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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 SiteAlabaster, Alabama  
Research SiteAnaheim, California  
Research SiteDanbury, Connecticut  
Research SiteWashington, District of Columbia  
Research SiteBoca Raton, Florida  
Research SiteAlbany, Georgia  
Research SiteArlington Heights, Illinois  
Research SiteAmes, Iowa  
Research SiteHays, Kansas  
Research SiteBaton Rouge, Louisiana  
Research SiteBangor, Maine  
Research SiteBaltimore, Maryland  
Research SiteBattle Kreek, Michigan  
Research SiteHooksett, New Hampshire  
Research SiteBelleville, New Jersey  
Research SiteAlbuquerque, New Mexico  
Research SiteAsheville, North Carolina  
Research SiteAkron, Ohio  
Research SiteAllentown, Pennsylvania  
Research SitePawtucket, Rhode Island  
Research SiteCharleston, South Carolina  
Research SiteAbilene, Texas  
Research SiteBennington, Vermont  
Research SiteAbington, Virginia