Breast Cancer Clinical Trial
Official title:
A Pilot Clinical Trial to Evaluate the Biological Activity of Fulvestrant (Faslodex) in Breast Ductal Carcinoma (DCIS)
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using
fulvestrant or tamoxifen may fight breast cancer by blocking the use of estrogen by the
tumor cells. Giving fulvestrant or tamoxifen before surgery may be an effective treatment
for breast cancer.
PURPOSE: This randomized clinical trial is studying how well giving fulvestrant or tamoxifen
works in treating postmenopausal women who are undergoing surgery for ductal carcinoma in
situ of the breast.
OBJECTIVES:
Primary
- 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.
Secondary
- 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
study.
;
Allocation: Randomized, Primary Purpose: Treatment
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