Flibanserin in Improving Quality of Life in Stage 0-III Breast Cancer Survivors
This phase II trial studies how well flibanserin works in improving quality of life in stage 0-III breast cancer survivors. Flibanserin may help to minimize the hyposexual desire disorder so as to improve overall quality of life in breast cancer survivors.
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 aromatase inhibitor (AI), or ovarian suppression
- Has been taking tamoxifen, an AI, or ovarian suppression for at least 3 months
- Has liver function tests (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 Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV and International Society for the Study of Women's Sexual Health (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 24-36 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 follow alcohol guidelines while taking flibanserin
- Hepatic dysfunction (more than 2 times the upper limit of normal for alanine aminotransferase [alt], aspartate aminotransferase [ast], total bilirubin [t.bili] or alkaline phosphatase [alk phos]) proven by comprehensive metabolic panel (CMP) performed within 6 months of protocol enrollment and while the patient was on tamoxifen or an AI
- 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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03707340.
PRIMARY OBJECTIVE:
I. To evaluate the feasibility defined as the treatment discontinuation rate of flibanserin for 24-36 weeks due to toxicity, withdrawal of consent or other event related to tolerability.
SECONDARY OBJECTIVES:
I. To measure the change in the number of satisfying sexual events (SSE) and sexual desire via the Female Sexual Function Index (FSFI) desire domain in female breast cancer survivors with hyposexual desire disorder (HSDD) on flibanserin from baseline to eight weeks.
II. Measure and describe changes in distress related to sexual desire and dysfunction using the Female Sexual Distress Scale – Revised (FSDS-R) throughout the study.
III. Measure and describe changes in overall sexual functioning and sexual desire using FSFI total score, Patient Reported Outcomes Measurement Information System (PROMIS)-sexual function (SF), number of sexual encounters, and number of satisfying sexual events (SSE) throughout the study.
IV. Measure and describe changes in perception of sexual functioning, body image, health related quality of life (QoL), weight and sleep throughout the study.
V. To assess sexual desire and sexual function at week 52 to assess long-term, and persistent benefit from flibanserin.
VI. To evaluate overall symptom improvement and patient satisfaction throughout the study.
OUTLINE:
Participants receive flibanserin orally (PO) once daily (QD) for 16-24 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study, participants are followed up for 52 weeks.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorShari Beth Goldfarb
- Primary ID18-109
- Secondary IDsNCI-2018-02419
- ClinicalTrials.gov IDNCT03707340