Trastuzumab in Treating Women With HER2-Positive Early Breast Cancer
Persephone: Duration of Trastuzumab With Chemotherapy in Women With Early Stage Breast Cancer: Six Months Versus Twelve
RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known which regimen of trastuzumab is more effective in treating early breast cancer.
PURPOSE: This randomized phase III trial is comparing two trastuzumab regimens to see how well they work in treating women with HER2-positive early breast cancer.
調査の概要
詳細な説明
OBJECTIVES:
Primary
- Determine disease-free survival of women with HER2-positive early breast cancer treated with neoadjuvant or adjuvant trastuzumab (Herceptin®) for 6 months versus 12 months.
Secondary
- Determine the overall survival of patients treated with these regimens.
- Determine the expected incremental cost effectiveness (cost per quality adjusted life year gained) for 6 months versus 12 months trastuzumab.
- Determine cardiac function as assessed by left ventricular ejection fraction every 3 months during treatment.
- Analyze the predictive factors for development of cardiac damage.
OUTLINE: This is a multicenter study. Patients are stratified according to estrogen receptor status (negative vs positive); chemotherapy timing (adjuvant vs neoadjuvant); chemotherapy type (anthracycline based [no taxane] vs taxane and anthracyclines vs taxane-based [no anthracyclines]); and trastuzumab (Herceptin®) timing (concurrently vs sequentially [with respect to chemotherapy]). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive trastuzumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 12 months in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive trastuzumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 6 months in the absence of disease progression or unacceptable toxicity.
All patients also receive standard chemotherapy regimens as per local institutional protocols either concurrently with or sequentially to trastuzumab.
Patients complete quality of life questionnaires using the EuroQoL-5D (EQ-5D) at baseline and periodically during study treatment. Patients also complete a diary on out-of-pocket expenses associated with their condition (i.e., travel expenses, over-the-counter medicines and supplements, complementary therapies not funded by NHS, home help, and time away from work) for cost-effective analysis.
After completion of study therapy, patients are followed every 3 months for 1 year, then every 6 months for 1 year, and annually thereafter.
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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England
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Cambridge、England、イギリス、CB2 2QQ
- 募集
- Addenbrooke's Hospital
-
コンタクト：
- Helena Earl, MBBS, PhD, FRCP
- 電話番号：44-1223-336-800
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Carlisle、England、イギリス、CA2 7HY
- 募集
- Cumberland Infirmary
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コンタクト：
- Contact Person
- 電話番号：44-1228-523-444
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Derby、England、イギリス、DE1 2QY
- 募集
- Derbyshire Royal Infirmary
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コンタクト：
- Contact Person
- 電話番号：44-1332-347-141 ext. 2407
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Eastbourne、England、イギリス、BN21 2UD
- 募集
- Eastbourne District General Hospital
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コンタクト：
- Contact Person
- 電話番号：44-1323-417-400
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Luton、England、イギリス、LU4 0DZ
- 募集
- Luton and Dunstable Hospital
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コンタクト：
- Contact Person
- 電話番号：44-845-127-0127
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Merseyside、England、イギリス、CH63 4JY
- 募集
- Clatterbridge Centre for Oncology
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コンタクト：
- Contact Person
- 電話番号：44-151-334-1155
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Middlesbrough、England、イギリス、TS4 3BW
- 募集
- James Cook University Hospital
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コンタクト：
- Contact Person
- 電話番号：44-1642-850-850
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Northwood、England、イギリス、HA6 2RN
- 募集
- Mount Vernon Cancer Centre at Mount Vernon Hospital
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コンタクト：
- Contact Person
- 電話番号：44-1923-826-111
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Peterborough、England、イギリス、PE3 6DA
- 募集
- Peterborough Hospitals Trust
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コンタクト：
- Contact Person
- 電話番号：44-1733-874-510
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Wolverhampton、England、イギリス、WV10 0QP
- 募集
- New Cross Hospital
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コンタクト：
- Contact Person
- 電話番号：44-190-230-7999
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Scotland
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Aberdeen、Scotland、イギリス、AB25 2ZN
- 募集
- Aberdeen Royal Infirmary
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コンタクト：
- Contact Person
- 電話番号：44-84-5456-6000
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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 invasive breast cancer
- No evidence of metastatic disease
- Overexpression of HER2 receptor defined as 3+ or 2+ HER2 positivity measured by fluorescent in situ hybridization (FISH) gene amplification
Indication for chemotherapy based on the following clinical and histopathological features:
Receiving or scheduled to receive neoadjuvant chemotherapy
- Time between diagnosis biopsy and start date of chemotherapy should be less than 1 month
Receiving or scheduled to receive adjuvant chemotherapy
- Completely resected disease, with negative surgical margins (apart from deep margin if full thickness resection)
- Marginally resected disease and/or positive sentinel nodes allowed provided patients undergo completion of surgery (breast and/or axillary clearance) after chemotherapy
- Hormone receptor status known
PATIENT CHARACTERISTICS:
- Menopausal status not specified
- ECOG performance status 0-1
- Adequate bone marrow, hepatic, and renal function
- LVEF normal by ECHO or MUGA
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No clinically significant cardiac abnormalities
- No myocardial infarction within the past 6 months
- No uncontrolled or malignant hypertension
- No history of atrioventricular arrhythmia and/or congestive heart failure (even under medical control), or active second or third degree cardiac block
- No history of allergy to drugs containing polysorbate 20 and the excipient polysorbate 80 (TWEEN 80®) or history of allergy to mouse proteins
- No co-morbidity significantly adding to risks associated with cytotoxic chemotherapy (i.e., severe chronic obstructive pulmonary disease or poorly controlled diabetes)
No prior diagnosis of malignancy unless managed by surgical treatment only and disease-free for 10 years
- Prior basal cell carcinoma, cervical carcinoma in situ, or ductal carcinoma in situ of the breast allowed if treated by surgery only
- No concomitant medical or psychiatric problems that might preclude completion of treatment or follow-up
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior chemotherapy or radiotherapy
- Concurrent radiotherapy allowed
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
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：Arm I
Patients receive trastuzumab IV over 30-90 minutes on day 1.
Treatment repeats every 3 weeks for up to 12 months in the absence of disease progression or unacceptable toxicity.
All patients also receive standard chemotherapy regimens as per local institutional protocols either concurrently with or sequentially to trastuzumab.
|
与えられた IV
per the local institutional protocols either concurrently with or sequentially to trastuzumab
|
|
実験的：Arm II
Patients receive trastuzumab IV over 30-90 minutes on day 1.
Treatment repeats every 3 weeks for up to 6 months in the absence of disease progression or unacceptable toxicity.
All patients also receive standard chemotherapy regimens as per local institutional protocols either concurrently with or sequentially to trastuzumab.
|
与えられた IV
per the local institutional protocols either concurrently with or sequentially to trastuzumab
|
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 |
|---|
|
無病生存
|
二次結果の測定
結果測定 |
|---|
|
全生存
|
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Cost effectiveness and quality of life
|
|
Cardiac function and analysis of predictive factors for development of cardiac damage
|
協力者と研究者
スポンサー
出版物と役立つリンク
一般刊行物
- Earl H, Hiller L, Vallier AL, Loi S, McAdam K, Hughes-Davies L, Rea D, Howe D, Raynes K, Higgins HB, Wilcox M, Plummer C, Mahler-Araujo B, Provenzano E, Chhabra A, Gasson S, Balmer C, Abraham JE, Caldas C, Hall P, Shinkins B, McCabe C, Hulme C, Miles D, Wardley AM, Cameron DA, Dunn JA. Six versus 12 months' adjuvant trastuzumab in patients with HER2-positive early breast cancer: the PERSEPHONE non-inferiority RCT. Health Technol Assess. 2020 Aug;24(40):1-190. doi: 10.3310/hta24400.
- Earl HM, Hiller L, Vallier AL, Loi S, McAdam K, Hughes-Davies L, Harnett AN, Ah-See ML, Simcock R, Rea D, Raj S, Woodings P, Harries M, Howe D, Raynes K, Higgins HB, Wilcox M, Plummer C, Mansi J, Gounaris I, Mahler-Araujo B, Provenzano E, Chhabra A, Abraham JE, Caldas C, Hall PS, McCabe C, Hulme C, Miles D, Wardley AM, Cameron DA, Dunn JA; PERSEPHONE Steering Committee and Trial Investigators. 6 versus 12 months of adjuvant trastuzumab for HER2-positive early breast cancer (PERSEPHONE): 4-year disease-free survival results of a randomised phase 3 non-inferiority trial. Lancet. 2019 Jun 29;393(10191):2599-2612. doi: 10.1016/S0140-6736(19)30650-6. Epub 2019 Jun 6.
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
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
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