CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 199 enrolled
Drug / intervention
arzoxifene +1 moredrug
Likely dose
Arzoxifene, one tablet dailyAI-extracted
Key inclusion· 7
  • ✓Fine needle aspiration evidence of hyperplasia with atypia, OR hyperplasia without atypia plus one of: 10-year modified Gail risk ≥4%, BRCAPRO risk ≥25%, known BRCA1/BRCA2 mutation, or history of contralateral DCIS or invasive breast cancer
  • ✓FNA obtained during days 1-14 of menstrual cycle for premenopausal women
  • ✓Mammogram ACR class I-III with stepwedge within past 6 months
  • ✓Pelvic ultrasound within past 6 months (if uterus/ovaries intact) showing endometrial thickness ≤13 mm (premenopausal) or ≤8 mm (postmenopausal); no unresolved non-physiologic ovarian cysts
Key exclusion· 5
  • ✕Active detectable cancer or other active cancer
  • ✕History of deep venous thrombosis not related to trauma or pregnancy, or history of stroke
  • ✕Severe coronary artery disease
  • ✕Retinal vein thrombosis, or deficiencies in protein C, protein S, or antithrombin III, or activated protein C resistance, or factor V Leiden mutation carrier

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00005879
NCT00005879Phase 2Completed
CompareCT.gov

A Phase II Clinical Trial of a Selective Estrogen Receptor Modulator (LY353381*HCl) in High Risk Women With Fine Needle Aspiration Cytologic Evidence of Hyperplasia

University of Kansas Medical Center·interventional·Posted Jan 27, 2003·Updated May 30, 2017

In Brief

A Phase 2 clinical trial evaluating arzoxifene and Placebo for Breast Cancer. Completed, enrolled 199 participants across 2 sites.

Detailed Summary

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of LY353381 may be an effective way to prevent the development of breast cancer in women who have hyperplasia. PURPOSE: Randomized phase II trial to study the effectiveness of LY353381 in preventing breast cancer in women who have hyperplasia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartAug 1, 2000
Primary CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 7.9 yearsPosted 23.4 years ago

Interventions

arzoxifenedrug

one tablet daily

Placebodrug

matched tablet dialy