drugset / Trial / NCT00952731

4-Hydroxytamoxifen or Tamoxifen Citrate in Treating Women With Newly Diagnosed Ductal Breast Carcinoma in Situ

NCT00952731

RandomizedParallel-groupDouble-blindTreatment

Summary

This randomized phase II trial is studying 4-hydroxytamoxifen to see how well it works compared with tamoxifen citrate in treating women with newly diagnosed ductal breast carcinoma in situ. Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the use of estrogen by the tumor cells. It is not yet known whether topical tamoxifen causes less damage to normal tissue than systemic tamoxifen in treating patients with ductal carcinoma in situ.

Timeline

Start
2009-12
Primary completion
2011-09
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Afimoxifene Other / unclassified 2 mg Topical
Comparator Tamoxifen Small molecule 20 mg Oral