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

NCT07596212 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 2025-1138
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Tolerance of study drugs in patients with early stage breast cancer and Hypoactive Sexual Desire Disorder

  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.

  Until 3 months post-study enrollment

Secondary Outcomes (4)

• Disease free-survival in patients with early stage breast cancer and Hypoactive Sexual Desire Disorder

  Until 3 years post-study enrollment

• Overall survival in patients with early stage breast cancer and Hypoactive Sexual Desire Disorder

  Until 3 years post-study enrollment

• Safety and tolerability of study drugs in patients with early stage breast cancer and Hypoactive Sexual Desire Disorder

  Until 6 months post-study enrollment

• Medication adherence of study drugs in patients with early stage breast cancer and Hypoactive Sexual Desire Disorder

  Until 3 years post-treatment start

Other Outcomes (1)

• Prevalence and response to treatment of Hypoactive Sexual Desire Disorder in patients with early stage breast cancer across different racial groups

  Until 3 years post-treatment start

Study Arms (4)

Single Agent Aromatase Inhibitor and Gonadotropin-Releasing Hormone (GnRH) Agonist

ACTIVE COMPARATOR

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.

Drug: Aromatase Inhibitors; Drug: GnRH agonist

Single Agent Aromatase Inhibitor

ACTIVE COMPARATOR

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.

Drug: Aromatase Inhibitors

Single Agent Aromatase Inhibitor, Gonadotropin-Releasing Hormone (GnRH) Agonist, and Bupropion

EXPERIMENTAL

Participants will receive aromatase inhibitor as part of standard of care for early stage breast cancer plus bupropion 150 mg orally twice daily. 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). Patients with Hypoactive Sexual Desire Disorder will also have the option to change their dose to 300 mg orally once a day. 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.

Drug: Aromatase Inhibitors; Drug: Bupropion; Drug: GnRH agonist

Single Agent Aromatase Inhibitor and Bupropion

EXPERIMENTAL

Participants will receive aromatase inhibitor as part of standard of care for early stage breast cancer plus bupropion 150 mg orally twice daily. 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). Patients with Hypoactive Sexual Desire Disorder will also have the option to change their dose to 300 mg orally once a day.

Drug: Aromatase Inhibitors; Drug: Bupropion

Interventions

Aromatase Inhibitors DRUG

An aromatase inhibitor will be given at a duration, frequency, and dose per standard of care.

Also known as: Letrozole, Anastrozole, Exemestane

Single Agent Aromatase Inhibitor; Single Agent Aromatase Inhibitor and Bupropion; Single Agent Aromatase Inhibitor and Gonadotropin-Releasing Hormone (GnRH) Agonist; Single Agent Aromatase Inhibitor, Gonadotropin-Releasing Hormone (GnRH) Agonist, and Bupropion

Bupropion DRUG

Bupropion will be taken twice a day by mouth at 150 mg with the option to change to 300 mg daily for those with ongoing HSDD symptoms

Also known as: Wellbutrin, Zyban

Single Agent Aromatase Inhibitor and Bupropion; Single Agent Aromatase Inhibitor, Gonadotropin-Releasing Hormone (GnRH) Agonist, and Bupropion

GnRH agonist DRUG

A GnRH agonist will be administered for a duration and dose per standard of care as part of ovarian suppression therapy for those who are pre-menopausal. These will be administered subcutaneously every 28 days.

Also known as: Leuprolide, Goserelin

Single Agent Aromatase Inhibitor and Gonadotropin-Releasing Hormone (GnRH) Agonist; Single Agent Aromatase Inhibitor, Gonadotropin-Releasing Hormone (GnRH) Agonist, and Bupropion

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Sexual Dysfunctions, Psychological

Interventions

Aromatase Inhibitors; Letrozole; Anastrozole; exemestane; Bupropion; Gonadotropin-Releasing Hormone; Leuprolide; Goserelin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Estrogen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Propiophenones; Ketones; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Oana Danciu, MD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oana Danciu, MD

CONTACT

(312) 355-1625; ocdanciu@uic.edu

Michelle Karan

CONTACT

(224) 563-7137; makaran2@uic.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: May 19, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2031
• Last Updated: May 19, 2026

Record last verified: 2026-05

Locations

US (1)