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

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Trial phase: 
Phase III
Recruitment status: 
Active, not recruiting

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 estrogen receptor positive advanced breast cancer who have failed on a previous endocrine treatment.

Background information
Trial ID: 
NCT00099437
Other unique IDs: 
D6997C00002
CONFIRM
Official title: 

A Randomised, Double-Blind, Parallel-Group, Multicentre, Phase III Study Comparing the Efficacy and Tolerability of Fulvestrant (FASLODEX™) 500 mg With Fulvestrant (FASLODEX™) 250 mg in Postmenopausal Women With Oestrogen Receptor Positive Adv

Detailed description: 

 

Number to be enrolled: 
736 patients
Acronym: 
CONFIRM
Clinical information
Age groups: 
Adult
Senior
Child
Gender: 
Female
Eligibility criteria: 

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study design: 
Treatment
Randomized
Parallel Assignment
Efficacy Study
Dose Comparison
Interventions: 
Fulvestrant
Study arms: 
Experimental: Fulvestrant 500 mg
Experimental: Fulvestrant 250 mg
Conditions treated: 
Breast Cancer
Funding
Funding types: 
INDUSTRY
Sponsor: 
AstraZeneca
Dates
Date the data was first received: 
Mon, 2004-12-13
Trial start date: 
Mon, 2005-08-01
Trial completion date: 
Wed, 2009-07-01
Trial last updated: 
Wed, 2009-05-20