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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

2026年8月21日 更新者：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.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

100

段階

  • フェーズ2
  • フェーズ 1

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前：Oana Danciu, MD
  • 電話番号：(312) 355-1625
  • メール：ocdanciu@uic.edu

研究連絡先のバックアップ

  • 名前：Michelle Karan
  • 電話番号：(224) 563-7137
  • メール：makaran2@uic.edu

研究場所

  • アメリカ
    • Illinois
      • Chicago、Illinois、アメリカ、60612
        • University of Illinois at Chicago
        • 主任研究者：
          • Oana Danciu, MD
        • コンタクト：
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ：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.
薬：Aromatase Inhibitors
An aromatase inhibitor will be given at a duration, frequency, and dose per standard of care.
他の名前：
  • エキセメスタン
  • レトロゾール
  • アナストロゾール
薬：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.
他の名前：
  • ロイプロリド
  • ゴセレリン
アクティブコンパレータ：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.
薬：Aromatase Inhibitors
An aromatase inhibitor will be given at a duration, frequency, and dose per standard of care.
他の名前：
  • エキセメスタン
  • レトロゾール
  • アナストロゾール
実験的：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.
薬：Aromatase Inhibitors
An aromatase inhibitor will be given at a duration, frequency, and dose per standard of care.
他の名前：
  • エキセメスタン
  • レトロゾール
  • アナストロゾール
薬：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.
他の名前：
  • ロイプロリド
  • ゴセレリン
薬：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
他の名前：
  • ウェルブトリン
  • ザイバン
実験的：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.
薬：Aromatase Inhibitors
An aromatase inhibitor will be given at a duration, frequency, and dose per standard of care.
他の名前：
  • エキセメスタン
  • レトロゾール
  • アナストロゾール
薬：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
他の名前：
  • ウェルブトリン
  • ザイバン

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Tolerance of study drugs in patients with early stage breast cancer and Hypoactive Sexual Desire Disorder
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Disease free-survival in patients with early stage breast cancer and Hypoactive Sexual Desire Disorder
時間枠：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
時間枠：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
時間枠：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
時間枠：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

その他の成果指標

結果測定
メジャーの説明
時間枠
Prevalence and response to treatment of Hypoactive Sexual Desire Disorder in patients with early stage breast cancer across different racial groups
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

University of Illinois at Chicago

捜査官

  • 主任研究者：Oana Danciu, MD、University of Illinois at Chicago

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年9月1日

一次修了 (推定)

2028年9月1日

研究の完了 (推定)

2031年9月1日

試験登録日

最初に提出

2026年5月13日

QC基準を満たした最初の提出物

2026年5月13日

最初の投稿 (実際)

2026年5月19日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月24日

QC基準を満たした最後の更新が送信されました

2026年8月21日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • 2025-1138

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米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

いいえ

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