Evaluation of Trastuzumab Without Chemotherapy as a Post-operative Adjuvant Therapy in HER2-positive Elderly Breast Cancer Patients: Randomized Controlled Trial [RESPECT (N-SAS BC07)]
Evaluation of Trastuzumab Without Chemotherapy as a Post-operative Adjuvant Therapy in HER2-positive Elderly Breast Cancer Patients: Randomized Controlled Trial [RESPECT (N-SAS BC07)]
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DOI：
10.1093/jjco/hyr011
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发表时间：
2011-05-01
影响因子：
2.4
通讯作者：
Ohashi, Yasuo
中科院分区：
文献类型：
--
作者：
Sawaki, Masataka;Tokudome, Nahomi;Ohashi, Yasuo
目的：本试验旨在探讨曲妥珠单抗与曲妥珠单抗联合化疗治疗70岁以上人表皮生长因子受体2型阳性乳腺癌的疗效。方法：纳入标准如下：组织学诊断为浸润性乳腺癌并接受手术治疗；I、IIA、IIB或IIIA/M0期；基线左心室射血分数为55%。患者随机接受曲妥珠单抗(负荷量8毫克/公斤，每3周6毫克/公斤，为期一年)加从方案中指定的方案中选择的化疗或曲妥珠单抗单一治疗。主要终点是无病生存。次要终点是总体生存期、无复发生存期、安全性、与健康相关的生活质量、综合老年评估和成本效益。在4年的招募期间计划招募300名患者。结论：我们在此报告研究的概念。
Objective: This trial is conducted to investigate the benefit of trastuzumab monotherapy compared with a combination therapy of trastuzumab and chemotherapy in women over 70 years with human epidermal growth factor receptor type-2-positive primary breast cancer.Methods: Inclusion criteria are the following: histologically diagnosed as invasive breast cancer and received curative operation for primary breast cancer; Stage I, IIA, IIB or IIIA/M0; and baseline left ventricular ejection fraction is >= 55%. Patients are randomized to receive either trastuzumab (8 mg/kg loading dose, 6 mg/kg every 3 weeks for 1 year) plus chemotherapy selected from regimens specified on the protocol or trastuzumab monotherapy. The primary endpoint is disease-free survival. Secondary endpoints are overall survival, relapse-free survival, safety, health-related quality of life, comprehensive geriatric assessment and cost effectiveness.Results: Patients recruitment has been commenced in October 2009. Enrollment of 300 patients is planned during the 4-year recruitment period.Conclusions: We hereby report the study concept.