A Study of Flibanserin in Breast Cancer Survivors on Tamoxifen or Aromatase Inhibitors

Inclusion Criteria

• •Women age 21 and older
• •Able to swallow tablets
• •History of stage 0-III breast cancer that is estrogen and/or progesterone receptor positive
• •History of breast cancer with no current evidence of disease and have completed primary treatment with any combination of surgery, radiation and/or chemotherapy at least 3 months ago and is currently on Tamoxifen, an AI, or ovarian suppression.
• •Has been taking tamoxifen, an AI, ,or ovarian suppression for at least 3 months.
• •Has LFTS within 2 times the upper limit of normal proven by a Comprehensive Metabolic Panel (CMP) performed within 6 months of protocol enrollment and while the patient was on Tamoxifen, an AI, or ovarian suppression
• •Patients meet criteria for the diagnosis of HSDD as defined by the DSM-IV and ISSWSH Consensus paper. The criteria states that there must be a decrease in sexual desire and this must be a change for at least 3 months from what it was previously. Personal distress resulting from this change must occur. Initial screening will take place with The Decreased Sexual Desire Screener, a 5-question screening tool developed and validated to aid clinicians in making the diagnosis of HSDD. A "yes" response to the first 4 questions on the screener is consistent with HSDD.
• •Patients must agree to follow the guidelines for alcohol consumption during the 24 weeks of treatment on study
• •English speaking
• •Able to participate in the informed consent process