ICI 182780 in Treating Women With Metastatic Breast Cancer
Recruitment status was Active, not recruiting
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using ICI 182780 may fight breast cancer by blocking the activity of estrogen in the tumor cells.
PURPOSE: Phase II trial to study the effectiveness of ICI 182780 in treating patients who have metastatic breast cancer that has not responded to previous hormone therapy.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Trial Of Fulvestrant (Faslodex) In Women With Metastatic Breast Cancer And Failure on Aromatase Inhibitor Therapy|
|Study Start Date:||May 2001|
- Determine the complete and partial objective response rate and duration of response in women with metastatic breast cancer who have failed aromatase inhibitor therapy treated with fulvestrant.
- Determine the time to disease progression and overall survival of women treated with this drug.
- Determine the toxicity of this drug in these women.
OUTLINE: Patients receive fulvestrant intramuscularly on day 1. Courses repeat approximately every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 5 years or until disease progression. After disease progression, patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: Approximately 41-94 patients will be accrued for this study within 10 months.