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Active Not Recruiting
NCT00099437
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.
Conditions: Breast Cancer
Sex: Female
Ages: 45 Years – 130 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 736
Sponsor: AstraZeneca
Location: Research Site Casa Grande Arizona
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 cancer who have failed on a previous endocrine treatment.
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
Source: ClinicalTrials.gov (NCT00099437). StuddyBuddy aggregates publicly available trial information.