Status:
ACTIVE_NOT_RECRUITING
Comparison of Fulvestrant (FASLODEX™) 250 mg and 500 mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy.
Lead Sponsor:
AstraZeneca
Conditions:
Breast Cancer
Eligibility:
FEMALE
45-130 years
Phase:
PHASE3
Brief Summary
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 oestrogen receptor positive advanced breast canc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 13 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
736 Patients enrolled
Trial Details
Trial ID
NCT00099437
Start Date
February 13 2005
End Date
December 31 2025
Last Update
September 24 2025
Active Locations (106)
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1
Research Site
Casa Grande, Arizona, United States, 85122
2
Research Site
Fountain Valley, California, United States, 92708
3
Research Site
New Britain, Connecticut, United States, 06052
4
Research Site
Crystal River, Florida, United States, 34429