招募患者：Palbociclib联合来曲唑治疗亚洲女性绝经后晚期乳腺癌的III期临床研究

2015-09-09 MedSci MedSci原创

1.  试验药物简介 Palbociclib（IBRANCE®）是口服、靶向性制剂，能够选择性抑制细胞周期蛋白依赖性激酶4和6（CDK4/6），恢复细胞周期控制，阻断肿瘤细胞增殖。FDA于2013年4月授予palbociclib治疗晚期或转移性ER+/HER2-乳腺癌的突破性疗法认定。 2014年研究数据表明，与标准治疗药物曲唑（letrozole）治疗组相比，palbociclib

1. 试验药物简介

Palbociclib（IBRANCE®）是口服、靶向性制剂，能够选择性抑制细胞周期蛋白依赖性激酶4和6（CDK4/6），恢复细胞周期控制，阻断肿瘤细胞增殖。FDA于2013年4月授予palbociclib治疗晚期或转移性ER+/HER2-乳腺癌的突破性疗法认定。

2014年研究数据表明，与标准治疗药物曲唑（letrozole）治疗组相比，palbociclib+letrozole联合用药组疾病无进展生存期（PFS）取得了统计学意义的显著延长（20.2个月vs 10.2个月，p=0.0004），达到了研究的主要终点。

2. 试验目的

旨在证明在既往未接受过任何针对晚期疾病的全身性抗癌治疗的ER（+）/HER2（-）亚洲绝经后晚期乳腺癌（ABC）妇女中，Palbociclib联合来曲唑比较安慰剂联合来曲唑能够显著延长无进展生存期（PFS）。

3. 试验设计

试验分类：安全性和有效性

试验分期： III期

设计类型：平行分组（试验组：Palbociclib+来曲唑，对照组：来曲唑）

随机化：随机化

盲法：双盲

试验范围：国际多中心试验

入组人数：国际330人，其中中国264

4. 入选标准

1 确诊乳腺腺癌的成年亚洲女性（年龄18-70岁），有证据显示局部病灶复发或转移性疾病，不适合以治愈为目的的手术切除或放射治疗，且无化疗临床指征。

2 根据当地实验室结果在组织学或细胞学上证实雌激素受体阳性（ER+）乳腺癌的诊断。

3 既往未接受过任何全身性抗癌治疗的局部病灶复发或转移性ER+疾病。

4 绝经状态定义为：既往进行双侧卵巢切除术，或连续至少12个月常规月经自发性停止且无其他病理或生理原因；及对于绝经后妇女其血浆中促卵泡生成激素（FSH）在实验室参考范围之内。

5 RECIST V.1.1 中定义的可测量疾病或仅骨病。

6 东部肿瘤协作组（ECOG）体力状况（PS）0-1

7 充足的器官和骨髓功能

5. 排除标准

1 根据当地实验室利用申办者批准的分析方法的结果，通过FISH（定义为HER2/CEP17比值≥2）或显色原位杂交（CISH，按生产商的试剂盒说明进行定义）记录erbB-2基因扩增或IHC（定义为IHC3+，或有FISH或CISH确认的IHC2+）记录HER 2过度表达定义的HER2阳性肿瘤。

2 疾病晚期、出现症状、内脏扩散、在短期内有危及生命危险并发症的患者（包括有大量无法控制的溢出物的患者[胸腔、心包、腹腔]、肺淋巴管炎及超过50％的肝脏受累）。

3 已知活动的、无法控制的或有症状的中枢神经系统转移、癌性脑膜炎或临床症状提示的软脑膜疾病、脑水肿和/或肿瘤进展性生长。有中枢神经系统转移或脊髓压迫病史的患者，如已接受明确局部治疗（如放射治疗，立体定向手术治疗）且临床上稳定，在随机化前停止抗惊厥药和类固醇至少4周，则有资格入组研究。

4 既往使用非甾体芳香化酶抑制剂（即，阿那曲唑或来曲唑）新辅助治疗或辅助治疗，治疗时或治疗完成12个月内疾病复发。

5 既往采用任何CDK4/6抑制剂的治疗。

6 随机分组前2周内进行大手术、化疗、放射治疗、任何研究药物或其他抗癌治疗。既往接受对≥25%的骨髓放射治疗的患者（不管是何时接受的）不合格。

7 随机化前3年内，任何其他恶性肿瘤的诊断，经充分治疗的基底细胞或鳞状。

6. 医院和研究者信息

序号	机构名称	主要研究者	国家	省（州）	城市
1	中国医学科学院肿瘤研究所肿瘤医院	徐兵河	中国	北京	北京
2	福建医科大学附属协和医院	侯培锋	中国	福建	福州
3	吉林省肿瘤医院	程颖	中国	吉林	长春
4	浙江省肿瘤医院	王晓稼	中国	浙江	杭州
5	浙江大学医学院附属第一医院	沈朋	中国	浙江	杭州
6	上海交通大学医学院附属瑞金医院	沈坤炜	中国	上海	上海
7	湖北省肿瘤医院	吴新红	中国	湖北	武汉
8	中南大学湘雅二医院	胡春宏	中国	湖南	长沙
9	北京肿瘤医院	李惠平	中国	北京	北京
10	解放军第307医院	江泽飞	中国	北京	北京
11	河北医科大学第四医院	耿翠芝	中国	河北	石家庄
12	安徽医科大学第一附属医院	潘跃银	中国	安徽	合肥
13	江苏省人民医院	殷咏梅	中国	江苏	南京
14	江苏省肿瘤医院	冯继锋	中国	江苏	南京
15	福建省肿瘤医院	刘健	中国	福建	福州
16	四川大学华西医学院附属医院	郑鸿	中国	四川	成都
17	蚌埠医学院第一附属医院	吴穷	中国	安徽	蚌埠
18	复旦大学附属肿瘤医院	胡夕春	中国	上海	上海
19	湖南省肿瘤医院	欧阳取长	中国	湖南	长沙
20	哈尔滨医科大学附属肿瘤医院(黑江省肿瘤医院)	张清媛	中国	黑龙江	哈尔滨
21	中国医科大学第一医院	刘云鹏	中国	辽宁	沈阳
22	辽宁省肿瘤医院	孙涛	中国	辽宁	沈阳
23	吉林大学第一医院	李薇	中国	吉林	长春
24	大连医科大学附属第二医院	张阳	中国	辽宁	大连
25	河南省肿瘤医院	崔树德	中国	河南	郑州
26	中山大学附属肿瘤医院	王树森	中国	广东	广州
27	天津市肿瘤医院	佟仲生	中国	天津	天津
28	广东省人民医院	廖宁	中国	广东	广州
29	四川省肿瘤医院	李卉	中国	四川	成都
30	北京大学第三医院	王墨培	中国	北京	北京
31	第三军医大学新桥医院	朱波	中国	重庆	重庆
32	中国人民解放军总医院解放军医学院（解放军301医院）	杨俊兰	中国	北京	北京
33	云南省肿瘤医院	邹天宁	中国	云南	昆明
34	北京大学人民医院	王殊	中国	北京	北京
35	浙江大学医学院附属邵逸夫医院	潘宏铭	中国	浙江	杭州

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2016-08-05 医生2402

#I期临床#

74 0
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2016-02-20 huiwelcome

#II期临床研究#

73 0
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2016-07-01 juliusluan78

#III#

72 0
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2015-12-18 tastas

#III期临床研究#

85 0
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2015-09-11 yeye5224612

#绝经#

101 0
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2015-09-11 siiner

#来曲唑#

95 0
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2015-09-11 ysjykql

#palbociclib#

70 0
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2015-09-11 guihongzh

#II期临床#

65 0
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2015-09-11 ms1260584454294838

#招募#

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