The Synergism Or Long Duration (SOLD) Study (SOLD)
A Randomized Phase III Study Comparing Trastuzumab Plus Docetaxel (HT) Followed by 5-FU, Epirubicin, and Cyclophosphamide (FEC) to the Same Regimen Followed by Single-agent Trastuzumab as Adjuvant Treatments for Early Breast Cancer
調査の概要
状態
条件
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
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Helsinki、フィンランド、00029 HUS
- Helsinki University Central Hospital, Department of Oncology
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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
Inclusion Criteria:
- Patient has provided a written informed consent prior to study-specific screening procedures, with the understanding that she has the right to withdraw from the study at any time, without prejudice.
- Woman > 18 years of age.
- Histologically confirmed invasive breast cancer.
- HER2-positive breast cancer (preferably assessed with CISH or FISH; if not available with immunohistochemistry 3+)
A high risk of breast cancer recurrence with one of the following:
- Pathological N0 with the longest invasive tumor diameter >5 mm
- Histologically confirmed regional node positive disease (pN+; nodal isolated tumor cells/cell clusters < 0.2 mm in diameter (ITP) are not counted as a metastasis)
Exclusion Criteria:
- Presence of distant metastases.
- Inflammatory breast cancer.
- pT1bN0M0 (i.e. the longest tumor diameter 6 to 10 mm, node-negative) and histological grade 1.
- Clinically significant (i.e. active) cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmia not well controlled with medication) or myocardial infarction within the last 12 months.
- Left ventricular ejection fraction less than 50% (or under the institutional normal reference range) assessed by echocardiography or isotope cardiography.
- ER, PgR and HER-2 status (via in situ hybridization or immunohistochemistry) not determined.
- Primary systemic cancer therapy (neoadjuvant chemotherapy or endocrine therapy) has been administered prior to breast surgery.
- The WHO performance status > 1.
- Pregnant or lactating women.
- Women of childbearing potential unless using a reliable and appropriate contraceptive method. Women must have been amenorrheic for at least 12 months prior to study entry to be considered postmenopausal and to have no childbearing potential. Women of childbearing potential (menstruating within 12 months of study entry), or with no hysterectomy and age < 55, must have a negative pregnancy test at baseline.
- More than 12 weeks between breast surgery and date of randomization.
- Organ allografts with immunosuppressive therapy required.
- Major surgery (except breast surgery) within 4 weeks prior to study treatment start, or lack of complete recovery from the effects of major surgery.
- Participation in any investigational drug study within 4 weeks preceding treatment start.
- Patients with a history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant precluding study participation.
- History of another malignancy within the last five years except cured basal cell carcinoma of skin or carcinoma in situ of the uterine cervix.
One or more of the following:
- Blood hemoglobin < 10.0 g/dL, neutrophils < 1.5 x 109/L, platelet count < 120 x 109/L
- Serum/plasma creatinine > 1.5 x Upper Limit of Normal (ULN)
- Serum/plasma bilirubin > ULN
- Serum/plasma ALT and/or AST > 1.5 x ULN
- Serum/plasma alkaline phosphatase > 2.5 x ULN
- Serious uncontrolled infection or other serious uncontrolled concomitant disease.
- Unwilling or unable to comply with the protocol for the duration of the study.
- History of hypersensitivity to the investigational products or to drugs with similar chemical structures.
- Pre-existing motor or sensory neurotoxicity of a severity ≥ grade 2 by CTCAE version 3, unless related to mechanical etiology.
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)
武器と介入
参加者グループ / アーム |
介入・治療 |
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アクティブコンパレータ:A
Weekly or 3-weekly trastuzumab plus 3-weekly docetaxel (3 cycles) (HT) -> 3-weekly FE75C (3 cycles) (HT x3 -> FE75C x3)
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Patients diagnosed with early breast cancer with a high risk of disease recurrence will be randomly allocated to one of the following 2 arms in a 1:1 ratio: A. Weekly or 3-weekly trastuzumab plus 3-weekly docetaxel (3 cycles) (HT) -> 3-weekly FE75C (3 cycles) (HT x3 ->FE75C x3) B. Weekly or 3-weekly trastuzumab plus 3-weekly docetaxel (3 cycles) (HT) -> 3-weekly FE75C (3 cycles) -> trastuzumab to complete 1 year (14 3-weekly infusions) (HT x3 ->FE75C x3 -> H3wkly x14) |
アクティブコンパレータ:B
Weekly or 3-weekly trastuzumab plus 3-weekly docetaxel (3 cycles) (HT) -> 3-weekly FE75C (3 cycles) -> trastuzumab to complete 1 year (14 3-weekly infusions) (HT x3 ->FE75C x3 -> H3wkly x14)
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Weekly or 3-weekly trastuzumab plus 3-weekly docetaxel (3 cycles) (HT) -> 3-weekly FE75C (3 cycles) -> trastuzumab to complete 1 year (14 3-weekly infusions) (HT x3 ->FE75C x3 -> H3wkly x14)
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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 |
時間枠 |
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Disease-free survival (DFS)
時間枠:3-10years
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3-10years
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二次結果の測定
結果測定 |
時間枠 |
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Overall survival, distant disease-free survival, cardiac event-free disease-free survival, left ventricle ejection fractions, adverse events, quality of life
時間枠:3-10years
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3-10years
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協力者と研究者
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
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
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。
乳房腫瘍の臨床試験
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