Topical Tamoxifen in DCIS

What is the Purpose of this Study?

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.
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?

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

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