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

Sponsor
Memorial Sloan Kettering Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT03707340
Collaborator
(none)
37
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59.6
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Study Details

Study Description

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 Phase
  • Drug: Flibanserin Pill

Study Design

Study Type:
Observational
Anticipated 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 :
Sep 14, 2018
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm 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

Primary Outcome Measures

  1. 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.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Norwalk Hospital Norwalk Connecticut United States 06850
2 Memoral Sloan Kettering Basking Ridge Basking Ridge New Jersey United States 07920
3 Memoral Sloan Kettering Monmouth Middletown New Jersey United States 07748
4 Memorial Sloan Kettering Cancer Center @ Commack Commack New York United States 11725
5 Memoral Sloan Kettering Westchester Harrison New York United States 10604
6 Memorial Sloan - Kettering Cancer Center New York New York United States 10021
7 Memorial Sloan Kettering Nassau Uniondale New York United States 11553

Sponsors and Collaborators

  • Memorial Sloan Kettering Cancer Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT03707340
Other Study ID Numbers:
  • 18-109
First Posted:
Oct 16, 2018
Last Update Posted:
May 26, 2022
Last Verified:
May 1, 2022
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 26, 2022