Clinical trial · Interventional
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
NCT07596212CI-TRIAL-00123518not yet recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Early-stage Breast Cancer | Early Stage Breast Carcinoma | ALIAS | 0.90 |
| Hormone Receptor Positive Breast Carcinoma | Hormone Receptor-Positive Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Hypoactive Sexual Desire Disorder | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aromatase Inhibitors | Drug | — | UNRESOLVED |
| Bupropion | Drug | — | UNRESOLVED |
| GnRH agonist | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- Single Agent Aromatase Inhibitor and Gonadotropin-Releasing Hormone (GnRH) Agonist
- description
- Participants will receive aromatase inhibitor as part of standard of care for early stage breast cancer. The duration of AI therapy will be at the discretion of the investigator. Patients who are diagnosed with Hypoactive Sexual Desire Disorder at baseline will discontinue their current aromatase inhibitor treatment and switch to a different aromatase inhibitor treatment (i.e., non-steroidal AI to steroidal AI, or vice versa). Those who are pre-menopausal will also be treated with ovarian suppression therapy (in the form of a GnRH agonist) per standard of care. They will be treated by subcutaneous injection every 28 days and the type, duration, and dose of drug will be per the treating physician's discretion. Those who have ongoing Hypoactive Sexual Desire Disorder symptoms have the option to crossover to the bupropion arm.
- interventionNames
- Drug: Aromatase Inhibitors
- Drug: GnRH agonist
- type
- ACTIVE_COMPARATOR
- label
- Single Agent Aromatase Inhibitor
- description
- Participants will receive aromatase inhibitor as part of standard of care for early stage breast cancer. The duration of AI therapy will be at the discretion of the investigator. Patients who are diagnosed with Hypoactive Sexual Desire Disorder at baseline will discontinue their current aromatase inhibitor treatment and switch to a different aromatase inhibitor treatment (i.e., non-steroidal AI to steroidal AI, or vice versa). Those who have ongoing Hypoactive Sexual Desire Disorder symptoms have the option to crossover to the bupropion arm.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.