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Study for Aromatase Inhibitor Tolerance and Hypoactive Sexual Desire Disorder

This study is for women aged 18 and older who have early-stage breast cancer that is hormone receptor-positive (meaning it grows in response to hormones like estrogen or progesterone) and are taking aromatase inhibitors (AIs). It focuses on those who have also developed hypoactive sexual desire disorder (HSDD), which is a persistent lack of sexual desire causing distress. Researchers want to see if adding Bupropion Extended Release (XL) to AI treatment can improve sexual functioning. Participants will discontinue their current AI and be randomized to receive a different AI plus Bupropion 150 mg twice daily, or a single AI. All participants with HSDD will also receive counseling and pelvic floor therapy. The main goal is to see how well patients tolerate the study drugs over three months.

Study design
This is an interventional study with a planned enrollment of 100 women. Participants will be randomized to receive either a different aromatase inhibitor plus bupropion, or a single aromatase inhibitor.
What's involved
You would take Bupropion twice a day by mouth, with an option to increase the dose. If pre-menopausal, you would also receive a GnRH agonist injection every 28 days. You will complete a sexual functioning questionnaire at months 1, 3, 6, and during a year 3 visit.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for drug tolerance is measured until 3 months after you enroll in the study. Sexual functioning will be assessed at months 1, 3, 6, and during the year 3 visit.

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NCT07596212

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
PHASE1Ages 18+InterventionalTreatment
University of Illinois at Chicago
~100 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:Aromatase InhibitorsBupropionGnRH agonist

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Tolerance of study drugs in patients with early stage breast cancer and Hypoactive Sexual Desire Disorder
Measured over Until 3 months post-study enrollment

Conditions

Early-stage Breast Cancer
Hypoactive Sexual Desire Disorder
Hormone Receptor Positive Breast Carcinoma
Breast Cancer

Explore related trials

Breast CarcinomaHypoactive Sexual Desire Disorder

Where it's being run

1 sites across 1 states
Illinois1

Study leadership

  • Oana Danciu, MD · PRINCIPAL_INVESTIGATOR · University of Illinois at Chicago

Who to contact

Oana Danciu, MD
[email protected]
(312) 355-1625
Email the study team

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Eligibility criteria

Inclusion

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
Completion of the following planned cancer treatments prior to registration:
Surgical resection of breast and nodal surgery; (NOTE: Reconstructive surgery does not have to be completed)
Adjuvant radiation therapy, if needed
Neoadjuvant and/or adjuvant chemotherapy if needed
Treatment with anti-HER2 agents is allowed
Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
Ability to swallow oral medication.
Provide written informed consent and fill out questionnaires
Willing to return to the enrolling institution for follow-up
Women of childbearing potential must not be pregnant or breastfeeding. A negative serum or urine pregnancy test is required per institutional practice guidelines. Women of childbearing potential will be required to use effective contraception from the time of consent until 30 days after the last dose of bupropion. Acceptable methods include hormonal contraception, intrauterine device, barrier methods with spermicide, or sterilization

Exclusion

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
History of bulimia or anorexia nervosa
Inhibitors or inducers of CYP2B6
Drugs metabolized by CYP2D6
Use of monoamine oxidase inhibitors (MAOI)
History of hypertension, regardless of control status.
History of angle closure glaucoma
Subjects taking levodopa, amantadine, methylene blue, and linezolid
Those with a hypersensitivity to bupropion, anastrozole, letrozole, exemestane, goserelin, or leuprolide. Currently receiving any of the following cancer-directed therapies:
Radiation therapy
Systemic therapy such as chemotherapy (standard or investigational)
Anti-HER2 agents are allowed

What this trial measures

  • Tolerance of study drugs in patients with early stage breast cancer and Hypoactive Sexual Desire DisorderUntil 3 months post-study enrollment

    To compare the tolerance of aromatase inhibitor (+/- ovarian suppression therapy) in comparison to aromatase inhibitor (+/- ovarian suppression therapy) plus bupropion. This is assessed by the proportion of patients no longer meeting HSDD criteria as reflected by FSFI \> 26 at three months post-randomization.