A Pilot Clinical Trial to Evaluate the Biological Activity of Fulvestrant (Faslodex) in Breast Ductal Carcinoma (DCIS)
- Determine, preliminarily, the efficacy of neoadjuvant fulvestrant, in terms of
molecular changes in markers of the estrogen pathway, cell proliferation and apoptosis,
and the epidermal growth factor pathway, in postmenopausal women with newly diagnosed
ductal carcinoma in situ of the breast.
- Determine the toxicity profile of fulvestrant in these patients.
OUTLINE: This is a randomized, placebo-controlled, pilot, multicenter study. Patients are
randomized to 1 of 4 treatment arms.
- Arm I: Patients receive oral placebo once daily on days 1-21.
- Arm II: Patients receive oral tamoxifen once daily on days 1-21.
- Arm III: Patients receive fulvestrant intramuscularly (IM) on day 1.
- Arm IV: Patients receive fulvestrant IM as in arm III but at a higher dose. In all
arms, treatment continues in the absence of disease progression or unacceptable
toxicity. All patients undergo surgical resection of the tumor on approximately day 21.
PROJECTED ACCRUAL: A total of 100 patients (25 per treatment arm) will be accrued for this
Allocation: Randomized, Primary Purpose: Treatment
Molecular markers of the estrogen pathway as measured by immunohistochemistry at 3 weeks
Agustin Garcia, MD
Cedars-Sinai Medical Center
United States: Federal Government
|Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center||Los Angeles, California 90048-1865|