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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

13. maj 2026 opdateret af: Oana Danciu, University of Illinois at Chicago
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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Patients diagnosed with HSDD (defined as Female Sexual Function Index, or FSFI, score ≤ 26) will discontinue their current AI therapy and will be randomized to treatment with a different AI (non-steroidal AI to steroidal AI, or vice versa) plus bupropion 150 mg orally twice a day versus single-agent AI. All patients diagnosed with HSDD will be referred to counseling services and pelvic floor therapy. In addition, patients will be offered access to the Rosy App. FSFI will be administered at months 1, 3, 6, and during the year 3 visit.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

100

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Forenede Stater
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612
        • University of Illinois at Chicago
        • Ledende efterforsker:
          • Oana Danciu, MD
        • Kontakt:
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Single Agent Aromatase Inhibitor and Gonadotropin-Releasing Hormone (GnRH) Agonist

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.
Medicin: Aromatase Inhibitors
An aromatase inhibitor will be given at a duration, frequency, and dose per standard of care.
Andre navne:
  • Exemestan
  • Letrozol
  • Anastrozol
Medicin: GnRH agonist
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.
Andre navne:
  • Leuprolid
  • Goserelin
Aktiv komparator: Single Agent Aromatase Inhibitor

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.
Medicin: Aromatase Inhibitors
An aromatase inhibitor will be given at a duration, frequency, and dose per standard of care.
Andre navne:
  • Exemestan
  • Letrozol
  • Anastrozol
Eksperimentel: Single Agent Aromatase Inhibitor, Gonadotropin-Releasing Hormone (GnRH) Agonist, and Bupropion

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.
Medicin: Aromatase Inhibitors
An aromatase inhibitor will be given at a duration, frequency, and dose per standard of care.
Andre navne:
  • Exemestan
  • Letrozol
  • Anastrozol
Medicin: GnRH agonist
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.
Andre navne:
  • Leuprolid
  • Goserelin
Medicin: Bupropion
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
Andre navne:
  • Wellbutrin
  • Zyban
Eksperimentel: Single Agent Aromatase Inhibitor and Bupropion

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.
Medicin: Aromatase Inhibitors
An aromatase inhibitor will be given at a duration, frequency, and dose per standard of care.
Andre navne:
  • Exemestan
  • Letrozol
  • Anastrozol
Medicin: Bupropion
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
Andre navne:
  • Wellbutrin
  • Zyban

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Tolerance of study drugs in patients with early stage breast cancer and Hypoactive Sexual Desire Disorder
Tidsramme: Until 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.
Until 3 months post-study enrollment

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Disease free-survival in patients with early stage breast cancer and Hypoactive Sexual Desire Disorder
Tidsramme: Until 3 years post-study enrollment
To compare the disease free survival rate of patients taking aromatase inhibitor (+/- ovarian suppression therapy) to those taking aromatase inhibitor therapy (+/- ovarian suppression therapy) plus bupropion. This is assessed by the time since treatment end to the date of disease progression, death, or least contact, whichever comes first
Until 3 years post-study enrollment
Overall survival in patients with early stage breast cancer and Hypoactive Sexual Desire Disorder
Tidsramme: Until 3 years post-study enrollment
To compare the overall survival rate of patients taking aromatase inhibitor (+/- ovarian suppression therapy) to those taking aromatase inhibitor therapy (+/- ovarian suppression therapy) plus bupropion. This is defined as the time of treatment randomization to death or last contact in study participants.
Until 3 years post-study enrollment
Safety and tolerability of study drugs in patients with early stage breast cancer and Hypoactive Sexual Desire Disorder
Tidsramme: Until 6 months post-study enrollment
To determine the safety and tolerability of aromatase inhibitor (+/- ovarian suppression therapy) versus aromatase inhibitor (+/- ovarian suppression therapy) and bupropion as defined by the number of adverse events using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.
Until 6 months post-study enrollment
Medication adherence of study drugs in patients with early stage breast cancer and Hypoactive Sexual Desire Disorder
Tidsramme: Until 3 years post-treatment start
To determine the rate of medication adherence for patients taking aromatase inhibitor (+/- ovarian suppression therapy) versus aromatase inhibitor (+/- ovarian suppression therapy) and bupropion. This is defined as the number of medication diary entries and physician queries to treatment.
Until 3 years post-treatment start

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Prevalence and response to treatment of Hypoactive Sexual Desire Disorder in patients with early stage breast cancer across different racial groups
Tidsramme: Until 3 years post-treatment start
Prevalence of Hypoactive Sexual Desire Disorder among different racial groups will be assessed by the number of of early breast cancer patients with HSDD who are African-American, Caucasian, and Hispanic while the response to treatment across racial groups will be calculated by the overall decrease in FSFI score for the groups.
Until 3 years post-treatment start

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Illinois at Chicago

Efterforskere

  • Ledende efterforsker: Oana Danciu, MD, University of Illinois at Chicago

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. maj 2026

Primær færdiggørelse (Anslået)

1. maj 2028

Studieafslutning (Anslået)

1. maj 2031

Datoer for studieregistrering

Først indsendt

13. maj 2026

Først indsendt, der opfyldte QC-kriterier

13. maj 2026

Først opslået (Faktiske)

19. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2025-1138

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

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