Breast Cancer Risk Research Study
Researchers are conducting a study in women with an increased risk of breast cancer to find out if a drug meant for relieving hot flashes can reduce that risk.
Fast Facts
Experiencing Hot Flashes or Night Sweats
45-64 Years Old
Conducted in Boston, Chicago, Kansas City, San Francisco, and Los Angeles
Study Background
Can a drug combination that’s meant to relieve hot flashes and prevent osteoporosis be used to reduce breast cancer risk?
The clinical trial involves taking two medicines — conjugated estrogen and bazedoxifene — orally each day for six months. This combination, when given as Duavee®, is FDA-approved for relief of hot flashes and prevention of osteoporosis in postmenopausal women.
- Conjugated estrogen relieves hot flashes and protects the bones.
- Bazedoxifene protects cells in the breast and uterus from stimulation by estrogen and protects the bones.
In our trial, we are exploring the possibility that the drug combination can also be used to reduce breast cancer risk. We will randomize women either to receive bazedoxifene and conjugated estrogen for six months right away or to wait for six months before starting the drug. Breast tissue will be sampled by a procedure that most women find reasonably comfortable, called fine needle aspiration.
This study is funded by the National Cancer Institute and involves participation by major cancer centers at:
- University of Kansas (Kansas City, KS)
- Dana-Farber Cancer Institute (Boston, MA)
- Northwestern University (Evanston, IL)
- City of Hope (Los Angeles, CA)
- University of California – San Francisco (San Francisco, CA)
Study Background
Can a drug combination that’s meant to relieve hot flashes and prevent osteoporosis be used to reduce breast cancer risk?
The clinical trial involves taking two medicines — conjugated estrogen and bazedoxifene — orally each day for six months. This combination, when given as Duavee®, is FDA-approved for relief of hot flashes and prevention of osteoporosis in postmenopausal women.
- Conjugated estrogen relieves hot flashes and protects the bones.
- Bazedoxifene protects cells in the breast and uterus from stimulation by estrogen and protects the bones.
In our trial, we are exploring the possibility that the drug combination can also be used to reduce breast cancer risk. We will randomize women either to receive bazedoxifene and conjugated estrogen for six months right away or to wait for six months before starting the drug. Breast tissue will be sampled by a procedure that most women find reasonably comfortable, called fine needle aspiration.
This study is funded by the National Cancer Institute and involves participation by major cancer centers at:
- University of Kansas (Kansas City, KS)
- Dana-Farber Cancer Institute (Boston, MA)
- Northwestern University (Evanston, IL)
- City of Hope (Los Angeles, CA)
- University of California – San Francisco (San Francisco, CA)
- The Ohio State University (Columbus, OH
Additional Information
The purpose of this trial is to determine if the combination of 2 drugs – bazedoxifene (an antiestrogen) and conjugated estrogen – is likely to reduce risk for breast cancer while reducing hot flashes. We will gain a good idea about the potential for breast cancer risk reduction by assessing changes in breast images, as well as certain molecular changes in breast tissue and blood.
You may qualify for a study if you meet the following criteria.
Inclusion Criteria:
- 45-64 years old
- Experience hot flashes or night sweats
- Have at least one of the following risk factors for breast cancer: family history of breast cancer, prior breast biopsies, prior non-invasive breast cancer, OR dense breasts on mammography
- No menstrual periods for at least 2 months
- Have stopped systemic hormones
Exclusion Criteria:
- Current breast implants
- Have had both ovaries removed
- Prior blood clots
- Use of anticoagulants
- Currently taking tamoxifen, raloxifene, or an aromatase inhibitor
Your participation in the study would last 6-12 months. Once enrolled, the study involves:
- Baseline: At baseline, we will ask potential participants to have a special type of mammogram, a blood draw, and a fine needle aspiration of breast tissue, as well as complete a questionnaire about their symptoms.
- Randomization: Eligible participants will randomized to either 1) immediately start taking bazedoxifene and conjugated estrogen for 6 months, or 2) wait 6 months before starting the drug combination.
- 6 Month Point: After 6 months, participants undergo mammography, blood draw, and another breast fine needle aspiration, and complete the questionnaire again. Participants who were randomized to immediately start the drug combination will be done with the study at this point. Those initially randomized to the waitlist control have the option to take 6 months of bazedoxifene and conjugated estrogen at this point.
As a participant, you will receive the study drugs at no cost. The study drugs will likely help with your hot flashes to the same extent that Duavee® would. More frequent mammograms provided by the study may detect breast cancer earlier. Additionally, you can be given results of some of your tests, including change in density and what the breast cells look like, if you wish to have them.
There is no cost for you to participate in our research study. All testing will be provided at the expense of the study.
