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A Randomized, Double Blind, Multicenter Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEX™) vs. Exemestane (AROMASIN™) in Postmenopausal Women With Hormone Receptor Positive Advanced Breast Cancer With Disease Progression After Prior Non-Steroidal Aromatase Inhibitor (AI) Therapy


Phase 3
N/A
N/A
Open (Enrolling)
Female
Locally Advanced Breast Cancer, Metastatic Breast Cancer

Thank you

Trial Information

A Randomized, Double Blind, Multicenter Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEX™) vs. Exemestane (AROMASIN™) in Postmenopausal Women With Hormone Receptor Positive Advanced Breast Cancer With Disease Progression After Prior Non-Steroidal Aromatase Inhibitor (AI) Therapy


Inclusion Criteria:



- 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

Exclusion Criteria:

- 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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Time to disease progression (TTP)

Outcome Time Frame:

after 580 Progression events accrued

Safety Issue:

No

Principal Investigator

AstraZeneca Faslodex Medical Science Director, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

United States: Food and Drug Administration

Study ID:

9238IL/0048

NCT ID:

NCT00065325

Start Date:

August 2003

Completion Date:

December 2012

Related Keywords:

  • Locally Advanced Breast Cancer
  • Metastatic Breast Cancer
  • Locally advanced breast cancer
  • metastatic breast cancer
  • Breast Cancer
  • Cancer of Breast
  • Cancer of the Breast
  • Breast Neoplasms

Name

Location

Research Site Alabaster, Alabama  
Research Site Anaheim, California  
Research Site Danbury, Connecticut  
Research Site Washington, District of Columbia  
Research Site Boca Raton, Florida  
Research Site Albany, Georgia  
Research Site Arlington Heights, Illinois  
Research Site Ames, Iowa  
Research Site Hays, Kansas  
Research Site Baton Rouge, Louisiana  
Research Site Bangor, Maine  
Research Site Baltimore, Maryland  
Research Site Battle Kreek, Michigan  
Research Site Hooksett, New Hampshire  
Research Site Belleville, New Jersey  
Research Site Albuquerque, New Mexico  
Research Site Asheville, North Carolina  
Research Site Akron, Ohio  
Research Site Allentown, Pennsylvania  
Research Site Pawtucket, Rhode Island  
Research Site Charleston, South Carolina  
Research Site Abilene, Texas  
Research Site Bennington, Vermont  
Research Site Abington, Virginia