Breast Cancer Clinical Trial
Official title:
A Phase IB Randomized Study of an Antiestrogen in Women With Newly Diagnosed Breast Cancer
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using
tamoxifen or LY353381 may fight breast cancer by blocking the use of estrogen.
PURPOSE: This randomized phase I trial is studying how well tamoxifen works on the
biomarkers of the tumor tissue, compared with LY353381, in treating women with newly
diagnosed breast cancer.
OBJECTIVES:
- Determine whether LY353381 hydrochloride or tamoxifen administered in the interval
between biopsy and re-excision alters the expression of tissue biomarkers relative to
placebo controls in postmenopausal women with newly diagnosed breast cancer.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study.
- Phase I: Patients are randomized to receive either oral LY353381 hydrochloride or oral
placebo daily.
Upon completion of phase I, all treatment centers begin phase II of the study.
- Phase II: Patients are randomized to receive either oral tamoxifen or oral placebo
daily.
Treatment in both phases continues for 2-6 weeks (until scheduled lumpectomy or mastectomy)
in the absence of disease progression or unacceptable toxicity.
Patients are followed at 1 and 2 weeks after surgery.
PROJECTED ACCRUAL: A minimum of 120 patients (60 per treatment phase) will be accrued for
this study within 18 months.
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