Clinical Trial

BRE-06: Study to Increase Tolerance to Aromatase Inhibitors for Patients With Early-Stage Hormone Receptor Positive Breast Cancer Who Developed Hypoactive Sexual Desire Disorder

Not Yet Recruiting Phase 1/2
View on ClinicalTrials.gov →
Summary
This study is open to women who have early-stage breast cancer and are on aromatase inhibitor (AI) therapy, and who have hypoactive sexual desire disorder (HSDD). HSDD is a persistent lack of physical desire for sex and a lack of sexual activity, or even sexual thoughts or fantasies, that causes you distress. The researchers want to determine if sexual functioning, as measured by responses on a sexual functioning questionnaire, is improved by adding Bupropion Extended Release (XL) to the AI treatment regimen. Bupropion XL is an FDA-approved medication for the treatment of major depressive disorder, seasonal affective disorder, and nicotine dependence. It has been studied in HSDD in pre- and post-menopausal healthy women, and has been demonstrated to be effective, but it has not been thoroughly studied in women with early-stage breast cancer on AI therapy.
Protocol Amendment History 2 changes
notable Primary completion pushed: 2028-05 -> 2028-07 2026-06-19
minor Completion pushed: 2031-05 -> 2031-07 2026-06-19
Trial Details
NCT Number NCT07596212
Lead Sponsor University of Illinois at Chicago
Conditions Early-stage Breast Cancer, Hypoactive Sexual Desire Disorder, Hormone Receptor Positive Breast Carcinoma, Breast Cancer
Enrollment 100 participants
Start Date 2026-07
Primary Completion 2028-07 (estimated)
Study Completion 2031-07 (estimated)
Updated on ClinicalTrials.gov 2026-06-18