A Study of Flibanserin in Breast Cancer Survivors on Tamoxifen

Inclusion Criteria:

- Pre- or perimenopausal women at least 21 years of age

- 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.

- Has been taking tamoxifen 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

- 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 have no alcohol consumption during the 24 weeks of treatment on
study

- English speaking

- Able to participate in the informed consent process

Exclusion Criteria:

- Active secondary cancer requiring cytotoxic chemotherapy

- History or current diagnosis of metastatic breast cancer.

- Unwillingness to abstain from alcohol use while taking flibanserin

- Hepatic dysfunction (more than 2 times the upper limit of normal for alt, ast, t.bili
or alk phos) proven by Comprehensive Metabolic Panel (CMP) performed within 6 months
of protocol enrollment and while the patient was on Tamoxifen

- Patients on strong CYP3A4 inhibitors including ketoconazole, itraconazole,
posaconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir,
indinavir, boceprevir, telaprevir, telithromycin, conivaptan

- Patients on moderate CYP3A4 inhibitors including Amprenavir, atazanavir,
ciprofloxacin, diltiazem, erythromycin, fluconazole, fosamprenavir, verapamil,
grapefruit juice

- Non-English speaking

- Unable to participate in the informed consent process