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

Active, not recruiting

• Conditions: Breast Cancer; Hyposexual Desire Disorder
• Interventions: Drug: Flibanserin Pill

• Registration Number: NCT03707340
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-09-14
• Study First Submitted: 2018-09-17
• Study First Submitted QC: 2018-10-11
• Study First Posted: 2018-10-16
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-15
• Last Update Posted: 2024-10-16
• Primary Completion: 2025-10-14
• Study Completion: 2025-10-14

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 43

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Breast Cancer Pts with hyposexual desire disorder/HSDD	Flibanserin Pill	-

Primary Outcome Measures

Name	Time	Method
Discontinuation rate of flibanserin in women with breast cancer on Tamoxifen with disease or medical induced hypoactive sexual desire disorder	1 year	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.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of flibanserin	1 year	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.

Trial Locations

Locations (7)

Memorial Sloan - Kettering Cancer Center; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Westchester; 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Nassau; 🇺🇸 Uniondale, New York, United States

Memorial Sloan Kettering Cancer Center @ Commack; 🇺🇸 Commack, New York, United States

Norwalk Hospital; 🇺🇸 Norwalk, Connecticut, United States

Memorial Sloan Kettering Basking Ridge; 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth; 🇺🇸 Middletown, New Jersey, United States