Randomized double blind phase 2 trial of baby exemestaneversus baby tamoxifen in post-menopausal women at highrisk for breast cancer.BabyTEARS (Baby Tamoxifen or Exemestane AssessmentRandomized Study)

This study wants to find out if a low dose of BabytamTamoxifen (called Babytam) works better than a low dose of Babyexe Exemestane (called Babyexe) in helping with physical problems like joint pain. We will check this using a special questionnaire about menopause symptoms after 12 months of treatment. This questionnaire is a trusted way to see how menopause or low estrogen affects women, and how these medicines might change those symptoms. This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of the investigational drugs, to learn whether the drug works in treating a specific disease. “Investigational” means that the drug is being studied and not approved by The U.S. Food and Drug Administration (FDA). The FDA has approved Tamoxifene and Exemestane as a treatment option for your condition.

Are you Eligible? (Inclusion Criteria)

• Pre/perimenopausal women (amenorrhea < 6 months and FSH<45 mU/mL) are not eligible because of risk of uncontrolled ovarian stimulation with exemestane. 2. History of DVT or PE. 3. Endometrial cancer. 4. Macular disorders. 5. Inability to comply with study procedures.