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

May 24, 2023 updated by: Memorial Sloan Kettering Cancer Center

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

43

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Norwalk, Connecticut, United States, 06850
        • Norwalk Hospital
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Memorial Sloan Kettering Basking Ridge
      • Middletown, New Jersey, United States, 07748
        • Memorial Sloan Kettering Monmouth
    • New York
      • Commack, New York, United States, 11725
        • Memorial Sloan Kettering Cancer Center @ Commack
      • Harrison, New York, United States, 10604
        • Memorial Sloan Kettering Westchester
      • New York, New York, United States, 10021
        • Memorial Sloan - Kettering Cancer Center
      • Uniondale, New York, United States, 11553
        • Memorial Sloan Kettering Nassau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Premenopausal women on Tamoxifen with early stage breast cancer who have completed primary treatment with surgery, radiation and chemotherapy and have hypoactive sexual desire disorder (HSDD)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Breast Cancer Pts with hyposexual desire disorder/HSDD
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Shari Goldfarb, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2018

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

September 17, 2018

First Submitted That Met QC Criteria

October 11, 2018

First Posted (Actual)

October 16, 2018

Study Record Updates

Last Update Posted (Actual)

May 25, 2023

Last Update Submitted That Met QC Criteria

May 24, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-109

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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