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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03707340
Recruitment Status : Recruiting
First Posted : October 16, 2018
Last Update Posted : May 26, 2022
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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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.

Condition or disease Intervention/treatment
Breast Cancer Hyposexual Desire Disorder Drug: Flibanserin Pill

Study Design
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Study Type : Observational
Estimated Enrollment : 37 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Feasibility Study of Flibanserin in Breast Cancer Survivors on Tamoxifen and Aromatase Inhibitors
Actual Study Start Date : September 14, 2018
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2023

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Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
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)
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03707340


Contacts
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Contact: Shari Goldfarb, MD 646-888-5080 goldfars@mskcc.org
Contact: Jeanne Carter, PhD 646-888-5076 carterj@mskcc.org

Locations
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United States, Connecticut
Norwalk Hospital Recruiting
Norwalk, Connecticut, United States, 06850
Contact: Linda Vahdat, MD    203-845-4811      
United States, New Jersey
Memoral Sloan Kettering Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Shari Goldfarb, MD    646-888-5080      
Memoral Sloan Kettering Monmouth Recruiting
Middletown, New Jersey, United States, 07748
Contact: Shari Goldfarb, MD    646-888-5080      
United States, New York
Memorial Sloan Kettering Cancer Center @ Commack Recruiting
Commack, New York, United States, 11725
Contact: Shari Goldfarb, MD    646-888-5080      
Memoral Sloan Kettering Westchester Recruiting
Harrison, New York, United States, 10604
Contact: Shari Goldfarb, MD    646-888-5080      
Memorial Sloan - Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Shari Goldfarb, MD    646-888-5080      
Memorial Sloan Kettering Nassau Recruiting
Uniondale, New York, United States, 11553
Contact: Shari Goldfarb, MD    646-888-5080      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Shari Goldfarb, MD Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03707340    
Other Study ID Numbers: 18-109
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: May 26, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
tamoxifen
Flibanserin
hyposexual desire disorder
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases