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

Recruiting at 9 trial locations

Overseen By Jeanne Carter, PhD

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Must be taking: Tamoxifen, AI, ovarian suppression

Must not be taking: Strong CYP3A4 inhibitors

Disqualifiers: Metastatic cancer, Hepatic dysfunction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

43 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Shari Goldfarb, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

Inclusion Criteria

Able to swallow tablets

Women age 21 and older

History of stage 0-III breast cancer that is estrogen and/or progesterone receptor positive

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Flibanserin and Tamoxifen to evaluate feasibility and effects on hyposexual desire disorder

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Flibanserin

Participant Groups

Group I: Breast Cancer Pts with hyposexual desire disorder/HSDD Experimental Treatment 1 Intervention

Flibanserin is already approved in United States for the following indications:

Approved in United States as Addyi for:

• Hypoactive Sexual Desire Disorder (HSDD) in premenopausal women

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+