drugset / Trial / NCT01614210

Preoperative Window of Endocrine Therapy Provides Information to Increase Compliance

NCT01614210 ↗

Phase 2 Completed 52 enrolled University of Utah
NaSingle-groupOpen-labelTreatment

Summary

The purpose of the study is to see if tumors respond to endocrine therapy by taking a total of 21 doses of Tamoxifen before and after surgery. Tamoxifen is currently approved by the FDA (Food and Drug Administration) for use in the treatment of hormone positive breast cancer.

Timeline

Start
2012-08
Primary completion
2016-11
Completion
2016-11

Outcome

Met primary endpoint

registry MEAN Tamoxifen Pre and Post Breast Surgery: -40 (-63 to -29) percentage change in Ki67 NCT01614210 ↗

registry analysis (other test); Tamoxifen Pre and Post Breast Surgery; p = 0.0001; t-test, 1 sided NCT01614210 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Tamoxifen Small molecule 20 mg Oral