A Trial Comparing the Efficacy and Tolerability of Faslodex With Nolvadex in Postmenopausal Women With Advanced Breast Cancer

Completed · Phase 3

Conditions studied: Breast Cancer, Metastasis

In brief

The purpose of this study is to compare the efficacy of Faslodex (fulvestrant) to Nolvadex (tamoxifen) as first-line treatment for 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.

Key facts

Study ID

NCT00241449

Run by

AstraZeneca

People needed

51

Starts

1998-11-01

Expected to finish

2012-01-01

Last updated by the study team

2012-06-06

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Biopsy confirmation of breast cancer. Evidence of breast cancer that is not considered amenable to curative treatment.
• Postmenopausal women. Written informed consent to participate in the study.

You may not qualify if…

• Previous treatment with hormonal therapy unless that therapy was tamoxifen for adjuvant breast cancer. The use of tamoxifen must have ceased at least one year before this study.
• Previous treatment with Faslodex. Any existing serious disease, illness, or condition that will prevent participation or compliance with the study procedures.
• Treatment with an investigational or non-approved drug within one month of then start of the study.

Where it is running

• Research Site — Fountain Valley, California, United States
• Research Site — La Jolla, California, United States
• Research Site — Orange, California, United States
• Research Site — Washington D.C., District of Columbia, United States
• Research Site — Venice, Florida, United States
• Research Site — Decatur, Georgia, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Mason City, Iowa, United States
• Research Site — Shreveport, Louisiana, United States
• Research Site — Gloucester, Massachusetts, United States
• Research Site — Detroit, Michigan, United States
• Research Site — Voorhees Township, New Jersey, United States
• Research Site — Columbus, Ohio, United States
• Research Site — Meadowbrook, Pennsylvania, United States
• Research Site — Providence, Rhode Island, United States
• Research Site — Austin, Texas, United States
• Research Site — Galveston, Texas, United States
• Research Site — Houston, Texas, United States
• Research Site — San Antonio, Texas, United States
• Research Site — Temple, Texas, United States
• Research Site — Richmond, Virginia, United States
• Research Site — Lacey, Washington, United States
• Research Site — Seattle, Washington, United States
• Research Site — Buenos Aires, Argentina
• Research Site — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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