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

Completed · Phase 3

Conditions studied: Locally Advanced Breast Cancer, Metastatic Breast Cancer

In brief

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.

Key facts

Study ID

NCT00065325

Run by

AstraZeneca

People needed

694

Starts

2003-08-01

Expected to finish

2014-09-01

Last updated by the study team

2015-02-24

Who can join

Age: 32 and older, up to 91. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Biopsy confirmation of Breast Cancer
• Breast Cancer has continued to grow after having received treatment with an aromatase inhibitor
• Postmenopausal women defined as a women who has stopped having menstrual periods
• Evidence of hormone sensitivity
• Written informed consent to participate in the trial

You may not qualify if…

• Previous treatment with Faslodex (fulvestrant) or Aromasin (exemestane)
• Any hormonal therapy used to modify the course of an additional medical condition after 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 or compliance with study procedures
• A history of allergies to any active or inactive ingredients of Faslodex or Exemestane (i.e. castor oil or Mannitol)

Where it is running

• Research Site — Arcadia, California, United States
• Research Site — Fountain Valley, California, United States
• Research Site — Laverne, California, United States
• Research Site — Long Beach, California, United States
• Research Site — Santa Rosa, California, United States
• Research Site — Torrington, Connecticut, United States
• Research Site — Washington D.C., District of Columbia, United States
• Research Site — Boca Raton, Florida, United States
• Research Site — Gainesville, Florida, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — New Port Richey, Florida, United States
• Research Site — Pensacola, Florida, United States
• Research Site — Athens, Georgia, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Harvey, Illinois, United States
• Research Site — Springfield, Illinois, United States
• Research Site — Iowa City, Iowa, United States
• Research Site — Overland Park, Kansas, United States
• Research Site — Baton Rouge, Louisiana, United States
• Research Site — Metairie, Louisiana, United States
• Research Site — New Orleans, Louisiana, United States
• Research Site — Shreveport, Louisiana, United States
• Research Site — Bangor, Maine, United States
• Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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