BRE-06: Study to Increase Tolerance to Aromatase Inhibitors for Patients With Early-Stage Hormone… (NCT07596212) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
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
United States100 participantsStarted 2026-07
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* Previous bilateral oophorectomy or ovarian irradiation; pregnant or…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is for people who developed hypoactive sexual desire disorder while taking aromatase inhibitors — does my situation match that, and is it something worth discussing with you as a potential option?
2Since this is a Phase 1/2 trial that hasn't started recruiting yet, what does that mean for how much we'd know about the safety and effectiveness of the study drugs before I'd be exposed to them?
3The trial is focused on improving tolerance to aromatase inhibitors — does that mean it's testing whether patients can stay on their aromatase inhibitor more comfortably, and how might that compare to other ways you might manage my side effects right now?
4Given that this study isn't recruiting yet, how long might it be before it opens, and are there standard treatments for hypoactive sexual desire disorder related to aromatase inhibitors that I should be considering in the meantime?
5What are the demands of participating in a trial like this — things like extra visits, monitoring, or stopping other medications — and how would that fit with my current treatment plan for early-stage breast cancer?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Tolerance of study drugs in patients with early stage breast cancer and Hypoactive Sexual Desire Disorder