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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

perjantai 21. elokuuta 2026 päivittänyt: 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.

Tutkimuksen yleiskatsaus

Tila

Ei vielä rekrytointia

Ehdot

Interventio / Hoito

Yksityiskohtainen kuvaus

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.

Opintotyyppi

Interventio

Ilmoittautuminen (Arvioitu)

100

Vaihe

  • Vaihe 2
  • Vaihe 1

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskeluyhteys

  • Nimi: Oana Danciu, MD
  • Puhelinnumero: (312) 355-1625
  • Sähköposti: ocdanciu@uic.edu

Tutki yhteystietojen varmuuskopiointi

  • Nimi: Michelle Karan
  • Puhelinnumero: (224) 563-7137
  • Sähköposti: makaran2@uic.edu

Opiskelupaikat

  • Yhdysvallat
    • Illinois
      • Chicago, Illinois, Yhdysvallat, 60612
        • University of Illinois at Chicago
        • Päätutkija:
          • Oana Danciu, MD
        • Ottaa yhteyttä:
        • Ottaa yhteyttä:

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

  • Aikuinen
  • Vanhempi Aikuinen

Hyväksyy terveitä vapaaehtoisia

Ei

Kuvaus

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

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Ei mitään (avoin tarra)

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Active Comparator: 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.
Lääke: Aromatase Inhibitors
An aromatase inhibitor will be given at a duration, frequency, and dose per standard of care.
Muut nimet:
  • Eksemestaani
  • Letrotsoli
  • Anastrotsoli
Lääke: 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.
Muut nimet:
  • Leuprolidi
  • Gosereliini
Active Comparator: 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.
Lääke: Aromatase Inhibitors
An aromatase inhibitor will be given at a duration, frequency, and dose per standard of care.
Muut nimet:
  • Eksemestaani
  • Letrotsoli
  • Anastrotsoli
Kokeellinen: 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.
Lääke: Aromatase Inhibitors
An aromatase inhibitor will be given at a duration, frequency, and dose per standard of care.
Muut nimet:
  • Eksemestaani
  • Letrotsoli
  • Anastrotsoli
Lääke: 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.
Muut nimet:
  • Leuprolidi
  • Gosereliini
Lääke: 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
Muut nimet:
  • Wellbutrin
  • Zyban
Kokeellinen: 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.
Lääke: Aromatase Inhibitors
An aromatase inhibitor will be given at a duration, frequency, and dose per standard of care.
Muut nimet:
  • Eksemestaani
  • Letrotsoli
  • Anastrotsoli
Lääke: 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
Muut nimet:
  • Wellbutrin
  • Zyban

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Tolerance of study drugs in patients with early stage breast cancer and Hypoactive Sexual Desire Disorder
Aikaikkuna: 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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Disease free-survival in patients with early stage breast cancer and Hypoactive Sexual Desire Disorder
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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

Muut tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Prevalence and response to treatment of Hypoactive Sexual Desire Disorder in patients with early stage breast cancer across different racial groups
Aikaikkuna: 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

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

University of Illinois at Chicago

Tutkijat

  • Päätutkija: Oana Danciu, MD, University of Illinois at Chicago

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

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