About this trial

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.

Eligibility criteria

Qualifiers

Females 18 or older

Histologically-proven, resected, hormone receptor-positive (defined as estrogen receptor ≥1% and/or progesterone receptor (PgR)≥1% by immunohistochemistry at local institutions) early invasive breast cancer, stage I-III per American Joint Committee of Cancer (AJCC) 8th edition, regardless of Human Epidermal growth factor Receptor 2 (HER2) status

Surgical resection of breast and nodal surgery; (NOTE: Reconstructive surgery does not have to be completed)

Adjuvant radiation therapy, if needed

Disqualifiers

Previous bilateral oophorectomy or ovarian irradiation; pregnant or lactating at the time of randomization or desiring pregnancy within 5 years.

History of psychiatric illnesses on active treatment

History or active suicidal thoughts or behaviors

Currently taking anti-depressants, anti-anxiety, or anti-psychotic medications. History of seizure disorder

Trial design

Treatments tested in this trial

  • Aromatase Inhibitors
  • Bupropion
  • GnRH agonist

Treatment groups

100 Participants
are divided into 4 treatment groups

Locations

1
University of Illinois at Chicago60612, ChicagoIllinois, United States

Sponsors and collaborators

University of Illinois at Chicago

Lead sponsor