What is the PROMISE Study?
The PROMISE study focuses on preventing menopause symptoms and breast cancer invasion.
What do we hope to learn?
There are two main goals:
- We hope to answer whether this medication could prevent Ductal Carcinoma in Situ (DCIS) from developing into invasive breast cancer through its action on the milk ducts and surrounding tissue (stroma) in the breast.
- We want to see if this medication is safe for treatment of menopausal symptoms in women with a history of breast cancer.
What is Duavee?
The onset of menopause brings 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 treats menopausal symptoms without increasing the risk of breast, endometrial (uterus), or 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 immediately life-threatening, but DCIS become invasive breast cancer which is life-threatening. The reason to treat DCIS is to prevent it from advancing to invasive cancer.
What is the usual treatment for DCIS?
Due to its growth patterns, there can be different treatments for DCIS. Currently, DCIS is usually removed surgically and, in most cases, this is followed by medication that can cause menopausal side effects and radiation.
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.
Why consider a DCIS clinical trial?
We know that some women with the diagnosis of DCIS are over treated for their disease. Some treatments may negatively impact quality of life. This leaves women feeling that they have to compromise between quality of life considerations and reducing their risk of a future breast cancer. Participation in this trial can improve understanding of DCIS and advance treatment options that preserve quality of life for you and for other women. We appreciate you considering a trial and your care will not be affected by whether you choose to participate.
Who can participate in the study?
Are you a postmenopausal woman with a new diagnosis of DCIS? Is your DCIS estrogen receptor positive (ER+ >1%)? 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:
- 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.