A Study of Flibanserin in Breast Cancer Survivors on Tamoxifen



Status:Recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:21 - Any
Updated:10/20/2018
Start Date:September 14, 2018
End Date:September 2019
Contact:Shari Goldfarb, MD
Email:goldfars@mskcc.org
Phone:646-888-5080

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A Feasibility of Flibanserin in Breast Cancer Survivors on Tamoxifen

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.


Inclusion Criteria:

- Pre- or perimenopausal women at least 21 years of age

- 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.

- Has been taking tamoxifen 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

- 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 have no 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 abstain from alcohol use 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

- 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
We found this trial at
6
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480 Red Hill Road
Middletown, New Jersey 07748
Phone: 646-888-5080
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136 Mountainview Boulevard
Basking Ridge, New Jersey 07920
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650 Commack Rd
Commack, New York 11725
(631) 623-4000
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Memorial Sloan-Kettering Cancer Center at Commack Memorial Sloan Kettering Cancer Center - the world's oldest...
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Harrison, New York
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1275 York Ave
New York, New York 10021
(212) 639-2000
Phone: 646-888-5080
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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1000 North Village Avenue
Rockville Centre, New York 11570
Phone: 646-888-5080
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Rockville Centre, NY
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