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.

  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:b152583dbbbb2ec2692fe4c2177b7001' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>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.</p>\n', created = 1283576048, expire = 1283662448, headers = '', serialized = 0 WHERE cid = '1:b152583dbbbb2ec2692fe4c2177b7001' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:030cdb3d891743016ea7db276256a751' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>A Randomised, Double-Blind, Parallel-Group, Multicentre, Phase III Study Comparing the Efficacy and Tolerability of Fulvestrant (FASLODEX&#8482;) 500 mg With Fulvestrant (FASLODEX&#8482;) 250 mg in Postmenopausal Women With Oestrogen Receptor Positive Adv</p>\n', created = 1283576048, expire = 1283662448, headers = '', serialized = 0 WHERE cid = '1:030cdb3d891743016ea7db276256a751' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:cc7819055cde3194bb3b136bad5cf58d' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>&nbsp;</p>\n', created = 1283576048, expire = 1283662448, headers = '', serialized = 0 WHERE cid = '1:cc7819055cde3194bb3b136bad5cf58d' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:4f211f517f3e3cf655099cbbc400d2e1' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Inclusion Criteria:\n<ul>\n<li>Breast Cancer has continued to grow after having received treatment with an anti-estrogen hormonal treatment such as tamoxifen or an aromatase inhibitor</li>\n<li>Requiring hormonal treatment</li>\n<li>Postmenopausal women defined as a woman who has stopped having menstrual periods</li>\n<li>Evidence of positive estrogen receptor hormone sensitivity</li>\n<li>Written informed consent to participate in the trial</li>\n</ul>\n</p><p> Exclusion Criteria:\n<ul>\n<li>Treatment with an investigational or non-approved drug within one month</li>\n<li>An existing serious disease, illness, or condition that will prevent participation or compliance with study procedures</li>\n<li>A history of allergies to any active or inactive ingredients of Faslodex (i.e. castor oil)</li>\n<li>Treatment with more than one regimen of chemotherapy for advanced breast cancer</li>\n<li>Treatment with more than one regimen of hormonal treatment for advanced breast cancer</li>\n</ul>\n</p>', created = 1283576048, expire = 1283662448, headers = '', serialized = 0 WHERE cid = '1:4f211f517f3e3cf655099cbbc400d2e1' in /persistent/html/includes/cache.inc on line 109.
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