What is the PROMISE Study?

The PROMISE study focuses on the prevention of menopause symptoms and breast cancer invasion.

What do we hope to learn?

There is preliminary evidence to suggest that a medication, Duavee®, reduces the risk of breast cancer. However, we are not certain if this is true in women.

We hope to answer whether this medication could prevent Ductal Carcinoma in Situ (DCIS) from developing into an invasive form of breast cancer through its action on the milk ducts and surrounding tissue (stroma) in the breast.

We also want to see if this medication is safe for women with a history of breast cancer who have menopausal symptoms and if it can lessen the symptoms of menopause in women with DCIS.

What is Duavee?

The onset of menopause brings along a variety of symptoms that can reduce the quality of life for many women.

Duavee® is a combination of conjugated estrogens and bazedoxifene (CE/BZA), also known as a Tissue Selective Estrogen Complex (TSEC). TSECs are currently approved by the FDA to treat and prevent symptoms of menopause including hot flashes and bone loss.

This new therapy is different from older hormone replacement therapies (HRT) because it targets these symptoms without increasing the risk of breast cancer, endometrial (uterus) cancer, ovarian cancer, stroke, or blood clots.

What is DCIS?

DCIS is the presence of abnormal cells inside of a milk duct in the breast. DCIS is not life-threatening, but having DCIS can increase the risk of developing an invasive breast cancer later on in life. The reason to treat DCIS is to prevent it from spreading.

What is the usual treatment for DCIS?

Because DCIS has a few different growth patterns, there can be different recommendations for treatment. Currently, DCIS is usually removed surgically and, in most cases, this is followed by radiation and possibly, more medicine.

Is it dangerous to delay surgery for DCIS?

Doctors in this field agree that patients can take their time to consider their options and plan around their schedules. Women participating in clinical trials that test medical treatment prior to surgery have waited up to six months to have surgery. In fact, clinical trials have started in the United States and Europe to study the idea that women with low-risk DCIS can safely avoid having surgery.

Why consider a DCIS clinical trial?

Women who want to have less treatment for DCIS are encouraged to consider a clinical trial. We appreciate you considering a trial and your care will not be affected by whether you choose to participate. Participation may not benefit you, but it will help increase our knowledge about how to give women with DCIS the treatment they need.

Who can participate in the study?

Are you a postmenopausal woman with a new diagnosis of DCIS?  Will you be undergoing breast surgery? If so, you may be eligible to take part in this new research study.

Patients who agree to participate will be placed in either a study or placebo arm. Your participation includes: 0

  • Taking one pill a day for 3-5 weeks before your surgery
  • Providing 2 tablespoons of blood at the start and finish of the study
  • Keeping a drug and symptom diary
  • Filling out two surveys at the start and end of the study

If you would like to learn more about this study, please email Janna.Espinosa@hci.utah.edu or call 801-585-0571. HCI also offers more information on breast cancer and you can speak to a medical professional at the Breast Cancer Risk Clinic.