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LY353381 in High Risk Women With Hyperplasia
NCT00005879Phase 2
Key facts
- Status
- Completed
- Start
- Aug 2000
- Primary completion
- Jul 2008
- Countries
- 1
- Sponsor
- University of Kansas Medical Center
- Modality
- Small Molecules
- Drugs
- arzoxifene
- Conditions
- breast cancer
01
Overview
Phase 2, randomised, double-blind trial in breast cancer comparing Arzoxifene with Placebo (2 arms). Primary endpoints: Change in Masood Score at 6 months and Number of Participants With Improvement From Baseline in Cytomorphologic Abnormality at 6 months. Started Aug 2000; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Arzoxifene
Oral LY353381 hydrochloride once daily for 6 months, then continued for another 6 months.
Placebo
Oral placebo once daily for 6 months, then oral LY353381 hydrochloride for an additional 6 months.
03
Who it enrols
Women 18 and older with FNA evidence of hyperplasia (with or without atypia but with high risk factors), no active cancer, and adequate organ function.
04
Endpoints
Primary
Change in Masood Score
Number of Participants With Improvement From Baseline in Cytomorphologic Abnormality
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