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Topical Tamoxifen in DCIS - Clinical Trial

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 the Study?

Women who
- Are diagnosed with ER positive DCIS of the breast
- Are at increased risk for future invasive breast cancer

Age Group
Adults

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
Surgical Oncologist
Protocol Number
IRB:PRO00081034
NCT:NCT02993159
Phase
Phase II
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698