Multicentric, Randomized Phase III Trial of Two Different Adjuvant Chemotherapy Regimens plus Three Versus Twelve Months of Trastuzumab in Patients with HER2-Positive Breast Cancer (Short-HER Trial; NCT00629278)

被引：37

作者：

Guarneri, Valentina ^{[1
]}

Frassoldati, Antonio ^{[1
]}

Bruzzi, Paolo

D'Amico, Roberto ^{[1
]}

Belfiglio, Maurizio

Molino, Annamaria ^{[3
]}

Bertetto, Oscar ^{[4
]}

Cascinu, Stefano ^{[5
]}

Cognetti, Francesco ^{[6
]}

Di Leo, Angelo

Pronzato, Paolo ^{[2
]}

Crino, Lucio ^{[7
]}

Agostara, Biagio

Conte, PierFranco ^{[1
]}

机构：

[1] Univ Hosp, Dept Hematol & Oncol, Div Med Oncol, I-41100 Modena, Italy

[2] Natl Inst Canc Res, Div Med Oncol, Genoa, Italy

[3] Univ Verona, Dept Med Oncol, I-37100 Verona, Italy

[4] Azienda Osped San Giovanni Battista, COES, Div Med Oncol, Turin, Italy

[5] Univ Politecn Marche, Univ Hosp, Dept Med Oncol, Ancona, Italy

[6] Regina Elena Inst Canc Res, Div Med Oncol A, Rome, Italy

[7] Osped S Maria Misericordia, Dept Med Oncol, Perugia, Italy

来源：

CLINICAL BREAST CANCER | 2008年 / 8卷 / 05期

关键词：

Adjuvant therapy; Cardiac toxicity; HER2; Trastuzumab duration;

D O I：

10.3816/CBC.2008.n.056

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Trastuzumab, a monoclonal antibody against the HER2 receptor, is currently approved as a part of adjuvant therapy for patients with HER2-overexpressing breast tumors. The Short-HER study is a phase III randomized, multicentric Italian trial aimed at testing the optimal duration of adjuvant trastuzumab. In this trial, 2005 patients with HER2-positive breast cancer will be randomized to receive the following: (arm A, long) 4 courses of anthra-cycline-based chemotherapy (doxorubicin/cyclophosphamide or epidoxorubicin/cyclophosphamide) followed by 4 courses of docetaxel or paclitaxel in combination with trastuzumab, followed by 14 additional courses of trastuzumab administered every 3 weeks (for a total of 18 3-weekly doses of trastuzumab); or (arm B, short) 3 courses of 3-weekly docetaxel in combination with weekly trastuzumab (for a total of 9 weekly doses of trastuzumab) followed by 3 courses of 5-fluorouracil/epirubicin/cyclophosphamide. The primary objective is disease- free survival.

引用

页码：453 / 456

页数：4

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