A Study of Trastuzumab Emtansine Versus Capecitabine + Lapatinib in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer (EMILIA)
2016年9月10日 更新者：Hoffmann-La Roche
A Randomized, Multicenter, Phase III Open-label Study of the Efficacy and Safety of Trastuzumab MCC-DM1 vs. Capecitabine + Lapatinib in Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Trastuzumab-Based Therapy
This is a Phase III, randomized, multicenter, international, 2-arm, open-label clinical trial designed to compare the safety and efficacy of trastuzumab emtansine (T-DM1) with that of capecitabine + lapatinib in participants with human epidermal growth factor receptor 2 (HER2)-positive locally advanced or metastatic breast cancer.
Participants will be treated until disease progression (PD), unmanageable toxicity, or study termination.
Once disease progression is reported, all participants will be followed for survival every 3 months until death, loss to follow-up, withdrawal of consent, or study termination.
研究概览
研究类型
介入性
注册 (实际的)
991
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Herlev、丹麦、2730
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København、丹麦、2100
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Odense、丹麦、5000
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Kemerovo、俄罗斯联邦、650036
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Moscow、俄罗斯联邦、121356
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St Petersburg、俄罗斯联邦、197758
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Plovdiv、保加利亚、4000
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Sofia、保加利亚、1756
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Sofia、保加利亚、1784
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Varna、保加利亚、9002
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-
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Alberta
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Calgary、Alberta、加拿大、T2N 4N2
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Edmonton、Alberta、加拿大、T6G 1Z2
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British Columbia
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Kelowna、British Columbia、加拿大、V1Y 5L3
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Vancouver、British Columbia、加拿大、V5Z 1H5
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Nova Scotia
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Halifax、Nova Scotia、加拿大、B3H 2Y9
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Ontario
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Ottawa、Ontario、加拿大、K1H 8L6
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Sudbury、Ontario、加拿大、J9P 3Y1
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Toronto、Ontario、加拿大、M4N 3M5
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Quebec
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Greenfield Park、Quebec、加拿大、J4V 2H1
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Montreal、Quebec、加拿大、H1T 2M4
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Montreal、Quebec、加拿大、H3T 1E2
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Montreal、Quebec、加拿大、H2W 1T8
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-
-
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Bangalore、印度、560027
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Gurgaon、印度、122001
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Kolkata、印度、700 053
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New Delhi、印度、110029
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Pune、印度、411004
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-
-
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Kaohsung、台湾、883
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Taichung、台湾、404
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Taichung、台湾、407
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Taipei、台湾、112
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Taoyuan、台湾、333
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-
-
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Bogota、哥伦比亚
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Bogota、哥伦比亚、49 00
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Monteria、哥伦比亚
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-
-
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Acapulco、墨西哥、39670
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Oaxaca、墨西哥、68000
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Toluca、墨西哥、50180
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-
-
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Kyunggi-do、大韩民国、411-769
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Seoul、大韩民国、110-744
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Seoul、大韩民国、120-752
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Seoul、大韩民国、135-710
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-
-
-
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Belo Horizonte、巴西、30150-281
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Curitiba、巴西、80530-010
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Goiania、巴西、74605-070
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Itajai、巴西、88301-220
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JAU、巴西、17210-080
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Joao Pessoa、巴西、58040280
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Porto Alegre、巴西、90610-000
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Porto Alegre、巴西、91350-200
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Porto Alegre、巴西、90430-090
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Porto Alegre - Rs、巴西、90050-170
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Rio de Janeiro、巴西、20560-120
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Rio de Janeiro、巴西、22260-020
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Santo Andre、巴西、09060-870
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Sao Paulo、巴西、1323020
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Sao Paulo、巴西、01317-000
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-
-
-
-
Aschaffenburg、德国、63739
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Berlin、德国、10367
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Berlin、德国、13125
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Berlin、德国、4169
-
Bonn、德国、53113
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Dortmund、德国、44137
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Freiburg、德国、79106
-
Fuerstenwalde、德国、15517
-
Hamburg、德国、20357
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Karlsruhe、德国、76135
-
Kiel、德国、24105
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Offenbach、德国、63069
-
Stralsund、德国、18435
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-
-
-
-
Aviano、意大利、33081
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Bologna、意大利、40138
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Candiolo、意大利、10060
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Genova、意大利、16132
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Meldola、意大利、47014
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Milano、意大利、20133
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Milano、意大利、20141
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Napoli、意大利、80131
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Negrar、意大利、37024
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Pisa、意大利、56100
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Reggio Emilia、意大利、42100
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Roma、意大利、00168
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Rozzano、意大利、20089
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Sassari、意大利、07100
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Terni、意大利、05100
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-
-
-
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Ljubljana、斯洛文尼亚、1000
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-
-
-
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Singapore、新加坡、119074
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Singapore、新加坡、169610
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-
-
-
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Newtown、新西兰、6021
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Palmerston North、新西兰、4442
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-
-
-
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Avignon、法国、84082
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Bordeaux、法国、33076
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Brest、法国、29609
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Caen、法国、14076
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Dijon、法国、21079
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La Roche Sur Yon、法国、85925
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Montpellier、法国、34298
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Paris、法国、75248
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Saint Brieuc、法国、22015
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Saint Herblain、法国、44805
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Vandoeuvre-les-nancy、法国、54511
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-
-
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Bialystok、波兰、15-027
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Gdansk、波兰、80-952
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Krakow、波兰、31-531
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Lublin、波兰、20-090
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Opole、波兰、45-060
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Poznan、波兰、61-866
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Warszawa、波兰、02-781
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-
-
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Banja Luka、波斯尼亚和黑塞哥维那、78000
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Sarajewo、波斯尼亚和黑塞哥维那、71000
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Eskilstuna、瑞典、63188
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Gaelve、瑞典、80187
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Goteborg、瑞典、40036
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Luzern、瑞士、6004
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St. Gallen、瑞士、9007
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Arizona
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Chandler、Arizona、美国、85224
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Tucson、Arizona、美国、85719
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California
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Anaheim、California、美国、92801
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Anaheim、California、美国、92807
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Bakersfield、California、美国、93309
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Baldwin Park、California、美国、91706
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Bellflower、California、美国、90706
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Duarte、California、美国、91010
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Fontana、California、美国、92335
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Hayward、California、美国、94545
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Irvine、California、美国、92618
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La Jolla、California、美国、92093
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La Mesa、California、美国、91942
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Loma Linda、California、美国、92354
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Long Beach、California、美国、90806
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Los Angeles、California、美国、90025
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Los Angeles、California、美国、90057
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Los Angeles、California、美国、90095-1772
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Los Angeles、California、美国、90034
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Montebello、California、美国、90640
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Newport Beach、California、美国、92660
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Oakland、California、美国、94611
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Panorama City、California、美国、91402
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Riverside、California、美国、92505
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Roseville、California、美国、95661
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Sacramento、California、美国、95825
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San Diego、California、美国、92123
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San Diego、California、美国、92120
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San Francisco、California、美国、94115
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San Jose、California、美国、95119
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Santa Clara、California、美国、95051
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Santa Maria、California、美国、93454
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Santa Monica、California、美国、90404
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South San Francisco、California、美国、94080
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Thousand Oaks、California、美国、91360
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Vallejo、California、美国、94589
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Walnut Creek、California、美国、94596
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Woodland Hills、California、美国、91367
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Colorado
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Fort Collins、Colorado、美国、80528
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Connecticut
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Norwalk、Connecticut、美国、06856
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Norwich、Connecticut、美国、06360
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Stamford、Connecticut、美国、06902
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District of Columbia
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Washington、District of Columbia、美国、20010
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Florida
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Boca Raton、Florida、美国、33486
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Fernandina Beach、Florida、美国、32034
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Fort Myers、Florida、美国、33916
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Ft. Lauderdale、Florida、美国、33316
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Hollywood、Florida、美国、33021
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Jacksonville、Florida、美国、32205
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Jacksonville、Florida、美国、32256
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Jacksonville、Florida、美国、32207
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Jacksonville、Florida、美国、32258
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Kissimmee、Florida、美国、34741
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Lakeland、Florida、美国、33804-1057
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Miami、Florida、美国、33136
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Miami、Florida、美国、33176
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Miami、Florida、美国、33133
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Orange Park、Florida、美国、32073
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Pembroke Pines、Florida、美国、33028
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Georgia
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Athens、Georgia、美国、30607
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Atlanta、Georgia、美国、30342
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Atlanta、Georgia、美国、30322
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Atlanta、Georgia、美国、30341
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Atlanta、Georgia、美国、30318
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Carrolton、Georgia、美国、30117
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Cartersville、Georgia、美国、30121
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Decatur、Georgia、美国、30033
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Douglasville、Georgia、美国、30134
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Macon、Georgia、美国、31217
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Marietta、Georgia、美国、30060
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Idaho
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Boise、Idaho、美国、83712
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Meridian、Idaho、美国、83642
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Nampa、Idaho、美国、83686
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Post Falls、Idaho、美国、83854
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Twin Falls、Idaho、美国、83301
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Illinois
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Chicago、Illinois、美国、60612
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Decatur、Illinois、美国、62526
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Effingham、Illinois、美国、62526
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Joliet、Illinois、美国、60435
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Morris、Illinois、美国、60450
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Peoria、Illinois、美国、61615-7828
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Skokie、Illinois、美国、60076
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Zion、Illinois、美国、60099
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Iowa
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Bettendorf、Iowa、美国、52722
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Kansas
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Wichita、Kansas、美国、67214-3728
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Kentucky
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Paducah、Kentucky、美国、42001
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Louisiana
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Covington、Louisiana、美国、70433
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Lafayette、Louisiana、美国、70503
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Marrero、Louisiana、美国、70072
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Metairie、Louisiana、美国、70006
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New Orleans、Louisiana、美国、70115
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Maine
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Kittery、Maine、美国、03904
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Wells、Maine、美国、04090
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York、Maine、美国、03909
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Maryland
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Baltimore、Maryland、美国、21202
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Baltimore、Maryland、美国、21237
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Bethesda、Maryland、美国、20817
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Rockville、Maryland、美国、20850
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Massachusetts
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Boston、Massachusetts、美国、02215
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Boston、Massachusetts、美国、02114
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Boston、Massachusetts、美国、02118
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Boston、Massachusetts、美国、02115
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Burlington、Massachusetts、美国、01805
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Peabody、Massachusetts、美国、01960
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Michigan
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Brownstown、Michigan、美国、48183
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Dearborn、Michigan、美国、48126
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Detroit、Michigan、美国、48201
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Detroit、Michigan、美国、48202
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Saint Joseph、Michigan、美国、49085
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West Bloomfield、Michigan、美国、48322
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Minnesota
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Edina、Minnesota、美国、55414
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Maplewood、Minnesota、美国、55109
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Minneapolis、Minnesota、美国、55454
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Saint Louis Park、Minnesota、美国、55426
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Saint Paul、Minnesota、美国、55101
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St. Louis Park、Minnesota、美国、55426
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Missouri
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Joplin、Missouri、美国、64804
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Kansas City、Missouri、美国、64111
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Saint Louis、Missouri、美国、63110
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Saint Peters、Missouri、美国、63110
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St. Louis、Missouri、美国、63141
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St. Peters、Missouri、美国、63376
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Montana
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Missoula、Montana、美国、59802
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Nebraska
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Omaha、Nebraska、美国、68114
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Nevada
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Henderson、Nevada、美国、89052
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New Jersey
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Cherry Hill、New Jersey、美国、08002
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Hackensack、New Jersey、美国、07601
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Morristown、New Jersey、美国、07962
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Parsippany、New Jersey、美国、07054
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Voorhees、New Jersey、美国、08043
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New Mexico
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Santa Fe、New Mexico、美国、87505
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New York
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Brockport、New York、美国、14420
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Canandaigua、New York、美国、14424
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Fresh Meadows、New York、美国、11366
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Geneva、New York、美国、14456
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Greece、New York、美国、14626
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Lake Success、New York、美国、11042
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Mount Kisco、New York、美国、10549
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Rochester、New York、美国、14626
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Stony Brook、New York、美国、11794
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North Carolina
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Charlotte、North Carolina、美国、28203
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Durham、North Carolina、美国、27710
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Hickory、North Carolina、美国、28602
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Kinston、North Carolina、美国、28501
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Washington、North Carolina、美国、27889
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Ohio
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Cleveland、Ohio、美国、44195
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Cleveland、Ohio、美国、44106
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Columbus、Ohio、美国、43215
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Columbus、Ohio、美国、43219
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Columbus、Ohio、美国、43228
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Middletown、Ohio、美国、45042
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Newark、Ohio、美国、43055
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Sandusky、Ohio、美国、44870
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Oregon
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Portland、Oregon、美国、97227
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19124
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Philadelphia、Pennsylvania、美国、19106
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Pittsburgh、Pennsylvania、美国、15232
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Pittsburgh、Pennsylvania、美国、15213
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Rhode Island
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East Providence、Rhode Island、美国、02915
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South Carolina
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Columbia、South Carolina、美国、29210
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North Charleston、South Carolina、美国、29425
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Tennessee
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Memphis、Tennessee、美国、38120
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Nashville、Tennessee、美国、37203
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Texas
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Austin、Texas、美国、78731
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Bryan、Texas、美国、77802
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Cypress、Texas、美国、77429
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Dallas、Texas、美国、75230
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El Paso、Texas、美国、79902
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Houston、Texas、美国、77090
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Shenandoah、Texas、美国、77384
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Temple、Texas、美国、76501
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Virginia
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Fairfax、Virginia、美国、22031
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Washington
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Gig Harbor、Washington、美国、98332
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Lakewood、Washington、美国、98499
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Puyallup、Washington、美国、98372
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Tacoma、Washington、美国、98405
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Wisconsin
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Milwaukee、Wisconsin、美国、53226
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Wausau、Wisconsin、美国、54401
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-
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Helsinki、芬兰、00180
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Tampere、芬兰、33520
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Turku、芬兰、20520
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-
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Bournemouth、英国、BH7 7DW
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Cardiff、英国、CF14 2TL
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Denbigh、英国、LL18 5UJ
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London、英国、SE1 7EH
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London、英国、SW3 6JJ
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Manchester、英国、M20 4BX
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New Castle Upon Tyne、英国、NE7 7DN
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Northwood、英国、HA6 2RN
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Poole、英国、BH15 2JB
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Preston、英国、PR2 9HT
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Romford、英国、RM7 0AG
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Sutton、英国、SM2 5PT
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Weston Super Mare、英国、BS23 4TQ
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Diliman, Quezon City、菲律宾、1100
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Quezon City, Luzon、菲律宾、1101
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-
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Coimbra、葡萄牙、3000-075
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Lisboa、葡萄牙、1649-035
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Porto、葡萄牙、4200-072
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-
-
-
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Barcelona、西班牙、08035
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Córdoba、西班牙、14004
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Lerida、西班牙、25198
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Madrid、西班牙、28046
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Madrid、西班牙、28041
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Santander、西班牙、39008
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Sevilla、西班牙、41013
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Valencia、西班牙、46009
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Zaragoza、西班牙、50009
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Hong Kong、香港
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- HER2 status must be prospectively, centrally tested and be HER2-positive based on central laboratory assay results
- Histologically or cytologically confirmed invasive breast cancer
- Prior treatment for breast cancer in the adjuvant, unresectable, locally advanced, or metastatic setting must include both a taxane, alone or in combination with another agent, and trastuzumab, alone or in combination with another agent
- Documented progression (which occur during or after most recent treatment or within 6 months after completing of adjuvant therapy) of incurable, unresectable, locally advanced or metastatic breast cancer, defined by the investigator
- Measurable and/or nonmeasurable disease; participants with central nervous system-only disease are excluded
- Cardiac ejection fraction greater than or equal to (>/=) 50 percent (%) by either echocardiogram or multi-gated acquisition scan
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- For women of childbearing potential and men with partners of childbearing potential, agreement to use a highly effective, non-hormonal form of contraception; contraception use should continue for the duration of the study treatment and for at least 6 months after the last dose of study treatment
Exclusion Criteria:
- History of treatment with trastuzumab emtansine
- Prior treatment with lapatinib or capecitabine
- Peripheral neuropathy of Grade >/= 3 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 3.0
- History of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage 1 uterine cancer, synchronous or previously diagnosed HER2-positive breast cancer, or cancers with a similar curative outcome as those mentioned above
- History of receiving any anti-cancer drug/biologic or investigational treatment within 21 days prior to randomization except hormone therapy, which could be given up to 7 days prior to randomization; recovery of treatment-related toxicity consistent with other eligibility criteria
- History of radiation therapy within 14 days of randomization
- Brain metastases that are untreated, symptomatic, or require therapy to control symptoms, as well as any history of radiation, surgery, or other therapy, including steroids, to control symptoms from brain metastases within 2 months (60 days) of randomization
- History of symptomatic congestive heart failure or serious cardiac arrhythmia requiring treatment
- History of myocardial infarction or unstable angina within 6 months of randomization
- Current dyspnea at rest due to complications of advanced malignancy or current requirement for continuous oxygen therapy
- Current severe, uncontrolled systemic disease (for example, clinically significant cardiovascular, pulmonary, or metabolic disease)
- Pregnancy or lactation
- Current known active infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus
- Presence of conditions that could affect gastrointestinal absorption: Malabsorption syndrome, resection of the small bowel or stomach, and ulcerative colitis
- History of intolerance (such as Grade 3-4 infusion reaction) to trastuzumab
- Known hypersensitivity to 5-fluorouracil or known dihydropyrimidine dehydrogenase deficiency
- Current treatment with sorivudine or its chemically related analogs, such as brivudine
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Trastuzumab emtansine
Participants will receive trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) intravenous (IV) infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until disease progression (PD) (as assessed by the investigator), unmanageable toxicity, or study termination.
|
Trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle.
其他名称：
|
|
有源比较器：Lapatinib + Capecitabine
Participants will receive lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 milligrams per square meter (mg/m^2) orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
Eligible participants will cross over to receive trastuzumab emtansine if second interim analysis demonstrates statistically significant overall survival benefit in favor of trastuzumab emtansine.
|
Lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle.
其他名称：
Capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle.
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Percentage of Participants With PD or Death as Assessed by an Independent Review Committee (IRC)
大体时间：From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)
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PD was assessed by an IRC using modified Response Evaluation Criteria in Solid Tumors (RECIST).
All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as target lesions (TLs) and recorded at baseline.
TLs should be selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements either by imaging or clinically.
A sum of the longest diameter for all TLs was calculated as baseline sum longest diameter (SLD).
All other lesions (or sites of disease) should be identified as non-TLs and recorded at baseline.
PD for TLs was defined as greater than or equal to (>/=) 20 percent (%) increase in SLD, taking as reference smallest SLD recorded since treatment started or appearance of 1 or more new lesions.
PD for non-TLs was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs.
Percentage of Participants with PD by IRC or death from any cause was reported.
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From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)
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Progression-free Survival (PFS) as Assessed by an IRC (Co-primary Endpoint)
大体时间：From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)
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Tumor response was assessed by an IRC according to modified RECIST.
All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as TLs (on the basis of their size and their suitability for accurate repeated measurements either by imaging or clinically) and recorded at baseline.
A sum of the longest diameter for all TLs was calculated as baseline SLD.
All other lesions were identified as non-TLs and recorded at baseline.
PD for TLs: >/= 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or appearance of 1 or more new lesions.
PD for non-TLs: appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs.
PFS: time from randomization to first documented PD by IRC or death from any cause (whichever occurred earlier).
The median duration of PFS was estimated using Kaplan-Meier method.
The 95% confidence interval (CI) was computed using the method of Brookmeyer and Crowley.
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From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)
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Percentage of Participants Who Died: Second Interim Analysis
大体时间：From the date of randomization through the data cut-off date of 31 Jul 2012 (up to 3 years, 5 months)
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The percentage of participants who died from any cause was reported.
The results are reported from second interim analysis, which deemed to be the confirmatory.
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From the date of randomization through the data cut-off date of 31 Jul 2012 (up to 3 years, 5 months)
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Overall Survival: Second Interim Analysis (Co-primary Endpoint)
大体时间：From the date of randomization through the data cut-off date of 31 Jul 2012 (up to 3 years, 5 months)
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OS was defined as the time from the date of randomization to the date of death from any cause.
The median duration of OS was estimated using Kaplan-Meier method.
The 95% CI was computed using the method of Brookmeyer and Crowley.
The results are reported from second interim analysis, which deemed to be the confirmatory.
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From the date of randomization through the data cut-off date of 31 Jul 2012 (up to 3 years, 5 months)
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Percentage of Participants Who Died: Final Analysis
大体时间：From the date of randomization through the data cut-off date of 31 Dec 2014 (up to 5 years, 11 months)
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The percentage of participants who died from any cause was reported.
The results reported are from the final analysis.
The final analysis is descriptive.
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From the date of randomization through the data cut-off date of 31 Dec 2014 (up to 5 years, 11 months)
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Overall Survival: Final Analysis
大体时间：From the date of randomization through the data cut-off date of 31 Dec 2014 (up to 5 years, 11 months)
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OS was defined as the time from the date of randomization to the date of death from any cause.
The median duration of OS was estimated using Kaplan-Meier method.
The 95% CI was computed using the method of Brookmeyer and Crowley.
The results reported are from the final analysis.
The final analysis is descriptive.
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From the date of randomization through the data cut-off date of 31 Dec 2014 (up to 5 years, 11 months)
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Percentage of Participants Who Were Alive at Year 1
大体时间：Year 1
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1 year survival was defined as the percentage of participants alive 1 year after starting treatment.
The results reported are from the final analysis.
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Year 1
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Percentage of Participants Who Were Alive at Year 2
大体时间：Year 2
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2 year survival was defined as the percentage of participants alive 2 years after starting treatment.
The results reported are from the final analysis.
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Year 2
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Percentage of Participants With PD or Death as Assessed by the Investigator
大体时间：From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)
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PD was assessed by the investigator using modified RECIST.
All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as TLs and recorded at baseline.
A sum of the longest diameter for all TLs was calculated as baseline SLD.
PD for TLs was defined as >/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions.
PD for non-TLs was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs.
The percentage of participants who died or experienced PD by Investigator was reported.
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From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)
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PFS as Assessed by the Investigator
大体时间：From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)
|
Tumor response was assessed by the investigator according to modified RECIST.
All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as TLs and recorded at baseline.
A sum of the longest diameter for all TLs was calculated as baseline SLD.
PD for TLs was defined as >/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions.
PD for non-TLs was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs.
PFS was defined as the time from randomization to first documented PD by Investigator or death from any cause (whichever occurred earlier).
The median duration of PFS was estimated using Kaplan-Meier method.
The 95% CI was computed using the method of Brookmeyer and Crowley.
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From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)
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Percentage of Participants With Objective Response (OR) as Assessed by an IRC
大体时间：From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)
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Tumor response was assessed by an IRC according to modified RECIST.
OR was defined as the percentage of participants with a complete response (CR) or partial response (PR).
All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as TLs and recorded at baseline.
A sum of the longest diameter for all TLs was calculated as baseline SLD.
For TLs, a CR was defined as the disappearance of all TLs and a PR was defined as >/= 30% decrease in the SLD of TLs, taking as reference the baseline SLD.
For non-TLs, a CR was defined as the disappearance of all non-TLs and a PR was defined as the persistence of 1 or more non-TLs.
Confirmation of response at a consecutive tumor assessment at least 4 weeks apart was required.
Participants without a post-baseline tumor assessment were considered non-responders.
The percentage of participants with CR or PR by IRC was reported.
The 95% CI was computed using Blyth-Still Casella exact CI method.
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From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)
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Duration of Objective Response (DOR) as Assessed by an IRC
大体时间：From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)
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Tumor response was assessed by an IRC according to modified RECIST.
DOR was defined as the time from first documented OR to first documented PD or death from any cause, whichever occurred earlier.
OR was defined as a CR or PR determined on 2 consecutive tumor assessments at least 4 weeks apart.
For TLs, CR was defined as the disappearance of all TLs; PR was defined as >/=30% decrease in the SLD of TLs, taking as reference the baseline SLD; and PD was defined as >/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions.
For non-TLs, CR was defined as the disappearance of all non-TLs; PR was defined as the persistence of 1 or more non-TLs; and PD was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs.
The 95% CI was computed using the method of Brookmeyer and Crowley.
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From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)
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Percentage of Participants With Clinical Benefit as Assessed by an IRC
大体时间：From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)
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Tumor response was assessed by an IRC according to modified RECIST.
Participants were considered as experienced clinical benefit if they had an OR or maintained stable disease (SD) for at least 6 months from randomization.
OR: CR or PR determined on 2 consecutive tumor assessments >/=4 weeks apart.
For TLs, CR: disappearance of all TLs; PR: >/=30% decrease in the SLD of TLs, taking as reference the baseline SLD; PD: >/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or appearance of 1 or more new lesions; and SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
For non-TLs, CR: disappearance of all non-TLs; PR/SD: persistence of 1 or more non-TLs; and PD: appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs.
Participants without a post-baseline tumor assessment were considered non-responders.
The 95% CI was computed using Blyth-Still Casella exact CI method.
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From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)
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Percentage of Participants With Treatment Failure
大体时间：From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)
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Treatment failure was defined as discontinuation of treatment for any reason, including PD (per investigator review), treatment toxicity, or death from any cause.
For "Lapatinib + Capecitabine" arm, a participant was considered as treatment failure only if both drugs were discontinued.
For TLs, PD was defined as >/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions.
For non-TLs, PD was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs.
Percentage of participants with treatment failure was reported.
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From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)
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Time to Treatment Failure
大体时间：From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)
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Time to treatment failure was defined as the time from randomization to discontinuation of treatment for any reason, including PD (per investigator review), treatment toxicity, or death from any cause.
For "Lapatinib + Capecitabine" arm, a participant was considered as treatment failure only if both drugs were discontinued with treatment failure date as the later of the 2 discontinuation dates.
For TLs, PD was defined as >/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions.
For non-TLs, PD was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs.
The median time to treatment failure was estimated using Kaplan-Meier method.
The 95% CI was computed using the method of Brookmeyer and Crowley.
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From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)
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Percentage of Participants With Symptom Progression
大体时间：From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)
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Symptom progression was defined as the documentation of a >/= 5-point decrease from baseline in the scoring of responses as measured by the Functional Assessment of Cancer Therapy-for participants with Breast Cancer (FACT-B) questionnaire with the Trial Outcomes Index-Physical/Functional/Breast (TOI-PFB) subscale.
The FACT-B TOI-PFB subscale contained 24 items from 3 subsections of the FACT-B questionnaire: Physical well-being, functional well-being, and additional concerns for breast cancer participants (breast cancer subscale [BCS]).
All items in the questionnaire were rated by the participant on a 5-point scale ranging from 0 ("not at all") to 4 ("very much").
The total score ranged from 0 to 96 with higher score indicating better perceived quality of life.
The percentage of participants with symptom progression was reported.
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From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)
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Time to Symptom Progression
大体时间：From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)
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Time to symptom progression was defined as the time from randomization to the first documentation of a >/= 5-point decrease from baseline in the scoring of responses as measured by the FACT-B questionnaire with the TOI-PFB subscale.
The FACT-B TOI-PFB subscale contained 24 items from 3 subsections of the FACT-B questionnaire: Physical well-being, functional well-being, and additional concerns for breast cancer participants (BCS).
All items in the questionnaire were rated by the participant on a 5-point scale ranging from 0 ("not at all") to 4 ("very much").
The total score ranged from 0 to 96 with higher score indicating better perceived quality of life.
The median time to symptom progression was estimated using Kaplan-Meier method.
The 95% CI was computed using the method of Brookmeyer and Crowley.
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From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Scott AM, Wolchok JD, Old LJ. Antibody therapy of cancer. Nat Rev Cancer. 2012 Mar 22;12(4):278-87. doi: 10.1038/nrc3236.
- Dieras V, Miles D, Verma S, Pegram M, Welslau M, Baselga J, Krop IE, Blackwell K, Hoersch S, Xu J, Green M, Gianni L. Trastuzumab emtansine versus capecitabine plus lapatinib in patients with previously treated HER2-positive advanced breast cancer (EMILIA): a descriptive analysis of final overall survival results from a randomised, open-label, phase 3 trial. Lancet Oncol. 2017 Jun;18(6):732-742. doi: 10.1016/S1470-2045(17)30312-1. Epub 2017 May 16. Erratum In: Lancet Oncol. 2017 Aug;18(8):e433. Lancet Oncol. 2018 Dec;19(12):e667.
- Verma S, Miles D, Gianni L, Krop IE, Welslau M, Baselga J, Pegram M, Oh DY, Dieras V, Guardino E, Fang L, Lu MW, Olsen S, Blackwell K; EMILIA Study Group. Trastuzumab emtansine for HER2-positive advanced breast cancer. N Engl J Med. 2012 Nov 8;367(19):1783-91. doi: 10.1056/NEJMoa1209124. Epub 2012 Oct 1. Erratum In: N Engl J Med. 2013 Jun 20;368(25):2442.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2009年2月1日
初级完成 (实际的)
2012年7月1日
研究完成 (实际的)
2015年9月1日
研究注册日期
首次提交
2009年1月22日
首先提交符合 QC 标准的
2009年1月22日
首次发布 (估计)
2009年1月26日
研究记录更新
最后更新发布 (估计)
2016年10月31日
上次提交的符合 QC 标准的更新
2016年9月10日
最后验证
2016年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Trastuzumab emtansine的临床试验
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UNICANCER尚未招聘肿瘤转移 | 三阴性乳腺肿瘤 | HER 2 低表达乳腺癌法国
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Fundación Pública Andaluza para la Investigación...招聘中乳腺癌 | 转移性乳腺癌 | 药物相关的副作用和不良反应 | Pharmacogenetic Variant西班牙
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Kristina A. FanucciStemline Therapeutics, Inc.招聘中根除：CDK4/6抑制剂和耐内分泌的HR+/HER2-LOW或HER2-硫酸转移性乳腺癌的患者的Elacestrant Plus曲妥珠单抗Deruxtecan的IB/II期研究 (ERADICATE)乳腺癌 | 转移性乳腺癌 | 乳腺癌女性 | HER2 阴性乳腺癌 | HER2低位乳腺癌美国
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SOLTI Breast Cancer Research GroupUNICANCER; Westdeutsche Studiengruppe GmbH (WSG)招聘中
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Memorial Sloan Kettering Cancer CenterAstraZeneca招聘中
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Nagoya City University主动，不招人
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BioNTech SEDualityBio Inc.; BioNTech (Shanghai) Pharmaceuticals Co., Ltd.招聘中转移性乳腺癌 | 局部晚期乳腺癌 | 不可切除的乳腺癌美国, 法国, 中国, 英国, 加拿大, 乔治亚州, 意大利, 土耳其（türkiye）, 摩尔多瓦
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Daiichi SankyoAstraZeneca; Daiichi Sankyo Co., Ltd.主动，不招人乳腺癌美国, 加拿大, 西班牙, 比利时, 中国, 台湾, 澳大利亚, 意大利, 日本, 法国, 英国, 巴西, 德国, 香港, 韩国