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
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.
Timeline
- Start
- 2026-07
- Primary completion
- 2028-07
- Completion
- 2031-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bupropion | Small molecule | 150 mg | Oral |
| Subject | Bupropion | Small molecule | 300 mg | Oral |
| Background | Anastrozole | Other / unclassified | — | — |
| Background | Exemestane | Small molecule | — | — |
| Background | Goserelin | Other / unclassified | — | Subcutaneous |
| Background | Letrozole | Other / unclassified | — | — |
| Background | Leuprolide | Other / unclassified | — | Subcutaneous |