Breast Cancer Clinical Trial

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

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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Breast Cancer

Estimated Enrollment:

40

Study ID:

NCT03707340

Recruitment Status:

Recruiting

Sponsor:

Memorial Sloan Kettering Cancer Center

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There are 7 Locations for this study

See Locations Near You

Norwalk Hospital
Norwalk Connecticut, 06850, United States More Info
Linda Vahdat, MD
Contact
203-845-4811
Memoral Sloan Kettering Basking Ridge
Basking Ridge New Jersey, 07920, United States More Info
Shari Goldfarb, MD
Contact
646-888-5080
Memoral Sloan Kettering Monmouth
Middletown New Jersey, 07748, United States More Info
Shari Goldfarb, MD
Contact
646-888-5080
Memorial Sloan Kettering Cancer Center @ Commack
Commack New York, 11725, United States More Info
Shari Goldfarb, MD
Contact
646-888-5080
Memoral Sloan Kettering Westchester
Harrison New York, 10604, United States More Info
Shari Goldfarb, MD
Contact
646-888-5080
Memorial Sloan - Kettering Cancer Center
New York New York, 10021, United States More Info
Shari Goldfarb, MD
Contact
646-888-5080
Memorial Sloan Kettering Nassau
Uniondale New York, 11553, United States More Info
Shari Goldfarb, MD
Contact
646-888-5080

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

40

Study ID:

NCT03707340

Recruitment Status:

Recruiting

Sponsor:


Memorial Sloan Kettering Cancer Center

How clear is this clinincal trial information?

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