Topical Tamoxifen in DCIS (Breast Cancer)

What is the Purpose of this Study?

If you choose to join this study, you will:
- Be randomized (like the flip of a coin) to one of the two treatment groups:
-- Group 1 will get a topical Tamoxifen gel to use once a day for 4-10 weeks prior to surgery plus a placebo (inactive medicine) capsule taken every day
-- Group 2 will get the placebo (inactive medicine) gel to use once a day for 4-10 weeks prior to surgery plus a Tamoxifen capsule to take every day
What is the Condition Being Studied?
Ductal Carcinoma In Situ (DCIS)

Who Can Participate in this Study?

Women who

- Are diagnosed with ER positive DCIS of the breast

- Are at increased risk for future invasive breast cancer

Age Group
Adults
Participating Institutions

What is Involved?

We are doing this study to test the use of a topical Tamoxifen gel prior to surgery to see if it will decrease the growth rate of DCIS cells.

Study Details

Full Title
Phase IIB pre-surgical trial of oral tamoxifen versus transdermal 4-hydroxytamoxifen in women with DCIS of the breast
Principal Investigator
Eun-Sil Hwang
Mary and Deryl Hart Distinguished Professor of Surgery, in the School of Medicine

Contacts
Protocol Number
IRB:
PRO00081034

NCT:
NCT02993159
ClinicalTrials.gov
View on ClinicalTrials.gov