Triptorelin in Preventing Early Menopause in Premenopausal Women Who Are Receiving Chemotherapy for Stage I, Stage II, or Stage III Breast Cancer That Has Been Removed By Surgery
Prevention of Chemotherapy-induced Menopause by Temporary Ovarian Suppression With Triptorelin Vs. Control in Young Breast Cancer Patients. A Randomized Phase III Multicenter Study [PROMISE]
RATIONALE: Chemotherapy may cause early menopause in premenopausal women. Triptorelin may prevent this from happening.
PURPOSE: This randomized phase III trial is studying triptorelin to see how well it works in preventing early menopause in premenopausal women who are receiving chemotherapy for stage I, stage II, or stage III breast cancer that has been removed by surgery.
調査の概要
状態
条件
詳細な説明
OBJECTIVES:
Primary
- Evaluate the incidence of chemotherapy-induced early menopause in premenopausal women undergoing adjuvant chemotherapy in combination with vs without triptorelin for previously resected stage I-III breast cancer.
Secondary
- Compare the toxicity of adjuvant chemotherapy and triptorelin vs adjuvant chemotherapy alone.
OUTLINE: This is a prospective, open-label, multicenter, randomized study. Patients are randomized to 1 of 2 treatment arms.
- Arm I (adjuvant chemotherapy alone): Patients receive adjuvant chemotherapy alone.
- Arm II (adjuvant chemotherapy and triptorelin): Patients receive adjuvant chemotherapy and triptorelin intramuscularly 1 week before and then every 4 weeks for the duration of chemotherapy. The last dose of triptorelin is given before the last course of chemotherapy.
Patients with hormone-sensitive tumors who resume ovarian function after stopping chemotherapy and triptorelin restart triptorelin until ovarian function is suppressed for 2 years.
Patients undergo menopausal status assessment, using follicle-stimulating hormone, luteinizing hormone, and estradiol as biochemical markers, at baseline and 3, 6, 9, and 12 months after the last course of chemotherapy.
After completion of study treatment, patients are followed at 3, 6, 9, and 12 months.
PROJECTED ACCRUAL: A total of 280 patients will be accrued for this study.
研究の種類
入学 (予想される)
段階
- フェーズ 3
連絡先と場所
研究場所
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Castelfranco - TV、イタリア、31033
- Ospedale Civile
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Como、イタリア、22100
- Ospedale Sant Anna
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Cuneo、イタリア、12100
- Ospedale Santa Croce
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Florence、イタリア、50011
- Azienda Ospedaliera di Firenze
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Genoa、イタリア、16132
- Istituto Nazionale per la Ricerca sul Cancro
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Livorno、イタリア、57100
- Presidio Ospedaliero Di Livorno
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Mantova、イタリア、46100
- Carlo Poma Hospital
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Naples、イタリア、80131
- Federico II University Medical School
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Naples、イタリア、80131
- Seconda Universita di Napoli
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Naples、イタリア、81131
- Istituto G. Pascale
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Perugia、イタリア、06156
- Ospedale Silvestrini
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Pisa、イタリア、56126
- Ospedale Santa Chiara Pisa
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Rome、イタリア、00128
- Istituto Regina Elena
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Sassari、イタリア、07100
- Ospedale Civile ASL 1
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Sora、イタリア、03039
- Ospedale SS Trinità
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Treviglio、イタリア、24047
- Ospedale Treviglio Caravaggio
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Trieste、イタリア、34100
- Ospedale Maggiore dell' Universita
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Turin、イタリア、10126
- Università di Torino
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参加基準
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
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed breast cancer resected at time of original diagnosis
- Stage I-III disease
Candidate for 1 of the following adjuvant chemotherapy regimens:
- FEC (fluorouracil, epirubicin hydrochloride, and cyclophosphamide) every 21 or 28 days
- CMF (cyclophosphamide, methotrexate, and fluorouracil) every 28 days
- A→CMF (doxorubicin hydrochloride followed by CMF)
- EC→P (epirubicin hydrochloride and cyclophosphamide every 21 days followed by paclitaxel every 21 days)
- FEC→P (FEC every 21 days followed by paclitaxel every 21 days)
- EC→D (EC every 21 days followed by docetaxel every 21 days)
- AC (doxorubicin hydrochloride and cyclophosphamide) every 21 days
- AC→P (AC every 21 days followed by paclitaxel every 21 days)
- E→CMF (epirubicin hydrochloride followed by CMF every 28 days)
No evidence of metastases or localized or distant recurrence
- Investigation to exclude metastases required for any suspicious manifestation
- Premenopausal, defined as the presence of active menstrual cycles or normal menses within six weeks before initiation of chemotherapy
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Female
- No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or adequately treated in situ carcinoma of the cervix
- No history of noncompliance to medical regimens or patients who are considered potentially unreliable
- Not pregnant or nursing
- Negative pregnancy test
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior chemotherapy and/or radiotherapy for cancer or non-neoplastic disease
- No other concurrent hormonal therapy except for tamoxifen
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：支持療法
- 割り当て：ランダム化
- マスキング：なし（オープンラベル）
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 |
|---|
|
Chemotherapy-induced early menopause as measured by follicle-stimulating hormone, 17 beta estradiol levels, and menstrual activity resumption at 1 year following the completion of chemotherapy
|
二次結果の測定
結果測定 |
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Toxicity as measured by Common Toxicity Criteria at each chemotherapy course
|
協力者と研究者
捜査官
- スタディチェア：Lucia Del Mastro, MD、IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
出版物と役立つリンク
一般刊行物
- Del Mastro L, Boni L, Michelotti A, Gamucci T, Olmeo N, Gori S, Giordano M, Garrone O, Pronzato P, Bighin C, Levaggi A, Giraudi S, Cresti N, Magnolfi E, Scotto T, Vecchio C, Venturini M. Effect of the gonadotropin-releasing hormone analogue triptorelin on the occurrence of chemotherapy-induced early menopause in premenopausal women with breast cancer: a randomized trial. JAMA. 2011 Jul 20;306(3):269-76. doi: 10.1001/jama.2011.991.
- Lambertini M, Boni L, Michelotti A, Gamucci T, Scotto T, Gori S, Giordano M, Garrone O, Levaggi A, Poggio F, Giraudi S, Bighin C, Vecchio C, Sertoli MR, Pronzato P, Del Mastro L; GIM Study Group. Ovarian Suppression With Triptorelin During Adjuvant Breast Cancer Chemotherapy and Long-term Ovarian Function, Pregnancies, and Disease-Free Survival: A Randomized Clinical Trial. JAMA. 2015 Dec 22-29;314(24):2632-40. doi: 10.1001/jama.2015.17291.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
- 皮膚疾患
- 新生物
- 部位別新生物
- 乳房の病気
- 乳房腫瘍
- 薬の生理作用
- 薬理作用の分子機構
- 核酸合成阻害剤
- 酵素阻害剤
- 抗リウマチ剤
- 代謝拮抗薬、抗腫瘍薬
- 代謝拮抗剤
- 抗悪性腫瘍薬
- 免疫抑制剤
- 免疫学的要因
- チューブリンモジュレーター
- 抗有糸分裂剤
- 有糸分裂モジュレーター
- 抗腫瘍剤、ホルモン剤
- 抗悪性腫瘍薬、アルキル化
- アルキル化剤
- 骨髄破壊的アゴニスト
- 抗悪性腫瘍剤、ファイトジェニック
- トポイソメラーゼ II 阻害剤
- トポイソメラーゼ阻害剤
- 皮膚科用薬
- 抗生物質、抗悪性腫瘍薬
- 避妊薬、ホルモン
- 避妊薬
- 生殖制御剤
- 避妊薬、女性
- 妊娠中絶薬、非ステロイド系
- 中絶エージェント
- 葉酸拮抗薬
- 黄体分解剤
- ドセタキセル
- シクロホスファミド
- パクリタキセル
- フルオロウラシル
- エピルビシン
- ドキソルビシン
- リポソームドキソルビシン
- メトトレキサート
- トリプトレリン パモエート
その他の研究ID番号
- GIM-6
- CDR0000468839 (レジストリ識別子：PDQ (Physician Data Query))
- GIM-PROMISE
- EU-20606
- GIM-5104
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。