局所および局所進行性閉経前ホルモン受容体陽性乳癌患者における卵巣機能抑制（OFS）のための代替部位酢酸ゴセレリン注射の評価
MC250301、OptiOFS：局所および局所進行性閉経前乳がんにおける卵巣機能抑制（OFS）のための代替部位酢酸ゴセレリン注射に関するランダム化第II相試験
This phase II trial determines if giving goserelin acetate injections in the upper gluteal region is as effective for ovarian function suppression (OFS) as giving injections in the abdomen for ovarian function suppression (OFS) in premenopausal patients with hormone receptor positive breast cancer that has not spread to other parts of the body (localized) or that has spread to nearby tissue or lymph nodes (locally advanced). Goserelin acetate is a drug used to treat prostate cancer, relieve the symptoms of advanced breast cancer, and treat problems with the endometrium (lining of the uterus). Goserelin acetate initially causes the pituitary gland to make more luteinizing hormone (LH) and follicle-stimulating hormone (FSH), temporarily increasing testosterone levels in men and estrogen levels in women. With continued use, goserelin acetate lowers the amount of LH and FSH the pituitary gland releases, leading to a drop in testosterone levels in men and estrogen levels in women. Goserelin acetate may stop the growth of cancer cells that need testosterone or estrogen to grow. It is a type of hormone therapy called a luteinizing hormone-releasing hormone (LHRH) agonist. Giving goserelin acetate injections in the upper gluteal region may be as effective for OFS as giving injections in the abdomen for OFS in premenopausal patients with localized or locally advanced hormone receptor positive breast cancer.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- フェーズ2
連絡先と場所
研究連絡先
研究連絡先
- 名前：Clinical Trials Referral Office
- 電話番号：855-776-0015
- メール：mayocliniccancerstudies@mayo.edu
研究連絡先のバックアップ
- 名前：Cancer Center Clinical Trials
- 電話番号：507-293-6386
研究場所
-
-
Minnesota
-
Rochester、Minnesota、アメリカ、55905
- 募集
- Mayo Clinic in Rochester
-
コンタクト：
- Clinical Trials Referral Office
- 電話番号：855-776-0015
- メール：mayocliniccancerstudies@mayo.edu
-
コンタクト：
- Cancer Center Clinical Trials
- 電話番号：507-293-6386
-
主任研究者：
- Karthik V. Giridhar, MD
-
-
参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
-
REGISTRATION (STEP 1): Age ≥ 18 years and ˂ 50 years
-
REGISTRATION (STEP 1): Have histologically or cytologically confirmed, localized or locally advanced hormone positive breast cancer stage I-III (defined as ER Immunohistochemistry (IHC) > 1%] having completed curative intent therapy and clinically in remission
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REGISTRATION (STEP 1): Currently receiving ovarian function suppression (OFS) with use of goserelin on a monthly basis in the abdomen and either aromatase inhibitor or tamoxifen for at least 6 months prior to study enrollment for treatment of hormone receptor positive breast cancer with plan to continue medical OFS for at least the next 12 months
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REGISTRATION (STEP 1): Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
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REGISTRATION (STEP 1): Provide written informed consent
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REGISTRATION (STEP 1): Ability to complete questionnaire(s) by themselves or with assistance
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REGISTRATION (STEP 1): Willingness to provide mandatory blood specimens for correlative research
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REGISTRATION (STEP 1): Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
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REGISTRATION (STEP 1): Negative serum pregnancy test =< 14 days prior to registration, and a negative urine pregnancy test =< 7 days prior to randomization
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REGISTRATION (STEP 1): Sexually active patients and their partners must use an effective method of contraception associated with a low failure rate prior to study entry and for the duration of study participation and for at least 3 months after the last dose of study drug.
- Note: The following are considered effective contraceptives: oral contraceptive pill; condom plus spermicide; diaphragm plus spermicide; patient or partner surgically sterile; patient or partner more than 12 months postmenopausal; or injectable or implantable agent/device. Male patients should refrain from sperm donation and female patients should refrain from breastfeeding throughout this period
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RANDOMIZATION (STEP 2): Completion of the lead-in treatment of 6 cycles of ovarian function suppression (OFS) with use of goserelin, with estradiol E2 value of ˂ 20 pg/mL and no back to back E2 levels > 10 pg/mL after cycle 6 blood draw
Exclusion Criteria:
- REGISTRATION (STEP 1): Any of the following prior therapies: Chemotherapy =< 6 months prior to registration. NOTE: concurrent receipt of human epidermal growth factor receptor 2 (HER2) directed antibodies or antibody-drug conjugates, endocrine therapy, or cyclin-dependent kinase (CDK) 4/6 inhibitor is permitted
- REGISTRATION (STEP 1): Receiving any estrogen or progestin containing medications, including topical estrogens
- REGISTRATION (STEP 1): Planning to temporarily or permanently discontinue medical OFS in the next 12 months
研究計画
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）
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：Arm I (Goserelin acetate)
Patients receive goserelin acetate SC in the abdomen on day 1 of each cycle. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients receive goserelin acetate SC in the upper gluteal region on day 1 of each cycle. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection on study. |
Undergo blood sample collection
他の名前：
Ancillary studies Given SC
他の名前：
|
|
実験的：Arm II (Goserelin acetate)
Patients receive goserelin acetate SC in the abdomen on day 1 of each cycle. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients receive goserelin acetate SC in the upper gluteal region on day 1 of each cycle. Cycles repeat every 84 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection on study. |
Undergo blood sample collection
他の名前：
Ancillary studies Given SC
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Ovarian function suppression (OFS) maintenance
時間枠：6 months
|
Failure to maintain OFS (yes; no) is defined as estradiol ≥ 10 pg/mL on two separate occasions. Will be based on calculating the within-arm sample proportion of patients for whom upper gluteal region administration of goserelin for 6 months failed to maintain OFS after switching from monthly abdominal administration of goserelin and corresponding upper bound of the one-sided 97.5% confidence interval (CI). Provided that the upper bound of the one sided 97.5% CI excludes 10%, the primary aim for that arm will have been met. |
6 months
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Provider-reported adverse events (AEs)
時間枠：Up to 1 year
|
Will be scored using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. The maximum grade for each type of AE will be recorded for each patient and frequency tables will be reviewed to determine overall patterns. |
Up to 1 year
|
|
Injection site preference
時間枠：Up to 1 year
|
Will be measured by single-question site preference survey (abdomen, upper gluteal region, no preference or unsure). |
Up to 1 year
|
その他の成果指標
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Patient Reported Outcomes and Quality of Life
時間枠：Baseline, 3 months, 6 months, 9 months, 12 months
|
Assessed by a study-specific questionnaire related to injection pain and post-injection symptoms such as bruising, swelling, or skin irritation. The questionnaire consists of 7 questions, one yes/no question; 5 questions answered on an 11-point scale from 0 (none) to 10 (most you can imagine); and one overall quality of life question answered on a scale of 0 (as bas as it can be) to 10 (as good as it can be). Higher scores for symptom questions indicate more sever symptoms. Any change from baseline will be summarized descriptively. |
Baseline, 3 months, 6 months, 9 months, 12 months
|
協力者と研究者
捜査官
捜査官
- 主任研究者：Karthik V. Giridhar, MD、Mayo Clinic
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
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
その他の研究ID番号
- MC250301
- MC250301 (その他の識別子：Mayo Clinic)
- NCI-2026-00968 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
- 25-006670 (その他の識別子：Mayo Clinic Institutional Review Board)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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