Comparison of Fulvestrant (FASLODEX™) 250 mg and 500 mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy.

Running, not enrolling · Phase 3

Conditions studied: Breast Cancer

In brief

The purpose of this study is to evaluate the efficacy of a new dose of 500 mg Fulvestrant with the standard dose of 250 mg in postmenopausal women with oestrogen receptor positive advanced breast cancer who have failed on a previous endocrine treatment.

Key facts

Study ID: NCT00099437
Run by: AstraZeneca
People needed: 736
Starts: 2005-02-13
Expected to finish: 2026-12-31
Last updated by the study team: 2026-06-11

Who can join

Age: 45 and older, up to 130. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

Breast Cancer has continued to grow after having received treatment with an anti-estrogen hormonal treatment such as tamoxifen or an aromatase inhibitor
Requiring hormonal treatment
Postmenopausal women defined as a woman who has stopped having menstrual periods
Evidence of positive estrogen receptor hormone sensitivity
Written informed consent to participate in the trial

You may not qualify if…

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 (i.e. castor oil)
Treatment with more than one regimen of chemotherapy for advanced breast cancer
Treatment with more than one regimen of hormonal treatment for advanced breast cancer

Where it is running

Research Site — Fountain Valley, California, United States
Research Site — New Britain, Connecticut, United States
Research Site — Crystal River, Florida, United States
Research Site — Fort Lauderdale, Florida, United States
Research Site — Urbana, Illinois, United States
Research Site — Rosedale, Maryland, United States
Research Site — Detroit, Michigan, United States
Research Site — Kansas City, Missouri, United States
Research Site — St Louis, Missouri, United States
Research Site — Voorhees Township, New Jersey, United States
Research Site — Greenville, North Carolina, United States
Research Site — Pasadena, Texas, United States
Research Site — West Bend, Wisconsin, United States
Research Site — Brasschaat, Belgium
Research Site — Brussels, Belgium
Research Site — Brussels, Belgium
Research Site — Edegem, Belgium
Research Site — Ghent, Belgium
Research Site — Hasselt, Belgium
Research Site — Liège, Belgium
Research Site — Turnhout, Belgium
Research Site — Barretos, Brazil
Research Site — Londrina, Brazil
Research Site — Porto Alegre, Brazil
Research Site — Casa Grande, Arizona, United States

Full record on ClinicalTrials.gov

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