Finding Alternatives for DCIS Treatment

Seema Khan, MD, Northwestern University, Chicago, IL, Joseph Michael Guenther, MD, St. Elizabeth HealthCare, Edgewood, KY, Amy Degnim, MD, Mayo Clinic, Rochester, MN, Melissa Pilewskie, MD, Memorial Sloan Kettering Cancer Center, New York, NY, E. Shelley Hwang, MD, Duke University, Durham, NC, Stephen Grobmyer, MD, Cleveland Clinic, Cleveland, OH

The purpose of this study is to compare the effects of a tamoxifen pill to tamoxifen (4-OHT) gel on breast cells in women with ER+ DCIS. This study will investigate what effects each treatment has on the DCIS and what side effects each treatment may cause. Prior studies show that the topical gel stays mainly in the breast itself with very little getting into the blood. The eventual goal is to provide women with DCIS with an alternative to oral tamoxifen treatment.

What does participation involve?

If you choose to participate, you will visit the closest participating center for a screening visit. You will be asked about your medical history, given a quality of life survey, and provide blood and urine samples.

Participants who are eligible will be randomized into one of two groups:

• Group 1 will receive the tamoxifen (4-OHT) gel and a placebo pill. 

• Group 2 will receive a placebo gel and the tamoxifen pills.

All participants will take a pill and apply gel to their breasts every day for 4 to 10 weeks prior to surgery. Neither you nor your doctor will know which group you are in.

You will keep a study diary to ensure you are taking the study drug as directed. You will receive phone calls to ask how you are doing and to remind you of events in the study calendar. The study team can pair you with a “buddy” from an organization called After Breast Cancer Diagnosis (ABCD) that has experience with breast cancer and is knowledgeable about this trial. She can be in contact with you throughout your participation and provide support.

On the day of your surgery, you will be asked about your medical history, given a quality of life survey, provide blood and urine samples, and return any unused medication. During surgery, in addition to removing the DCIS, the surgeon will take two breast tissue samples.

Your last study visit will be at your regularly scheduled post-op visit in the clinic. The research team will review your progress and give you a quality of life survey. One month after your surgery, the research team will call you and ask you about any side effects you might be experiencing, any medications you are taking, and the date of your last menstrual period.

Participating sites around the U.S – including Chicago, IL, Edgewood, KY, Rochester, MN, New York, NY, Durham, NC, and Cleveland, OH