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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

21 sierpnia 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

100

Faza

  • Faza 2
  • Faza 1

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

  • Nazwa: Oana Danciu, MD
  • Numer telefonu: (312) 355-1625
  • E-mail: ocdanciu@uic.edu

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

  • Stany Zjednoczone
    • Illinois
      • Chicago, Illinois, Stany Zjednoczone, 60612
        • University of Illinois at Chicago
        • Główny śledczy:
          • Oana Danciu, MD
        • Kontakt:
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny 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.
Lek: Aromatase Inhibitors
An aromatase inhibitor will be given at a duration, frequency, and dose per standard of care.
Inne nazwy:
  • Eksemestan
  • Letrozol
  • Anastrozol
Lek: 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.
Inne nazwy:
  • Leuprolid
  • Goserelina
Aktywny 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.
Lek: Aromatase Inhibitors
An aromatase inhibitor will be given at a duration, frequency, and dose per standard of care.
Inne nazwy:
  • Eksemestan
  • Letrozol
  • Anastrozol
Eksperymentalny: 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.
Lek: Aromatase Inhibitors
An aromatase inhibitor will be given at a duration, frequency, and dose per standard of care.
Inne nazwy:
  • Eksemestan
  • Letrozol
  • Anastrozol
Lek: 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.
Inne nazwy:
  • Leuprolid
  • Goserelina
Lek: 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
Inne nazwy:
  • Wellbutrin
  • Zyban
Eksperymentalny: 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.
Lek: Aromatase Inhibitors
An aromatase inhibitor will be given at a duration, frequency, and dose per standard of care.
Inne nazwy:
  • Eksemestan
  • Letrozol
  • Anastrozol
Lek: 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
Inne nazwy:
  • Wellbutrin
  • Zyban

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Tolerance of study drugs in patients with early stage breast cancer and Hypoactive Sexual Desire Disorder
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Disease free-survival in patients with early stage breast cancer and Hypoactive Sexual Desire Disorder
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Prevalence and response to treatment of Hypoactive Sexual Desire Disorder in patients with early stage breast cancer across different racial groups
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of Illinois at Chicago

Śledczy

  • Główny śledczy: Oana Danciu, MD, University of Illinois at Chicago

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 września 2026

Zakończenie podstawowe (Szacowany)

1 września 2028

Ukończenie studiów (Szacowany)

1 września 2031

Daty rejestracji na studia

Pierwszy przesłany

13 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

13 maja 2026

Pierwszy wysłany (Rzeczywisty)

19 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

24 sierpnia 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

21 sierpnia 2026

Ostatnia weryfikacja

1 sierpnia 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 2025-1138

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

produkt wyprodukowany i wyeksportowany z USA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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