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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03707340
• Other study ID #: 18-109
• Status: Active, not recruiting
• Start date: September 14, 2018
• Est. completion date: September 2025

Study information

• Verified date: May 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine if it is feasible for women to take both Flibanserin and tamoxifen for the duration of the study. This study is also trying to find out if Flibanserin improves or has any effect on hyposexual desire disorder/HSDD in women who are taking tamoxifen for breast cancer.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 43
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

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 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 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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Hyposexual Desire Disorder

Intervention

Drug:
• Flibanserin Pill
Eligible participants will begin treatment with flibanserin 100 mg orally daily at bedtime for 24-36 weeks and followed for a total of 52 weeks.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Cancer Center @ Commack	Commack	New York
United States	Memorial Sloan Kettering Westchester	Harrison	New York
United States	Memorial Sloan Kettering Monmouth	Middletown	New Jersey
United States	Memorial Sloan - Kettering Cancer Center	New York	New York
United States	Norwalk Hospital	Norwalk	Connecticut
United States	Memorial Sloan Kettering Nassau	Uniondale	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Discontinuation rate of flibanserin in women with breast cancer on Tamoxifen with disease or medical induced hypoactive sexual desire disorder	To evaluate the feasibility defined as the treatment discontinuation rate of flibanserin for 24 weeks due to toxicity, withdrawal of consent or other events related to tolerability.	1 year
Primary	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of flibanserin	The AE reporting period begins on the first day of study drug administration and continues until 4 weeks after the patient has taken the last dose of study drug. AE's will be evaluated using CTCAE v 4.	1 year

External Links

•   Memorial Sloan Kettering Cancer Center