The PROMISE Study: Prevention of Menopause Symptoms and Breast Cancer Invasion

STUDY BASICS

Are you a postmenopausal woman with a recent diagnosis of ductal carcinoma in situ (DCIS)? Will you be having breast surgery to remove your DCIS? You may be able to participate in a research study to help find out if a study drug called Duavee® causes any changes in your breast tissue. Study participation will involve taking 1 pill a day for 3-5 weeks before your surgery. Compensation is provided.

STUDY PURPOSE

Ductal carcinoma in situ (DCIS) is the growth of abnormal cells in the milk ducts of the breast. Although DCIS often stays in the milk ducts and does not spread into any other tissue, in some cases DCIS can progress to a more aggressive type of breast cancer, called invasive breast cancer, which can spread to other parts of the body. Because of this risk, most women with DCIS have surgery to remove the abnormal cells and many also receive radiation and hormonal treatment.

The purpose of this study is to find out if a hormonal medication called Duavee® causes changes in breast tissue in postmenopausal women with DCIS. Researchers also want to know if Duavee is safe for women with a history of breast cancer who have symptoms of menopause and if Duavee can lessen the symptoms of menopause in women with DCIS. Duavee is FDA-approved to treat and prevent symptoms of menopause such as hot flashes and bone loss in postmenopausal women but has not been approved for women with DCIS.

COULD THIS STUDY BE RIGHT FOR YOU?

• Postmenopausal woman with a new diagnosis of ductal carcinoma in situ (DCIS)
• Participation includes 4 visits over 6-8 weeks

WHAT PARTICIPANTS CAN EXPECT

Participation includes 4 visits over 6-8 weeks. Participants will be randomly assigned (like the flip of a coin) to receive either the study drug Duavee® or a placebo (the placebo looks like the study drug but contains no medication). All participants will be asked to take the study drug or placebo by mouth once per day 3-5 weeks before your surgery. Other study activities include having blood draws, keeping a drug and symptom diary, and completing surveys and questionnaires.