Trials / Completed
CompletedNCT00005886
Tamoxifen Compared With LY353381 in Treating Women With Newly Diagnosed Breast Cancer
A Phase IB Randomized Study of an Antiestrogen in Women With Newly Diagnosed Breast Cancer
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- University of Kansas Medical Center · Academic / Other
- Sex
- Female
- Age
- 18 Years – 120 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | arzoxifene hydrochloride | |
| DRUG | tamoxifen citrate |
Timeline
- Start date
- 2000-07-01
- Primary completion
- 2002-08-01
- Completion
- 2002-08-01
- First posted
- 2003-08-29
- Last updated
- 2017-01-13
Locations
9 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00005886. Inclusion in this directory is not an endorsement.