Are you planning to have breast surgery?

Many women hesitate to take breast cancer prevention medication for fear of side effects. We are trying to reduce the side effects of these medications by using a medicated gel, applied to the breast skin. Currently, two of our studies are looking at the use of medicated gel as possible breast cancer prevention methods.  Applying medicated gel to the breast skin in the weeks leading up to your breast surgery will not treat your current condition and will not interfere with your surgery, but will help us find out if this may be a safe and effective method for breast cancer prevention.

 

Testing an Active Form of Tamoxifen Delivered Through the Breast Skin to Control Ductal Carcinoma in Situ (DCIS) of the Breast

Principal Investigator: Seema Khan, M.D.
Northwestern University

This study tests whether the medicated gel containing an active form of tamoxifen applied directly to the breasts will decrease the growth rate of DCIS cells as effectively as a tamoxifen pill taken by mouth. Unlike the pill, the gel will be concentrated in the breasts and therefore very little may circulate throughout the blood stream and body. As a result, we expect that the side effects may be greatly decreased. If you participate in this study, you will help us learn if this new method of using tamoxifen is likely to be effective. If it is as effective as the pill, more women may accept gel medication for DCIS and for breast cancer prevention.

 

The study has two groups:

Group 1: Apply medicated gel to each breast once every day, and take a placebo capsule by mouth once every day at the same time the gel is applied for 4-10 weeks prior to surgery

Group 2: Apply placebo gel to each breast once every day, and take a medicated capsule by mouth once every day at the same time the gel is applied for 4-10 weeks prior to surgery

 

We will enroll up to 100 women in this study.

 

You may be eligible if you:

  • Are a woman recently diagnosed with estrogen receptor positive DCIS and have not had surgery yet

  • Are not a smoker

  • Are 18 years or older

  • Are not currently pregnant or breastfeeding

 

You may be compensated up to $300 to help offset time and transportation costs associated with your participation in this study.

If you would like more information, or are interested in participating, please click your preferred location below to send an email to the study team. If you would like a response, please be sure to include a phone number where we can reach you in your message.

NORTHWESTERN UNIVERSITY - Chicago, Illinois

CLEVELAND CLINIC - Cleveland, Ohio

DUKE UNIVERSITY - Durham, North Carolina

SAINT ELIZABETH HEALTHCARE - Edgewood, Kentucky

MEMORIAL SLOAN KETTERING CANCER CENTER - New York City, New York

MAYO CLINIC - Rochester, Minnesota

UNIVERSITY OF KANSAS CANCER CENTER - Kansas City, Kansas

 

Endoxifen Gel vs. Placebo Gel in Women Undergoing Breast Surgery

Principal Investigator: Seema Khan, M.D.
Northwestern University

This is a study to test the safety of a medicated gel containing endoxifen (an active form of tamoxifen) applied to the breast skin at different doses. By developing methods to treat the breast with a gel applied to the skin, we hope to greatly reduce the drug dose to the rest of the body, and therefore decrease side-effects of drugs taken for prevention of breast cancer.  In this study, we will test if endoxifen gel can be applied to the breast skin without causing skin irritation, compared to a placebo gel (that contains no endoxifen). The endoxifen gel will be tested at two doses in this study (10 mg endoxifen daily or 20 mg daily). We will also compare the amount of the drug that reaches the breast at each of these doses. We are enrolling women who are planning unilateral or bilateral mastectomy for any reason,  and are willing to apply the study gel to both breasts daily for three to four weeks leading up to the day of their surgery.

 

The study has three groups:

 

 

 

We will enroll up to 38 women in this study.

 You may be eligible if you:

  • Are a woman planning surgery to remove one or both breasts for stage 0-III breast cancer treatment or for breast cancer prevention

  • Are 18 years or older

  • Are not currently pregnant or breastfeeding

 

You may be reimbursed up to $300 to help offset time and transportation costs associated with your participation in this study.

 

Study Locations:

Chicago, IL - Northwestern University

Los Angeles, CA - Cedars-Sinai Medical Center

New York, New York - Memorial Sloan-Kettering Cancer Center

If you think you may be eligible, click below to fill out a contact form and we'll make sure you get matched with the right study team.

38

24 women have joined this study so far!

Content on NUcancerprevention.org is a courtesy from the Northwestern Cancer Prevention Consortium at Northwestern University. While we strive to maintain the most current and up to date information possible, NCPC does not guarantee accuracy, completeness, or relevance of the information supplied. The thoughts, views, and information found here do not necessarily reflect the views of Northwestern University or Northwestern Medicine. 

©2023 by Northwestern Cancer Prevention Consortium.