Combination Chemotherapy in Treating Women With Stage II or Stage III Breast Cancer
Epirubicin Plus Paclitaxel Versus Cyclophosphamide, Epirubicin and 5-Fluorouracil as Adjuvant Treatment of Node Positive Breast Cancer Patients: A Controlled Randomized Phase III Study
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of chemotherapy is more effective for breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of combination chemotherapy in treating women who have stage II or stage III breast cancer.
調査の概要
詳細な説明
OBJECTIVES: I. Compare overall survival and disease free survival after adjuvant chemotherapy with epirubicin plus paclitaxel versus cyclophosphamide, epirubicin, and fluorouracil in women with stage IIA, IIB, or III breast cancer. II. Compare quality of life in these women with these treatment regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms within 35 days of surgery. Arm I: Patients receive epirubicin IV followed by paclitaxel IV over 3 hours on day 1. Treatment repeats every 21 days for 4 courses. Arm II: Patients receive cyclophosphamide IV, epirubicin IV, and fluorouracil IV on day 1. Treatment repeats every 21 days for 6 courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients who are postmenopausal, or premenopausal and hormone receptor positive, receive tamoxifen orally once a day for 5 years starting on day 1. Patients receive radiotherapy to residual breast after 4 courses of chemotherapy. Quality of life is assessed. Patients are followed every 3 months for 3 years, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 1,000 patients will be accrued for this study over 5 years.
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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Alba、イタリア、12051
- Ospedale San Lazzaro
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Asti、イタリア、14100
- Ospedale Civile di Asti
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Cagliari、イタリア、09124
- Ospedale Oncologico A. Businco
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Casale Monferato、イタリア、1-15033
- Santo Spirito Hospital
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Cuneo、イタリア、12100
- Ospedale Santa Croce
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Genoa、イタリア、16132
- Istituto Nazionale per la Ricerca sul Cancro
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Genoa、イタリア、16128
- Ospedale Galliera Oncologia
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La Spezia、イタリア、19100
- Ospendale S. Andrea EST
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Livorno、イタリア、57121
- Ospedale Civile di Livorno
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Mantova、イタリア、46100
- Carlo Poma Hospital
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Merate、イタリア、22055
- Azienda USSL NO 8
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Milan、イタリア、20132
- Instituto Scientifico H.S. Raffaele
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Moncalieri、イタリア、10024
- Ospedale Santa Croce
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Pavia、イタリア、27100
- I.R.C.C.S. Policlinico San Matteo
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Pisa、イタリア、56100
- Ospedale St. Santa Chiara
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San Remo、イタリア、18038
- USL NO 1
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Sassari、イタリア、07100
- Azienda U.S.L. 1 - Sassari
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Savona、イタリア、17100
- Ospedale S. Paolo
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Sestri Lev.、イタリア、16039
- Osp. Civile USL 18
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Torino、イタリア、10128
- Ospedale Mauriziano Umberto I
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Torino、イタリア、10100
- Ospedale Sant Anna
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Torino、イタリア、10125
- Ospedale Evangelico Valdese
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Torino、イタリア、10126
- OIRM - Sant Anna
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Trieste、イタリア、34100
- Ospedale Maggiore dell' Universita
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Turin、イタリア、10126
- Ospedale Molinette
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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 confirmed stage IIA, IIB, or III breast cancer treated with radical surgery (e.g., mastectomy, quadrantectomy, tumorectomy) and axillary lymph node dissection Positive axillary lymph nodes No more than 9 metastatic lymph nodes No distant metastases or local or locoregional disease No more than 5 weeks between surgery and beginning of study Hormone receptor status: Not specified
PATIENT CHARACTERISTICS: Age: 70 and under Sex: Female Menopausal status: Not specified Performance status: ECOG 0 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Transaminases, alkaline phosphatase, and gamma glutamyltransferase no greater than 1.5 times upper limit of normal Renal: Not specified Cardiovascular: No heart disease that precludes use of anthracyclines (i.e., myocardial infarction, uncontrolled angina pectoris, uncontrolled arrhythmias, or valve disease) Other: No concurrent pathology that precludes use of antineoplastic drugs No mental retardation or psychiatric disease that precludes study No other current or prior malignancy within the past 10 years except squamous or basal cell skin cancer or carcinoma in situ of the cervix Not pregnant or nursing Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: No prior antineoplastic hormonal therapy Radiotherapy: No postoperative radiotherapy except to residual breast Surgery: See Disease Characteristics
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
協力者と研究者
捜査官
- スタディチェア：Riccardo Rosso, MD、IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
研究記録日
主要日程の研究
研究開始
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
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- CDR0000067266
- INRC-GONO-MIG-5
- NCI-V99-1562
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