乳腺癌治疗取得重大突破||乳腺癌临床试验招募

2017-11-06 MedSci MedSci原创

乳腺癌是发生在乳腺腺上皮组织的恶性肿瘤。全球乳腺癌发病率自20世纪70年代末开始一直呈上升趋势,已成为当前社会的重大公共卫生问题。在我国,乳腺癌的发病率也逐年上升,每年有近20万女性被诊断出乳腺癌,当前乳腺癌已成为我国女性肿瘤第一位,并且我国乳腺癌患者死亡率相比国外患者相对较高,治愈率较低。因此迫切需要研发新的药物和治疗手段以提高我国乳腺癌患者的治愈率和降低死亡率。目前在我国多家大型医院正在开展一

乳腺癌是发生在乳腺腺上皮组织的恶性肿瘤。全球乳腺癌发病率自20世纪70年代末开始一直呈上升趋势,已成为当前社会的重大公共卫生问题。在我国,乳腺癌的发病率也逐年上升,每年有近20万女性被诊断出乳腺癌,当前乳腺癌已成为我国女性肿瘤第一位,并且我国乳腺癌患者死亡率相比国外患者相对较高,治愈率较低。因此迫切需要研发新的药物和治疗手段以提高我国乳腺癌患者的治愈率和降低死亡率。

目前在我国多家大型医院正在开展一项比较HLX02与欧洲(EU)来源赫赛汀+多西他赛治疗乳腺癌的疗效,以证明两者之间的生物学等效性的的III期临床研究,如您是乳腺癌患者,愿意参与到药物治疗方法的探索并满足下列条件,欢迎您的随时推荐患者参与到临床试验。

诚邀您参与项目:


研究设计:

一项比较曲妥珠单抗生物仿制药HLX02与欧洲-来源赫赛汀®治疗既往未经治疗的HER2-过度表达转移性乳腺癌患者的疗效并评价二者的安全性和免疫原性的双盲、随机化、多中心、III期临床研究,全球共约83家研究中心,按1:1分组。

下面的流程图可以帮助您理解研究过程:


患者入选标准:

1 自愿参与研究并签署了书面知情同意书的患者;
2 签署知情同意书时年龄≥18岁的女性;
3 组织学或细胞学确认乳腺腺癌;
4 无法实施根治手术的局部复发性疾病或转移性疾病,存在使用含紫杉醇治疗方案指征;
5 可获得采集自原发性肿瘤的福尔马林固定石蜡包埋(FFPE)组织块,根据FISH放大率2.2或IHC得分3+这一测试结果,中心实验室确认HER2过度表达,还可确认激素(ER/PgR)状态(由当地或中心实验室进行);如果无法获得以上组织块,应要求提供新鲜活检标本;
6 既往未针对转移性疾病进行过全身性化疗或靶向药物治疗,允许既往针对转移性疾病实施一次激素治疗,激素治疗需在随机分配前至少4周停止;
7 既往实施的(新)辅助治疗(不包括拉帕替尼或非赫赛汀的HER2靶向治疗药物)需在随机分配前至少12个月完成,但激素治疗只需在随机分配前至少4周停止;
8 可测量疾病;不接受仅骨转移疾病;
9 美国东部肿瘤协作组(ECOG)体力状况(PS) ≤1;

诚挚邀请各位医生推荐患者,造福患者改善患者医疗环境。需要您和我共同的努力。报名请点击图片

项目咨询:021 6408 5875*8057  QQ:931366229


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    2017-11-23 jihuaijun1112

    学习学习学习

    0

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