    Site Not Available

  • Research Site

    Hannover,
    Germany

    Site Not Available

  • Research Site

    Magdeburg,
    Germany

    Site Not Available

  • Research Site

    Munchen,
    Germany

    Site Not Available

  • Research Site

    Rostock,
    Germany

    Site Not Available

  • Research Site

    Bangalore,
    India

    Site Not Available

  • Research Site

    Hyderabaad,
    India

    Site Not Available

  • Research Site

    New Delhi,
    India

    Site Not Available

  • Research Site

    Pune,
    India

    Site Not Available

  • Research Site

    Trivandrum,
    India

    Site Not Available

  • Research Site

    Birmingham,
    United Kingdom

    Site Not Available

  • Research Site

    Bournemouth,
    United Kingdom

    Site Not Available

  • Research Site

    Dundee,
    United Kingdom

    Site Not Available

  • Research Site

    Edinburgh,
    United Kingdom

    Site Not Available

  • Research Site

    Little Rock, Arkansas
    United States

    Site Not Available

  • Research Site

    Boston, Massachusetts
    United States

    Site Not Available

  • Research Site

    Winchester, Massachusetts
    United States

    Site Not Available

  • Research Site

    Albuquerque, New Mexico
    United States

    Site Not Available

  • Research Site

    Hershey, Pennsylvania
    United States

    Site Not Available

  • Research Site

    Nashville, Tennessee
    United States

    Site Not Available

  • Research Site

    Laredo, Texas
    United States

    Site Not Available

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