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

Completed · Phase 2

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT00093002

Run by

AstraZeneca

People needed

179

Starts

2004-06-01

Expected to finish

2007-07-01

Last updated by the study team

2008-06-12

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• Any previous treatment for breast cancer
• Unwillingness to stop taking any drug known to affect sex hormonal status or a patient in which it would be inappropriate to stop.
• Any severe concurrent condition that would preclude surgery or that would jeopardize compliance with the study, e.g., uncontrolled cardiac disease or uncontrolled diabetes mellitus
• The presence of more than one primary tumor
• History of hypersensitivity to castor oil
• History of known bleeding disorders

Where it is running

• Research Site — Little Rock, Arkansas, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — Winchester, Massachusetts, United States
• Research Site — Albuquerque, New Mexico, United States
• Research Site — Hershey, Pennsylvania, United States
• Research Site — Nashville, Tennessee, United States
• Research Site — Laredo, Texas, United States
• Research Site — Innsbruck, Austria
• Research Site — Salzburg, Austria
• Research Site — Vienna, Austria
• Research Site — Barretos, Brazil
• Research Site — Florianópolis, Brazil
• Research Site — Goiamia, Brazil
• Research Site — Porto Alegre, Brazil
• Research Site — Rio de Janeiro, Brazil
• Research Site — Santo André, Brazil
• Research Site — São Paulo, Brazil
• Research Site — Berlin, Germany
• Research Site — Hanover, Germany
• Research Site — Magdeburg, Germany
• Research Site — München, Germany
• Research Site — Rostock, Germany
• Research Site — Bangalore, India
• Research Site — Hyderabaad, India
• Research Site — New Delhi, India

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.