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Not yet recruitingPhase 1 / Phase 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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 3 visits

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "FSFI will be administered at months 1, 3, 6, and during the year 3 visit."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether adding bupropion XL to aromatase inhibitors, medicines that lower estrogen, improves sexual function. It is for women with early-stage breast cancer that responds to hormones who take these medicines and have ongoing low sexual desire that causes distress.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Women age 18 or older.
  • Have stage I–III breast cancer that responds to hormones, confirmed by a tissue test and removed by surgery. Any HER2 status is allowed.
  • Have finished planned breast and lymph node surgery, radiation, and chemotherapy, if needed. Breast rebuilding surgery can still be pending. Anti-HER2 treatment is allowed.
  • Can do self-care and are out of bed or a chair for at least half of waking hours.
  • Can swallow medicine.
  • Can give written consent and fill out questionnaires.
  • Are willing to return to the study center for follow-up visits.
  • If able to become pregnant: are not pregnant or breastfeeding, have a negative pregnancy test, and use effective birth control from consent until 30 days after the last bupropion dose.

Who can't join

  • Have had both ovaries removed or radiation to the ovaries; are pregnant or breastfeeding; or want to become pregnant within 5 years.
  • Have a mental health condition under active treatment, any history of suicidal thoughts or actions, or currently take medicines for depression, anxiety, or psychosis.
  • Have a history of seizures, bulimia, or anorexia nervosa, which are eating disorders.
  • Take medicines that affect the liver enzyme CYP2B6, are processed by CYP2D6, or are called MAO inhibitors. The study team can check your medicines.
  • Have a history of high blood pressure, even if controlled, or angle-closure glaucoma, a type of eye disease.
  • Take levodopa, amantadine, methylene blue, or linezolid.
  • Are allergic to bupropion, anastrozole, letrozole, exemestane, goserelin, or leuprolide.
  • Are currently receiving radiation or cancer treatment that works throughout the body, such as standard or experimental chemotherapy. Anti-HER2 medicines are allowed.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 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

Study sites (1)

IL