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卫材启动抗癌药Halaven III期研究

来源:生物谷 2014-03-04 18:05

2014年3月4日讯 /生物谷BIOON/ --卫材(Eisai)3月3日宣布,已启动一项大规模、随机、多中心III期临床试验,将调查抗癌药物Halaven(eribulin mesylate)作为一线或二线药物,用于HER2阴性、局部复发或转移性乳腺癌(MBC)治疗时,相对于标准的每周一次紫杉醇(paclitaxel)的疗效、安全性和耐受性。该项研究的主要终点是总生存期(OS),次要终点包括无进展生存期(PFS)和肿瘤客观缓解率。

该项研究所招募的患者为,既往已接受不超过1种化疗方案的HER2阴性乳腺癌患者。研究中,患者将随机平均分配(1:1)接受Halaven或标准的每周一次的紫杉醇治疗。

Halaven是一种合成的大田软海绵素(halichondrin B)类似物,已获全球近40个国家批准,用于既往已接受至少2种化疗药物(包括蒽环类和紫杉类药物)治疗的局部晚期或转移性乳腺癌患者的治疗。

Halichondrin B是一种从生长在日本沿海的黑色海绵上发现的物质,能够有效治愈肿瘤。(生物谷Bioon.com)

英文原文:Eisai starts Phase III breast cancer trial of eribulin mesylate versus paclitaxel

Published 03 March 2014

Eisai has started a large, randomized Phase III trial to compare the efficacy, safety and tolerability of eribulin mesylate injection to standard weekly paclitaxel as a first or second- line treatment for HER2-negative locally recurrent or metastatic breast cancer (MBC).

Recruitment is currently in process for the multicenter trial, which is being conducted in partnership with the Academic and Community Cancer Research United (ACCRU) group.

Across the US, about 910 patients are expected to be enrolled in the trial, which involves an investigational use of eribulin mesylate.

The trial is intended for patients with HER2-negative breast cancer who have received no more than one prior chemotherapy regimen once their breast cancer has spread.

The company said that eligible patients will be randomly selected with equal allocation (1:1) to receive treatment for their cancer with either eribulin mesylate or standard weekly paclitaxel, within strata defined by prior adjuvant taxanes, hormone receptor status (ER/PgR), and line of therapy.

Primary endpoint of the trial is overall survival, while secondary endpoints include progression-free survival and objective tumor response rate.

In the trial, safety and tolerability of the treatment groups will also be continuously monitored.

MBC is the form of the disease that refers to the most advanced stage in which cancer cells break away from the tumor in the breast, spread to other parts of the body and continue growing.

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