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A Study of Trastuzumab Emtansine Versus Capecitabine + Lapatinib in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer (EMILIA)

2016년 9월 10일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

991

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 뉴질랜드
      • Newtown, 뉴질랜드, 6021
      • Palmerston North, 뉴질랜드, 4442
  • 대만
      • Kaohsung, 대만, 883
      • Taichung, 대만, 404
      • Taichung, 대만, 407
      • Taipei, 대만, 112
      • Taoyuan, 대만, 333
  • 대한민국
      • Kyunggi-do, 대한민국, 411-769
      • Seoul, 대한민국, 110-744
      • Seoul, 대한민국, 120-752
      • Seoul, 대한민국, 135-710
  • 덴마크
      • Herlev, 덴마크, 2730
      • København, 덴마크, 2100
      • Odense, 덴마크, 5000
  • 독일
      • Aschaffenburg, 독일, 63739
      • Berlin, 독일, 10367
      • Berlin, 독일, 13125
      • Berlin, 독일, 4169
      • Bonn, 독일, 53113
      • Dortmund, 독일, 44137
      • Freiburg, 독일, 79106
      • Fuerstenwalde, 독일, 15517
      • Hamburg, 독일, 20357
      • Karlsruhe, 독일, 76135
      • Kiel, 독일, 24105
      • Offenbach, 독일, 63069
      • Stralsund, 독일, 18435
  • 러시아 연방
      • Kemerovo, 러시아 연방, 650036
      • Moscow, 러시아 연방, 121356
      • St Petersburg, 러시아 연방, 197758
  • 멕시코
      • Acapulco, 멕시코, 39670
      • Oaxaca, 멕시코, 68000
      • Toluca, 멕시코, 50180
  • 미국
    • Arizona
      • Chandler, Arizona, 미국, 85224
      • Tucson, Arizona, 미국, 85719
    • California
      • Anaheim, California, 미국, 92801
      • Anaheim, California, 미국, 92807
      • Bakersfield, California, 미국, 93309
      • Baldwin Park, California, 미국, 91706
      • Bellflower, California, 미국, 90706
      • Duarte, California, 미국, 91010
      • Fontana, California, 미국, 92335
      • Hayward, California, 미국, 94545
      • Irvine, California, 미국, 92618
      • La Jolla, California, 미국, 92093
      • La Mesa, California, 미국, 91942
      • Loma Linda, California, 미국, 92354
      • Long Beach, California, 미국, 90806
      • Los Angeles, California, 미국, 90025
      • Los Angeles, California, 미국, 90057
      • Los Angeles, California, 미국, 90095-1772
      • Los Angeles, California, 미국, 90034
      • Montebello, California, 미국, 90640
      • Newport Beach, California, 미국, 92660
      • Oakland, California, 미국, 94611
      • Panorama City, California, 미국, 91402
      • Riverside, California, 미국, 92505
      • Roseville, California, 미국, 95661
      • Sacramento, California, 미국, 95825
      • San Diego, California, 미국, 92123
      • San Diego, California, 미국, 92120
      • San Francisco, California, 미국, 94115
      • San Jose, California, 미국, 95119
      • Santa Clara, California, 미국, 95051
      • Santa Maria, California, 미국, 93454
      • Santa Monica, California, 미국, 90404
      • South San Francisco, California, 미국, 94080
      • Thousand Oaks, California, 미국, 91360
      • Vallejo, California, 미국, 94589
      • Walnut Creek, California, 미국, 94596
      • Woodland Hills, California, 미국, 91367
    • Colorado
      • Fort Collins, Colorado, 미국, 80528
    • Connecticut
      • Norwalk, Connecticut, 미국, 06856
      • Norwich, Connecticut, 미국, 06360
      • Stamford, Connecticut, 미국, 06902
    • District of Columbia
      • Washington, District of Columbia, 미국, 20010
    • Florida
      • Boca Raton, Florida, 미국, 33486
      • Fernandina Beach, Florida, 미국, 32034
      • Fort Myers, Florida, 미국, 33916
      • Ft. Lauderdale, Florida, 미국, 33316
      • Hollywood, Florida, 미국, 33021
      • Jacksonville, Florida, 미국, 32205
      • Jacksonville, Florida, 미국, 32256
      • Jacksonville, Florida, 미국, 32207
      • Jacksonville, Florida, 미국, 32258
      • Kissimmee, Florida, 미국, 34741
      • Lakeland, Florida, 미국, 33804-1057
      • Miami, Florida, 미국, 33136
      • Miami, Florida, 미국, 33176
      • Miami, Florida, 미국, 33133
      • Orange Park, Florida, 미국, 32073
      • Pembroke Pines, Florida, 미국, 33028
    • Georgia
      • Athens, Georgia, 미국, 30607
      • Atlanta, Georgia, 미국, 30342
      • Atlanta, Georgia, 미국, 30322
      • Atlanta, Georgia, 미국, 30341
      • Atlanta, Georgia, 미국, 30318
      • Carrolton, Georgia, 미국, 30117
      • Cartersville, Georgia, 미국, 30121
      • Decatur, Georgia, 미국, 30033
      • Douglasville, Georgia, 미국, 30134
      • Macon, Georgia, 미국, 31217
      • Marietta, Georgia, 미국, 30060
    • Idaho
      • Boise, Idaho, 미국, 83712
      • Meridian, Idaho, 미국, 83642
      • Nampa, Idaho, 미국, 83686
      • Post Falls, Idaho, 미국, 83854
      • Twin Falls, Idaho, 미국, 83301
    • Illinois
      • Chicago, Illinois, 미국, 60612
      • Decatur, Illinois, 미국, 62526
      • Effingham, Illinois, 미국, 62526
      • Joliet, Illinois, 미국, 60435
      • Morris, Illinois, 미국, 60450
      • Peoria, Illinois, 미국, 61615-7828
      • Skokie, Illinois, 미국, 60076
      • Zion, Illinois, 미국, 60099
    • Iowa
      • Bettendorf, Iowa, 미국, 52722
    • Kansas
      • Wichita, Kansas, 미국, 67214-3728
    • Kentucky
      • Paducah, Kentucky, 미국, 42001
    • Louisiana
      • Covington, Louisiana, 미국, 70433
      • Lafayette, Louisiana, 미국, 70503
      • Marrero, Louisiana, 미국, 70072
      • Metairie, Louisiana, 미국, 70006
      • New Orleans, Louisiana, 미국, 70115
    • Maine
      • Kittery, Maine, 미국, 03904
      • Wells, Maine, 미국, 04090
      • York, Maine, 미국, 03909
    • Maryland
      • Baltimore, Maryland, 미국, 21202
      • Baltimore, Maryland, 미국, 21237
      • Bethesda, Maryland, 미국, 20817
      • Rockville, Maryland, 미국, 20850
    • Massachusetts
      • Boston, Massachusetts, 미국, 02215
      • Boston, Massachusetts, 미국, 02114
      • Boston, Massachusetts, 미국, 02118
      • Boston, Massachusetts, 미국, 02115
      • Burlington, Massachusetts, 미국, 01805
      • Peabody, Massachusetts, 미국, 01960
    • Michigan
      • Brownstown, Michigan, 미국, 48183
      • Dearborn, Michigan, 미국, 48126
      • Detroit, Michigan, 미국, 48201
      • Detroit, Michigan, 미국, 48202
      • Saint Joseph, Michigan, 미국, 49085
      • West Bloomfield, Michigan, 미국, 48322
    • Minnesota
      • Edina, Minnesota, 미국, 55414
      • Maplewood, Minnesota, 미국, 55109
      • Minneapolis, Minnesota, 미국, 55454
      • Saint Louis Park, Minnesota, 미국, 55426
      • Saint Paul, Minnesota, 미국, 55101
      • St. Louis Park, Minnesota, 미국, 55426
    • Missouri
      • Joplin, Missouri, 미국, 64804
      • Kansas City, Missouri, 미국, 64111
      • Saint Louis, Missouri, 미국, 63110
      • Saint Peters, Missouri, 미국, 63110
      • St. Louis, Missouri, 미국, 63141
      • St. Peters, Missouri, 미국, 63376
    • Montana
      • Missoula, Montana, 미국, 59802
    • Nebraska
      • Omaha, Nebraska, 미국, 68114
    • Nevada
      • Henderson, Nevada, 미국, 89052
    • New Jersey
      • Cherry Hill, New Jersey, 미국, 08002
      • Hackensack, New Jersey, 미국, 07601
      • Morristown, New Jersey, 미국, 07962
      • Parsippany, New Jersey, 미국, 07054
      • Voorhees, New Jersey, 미국, 08043
    • New Mexico
      • Santa Fe, New Mexico, 미국, 87505
    • New York
      • Brockport, New York, 미국, 14420
      • Canandaigua, New York, 미국, 14424
      • Fresh Meadows, New York, 미국, 11366
      • Geneva, New York, 미국, 14456
      • Greece, New York, 미국, 14626
      • Lake Success, New York, 미국, 11042
      • Mount Kisco, New York, 미국, 10549
      • Rochester, New York, 미국, 14626
      • Stony Brook, New York, 미국, 11794
    • North Carolina
      • Charlotte, North Carolina, 미국, 28203
      • Durham, North Carolina, 미국, 27710
      • Hickory, North Carolina, 미국, 28602
      • Kinston, North Carolina, 미국, 28501
      • Washington, North Carolina, 미국, 27889
    • Ohio
      • Cleveland, Ohio, 미국, 44195
      • Cleveland, Ohio, 미국, 44106
      • Columbus, Ohio, 미국, 43215
      • Columbus, Ohio, 미국, 43219
      • Columbus, Ohio, 미국, 43228
      • Middletown, Ohio, 미국, 45042
      • Newark, Ohio, 미국, 43055
      • Sandusky, Ohio, 미국, 44870
    • Oregon
      • Portland, Oregon, 미국, 97227
    • Pennsylvania
      • Philadelphia, Pennsylvania, 미국, 19124
      • Philadelphia, Pennsylvania, 미국, 19106
      • Pittsburgh, Pennsylvania, 미국, 15232
      • Pittsburgh, Pennsylvania, 미국, 15213
    • Rhode Island
      • East Providence, Rhode Island, 미국, 02915
    • South Carolina
      • Columbia, South Carolina, 미국, 29210
      • North Charleston, South Carolina, 미국, 29425
    • Tennessee
      • Memphis, Tennessee, 미국, 38120
      • Nashville, Tennessee, 미국, 37203
    • Texas
      • Austin, Texas, 미국, 78731
      • Bryan, Texas, 미국, 77802
      • Cypress, Texas, 미국, 77429
      • Dallas, Texas, 미국, 75230
      • El Paso, Texas, 미국, 79902
      • Houston, Texas, 미국, 77090
      • Shenandoah, Texas, 미국, 77384
      • Temple, Texas, 미국, 76501
    • Virginia
      • Fairfax, Virginia, 미국, 22031
    • Washington
      • Gig Harbor, Washington, 미국, 98332
      • Lakewood, Washington, 미국, 98499
      • Puyallup, Washington, 미국, 98372
      • Tacoma, Washington, 미국, 98405
    • Wisconsin
      • Milwaukee, Wisconsin, 미국, 53226
      • Wausau, Wisconsin, 미국, 54401
  • 보스니아 헤르체고비나
      • Banja Luka, 보스니아 헤르체고비나, 78000
      • Sarajewo, 보스니아 헤르체고비나, 71000
  • 불가리아
      • Plovdiv, 불가리아, 4000
      • Sofia, 불가리아, 1756
      • Sofia, 불가리아, 1784
      • Varna, 불가리아, 9002
  • 브라질
      • Belo Horizonte, 브라질, 30150-281
      • Curitiba, 브라질, 80530-010
      • Goiania, 브라질, 74605-070
      • Itajai, 브라질, 88301-220
      • JAU, 브라질, 17210-080
      • Joao Pessoa, 브라질, 58040280
      • Porto Alegre, 브라질, 90610-000
      • Porto Alegre, 브라질, 91350-200
      • Porto Alegre, 브라질, 90430-090
      • Porto Alegre - Rs, 브라질, 90050-170
      • Rio de Janeiro, 브라질, 20560-120
      • Rio de Janeiro, 브라질, 22260-020
      • Santo Andre, 브라질, 09060-870
      • Sao Paulo, 브라질, 1323020
      • Sao Paulo, 브라질, 01317-000
  • 스웨덴
      • Eskilstuna, 스웨덴, 63188
      • Gaelve, 스웨덴, 80187
      • Goteborg, 스웨덴, 40036
  • 스위스
      • Luzern, 스위스, 6004
      • St. Gallen, 스위스, 9007
  • 스페인
      • Barcelona, 스페인, 08035
      • Córdoba, 스페인, 14004
      • Lerida, 스페인, 25198
      • Madrid, 스페인, 28046
      • Madrid, 스페인, 28041
      • Santander, 스페인, 39008
      • Sevilla, 스페인, 41013
      • Valencia, 스페인, 46009
      • Zaragoza, 스페인, 50009
  • 슬로베니아
      • Ljubljana, 슬로베니아, 1000
  • 싱가포르
      • Singapore, 싱가포르, 119074
      • Singapore, 싱가포르, 169610
  • 영국
      • Bournemouth, 영국, BH7 7DW
      • Cardiff, 영국, CF14 2TL
      • Denbigh, 영국, LL18 5UJ
      • London, 영국, SE1 7EH
      • London, 영국, SW3 6JJ
      • Manchester, 영국, M20 4BX
      • New Castle Upon Tyne, 영국, NE7 7DN
      • Northwood, 영국, HA6 2RN
      • Poole, 영국, BH15 2JB
      • Preston, 영국, PR2 9HT
      • Romford, 영국, RM7 0AG
      • Sutton, 영국, SM2 5PT
      • Weston Super Mare, 영국, BS23 4TQ
  • 이탈리아
      • Aviano, 이탈리아, 33081
      • Bologna, 이탈리아, 40138
      • Candiolo, 이탈리아, 10060
      • Genova, 이탈리아, 16132
      • Meldola, 이탈리아, 47014
      • Milano, 이탈리아, 20133
      • Milano, 이탈리아, 20141
      • Napoli, 이탈리아, 80131
      • Negrar, 이탈리아, 37024
      • Pisa, 이탈리아, 56100
      • Reggio Emilia, 이탈리아, 42100
      • Roma, 이탈리아, 00168
      • Rozzano, 이탈리아, 20089
      • Sassari, 이탈리아, 07100
      • Terni, 이탈리아, 05100
  • 인도
      • Bangalore, 인도, 560027
      • Gurgaon, 인도, 122001
      • Kolkata, 인도, 700 053
      • New Delhi, 인도, 110029
      • Pune, 인도, 411004
  • 캐나다
    • Alberta
      • Calgary, Alberta, 캐나다, T2N 4N2
      • Edmonton, Alberta, 캐나다, T6G 1Z2
    • British Columbia
      • Kelowna, British Columbia, 캐나다, V1Y 5L3
      • Vancouver, British Columbia, 캐나다, V5Z 1H5
    • Nova Scotia
      • Halifax, Nova Scotia, 캐나다, B3H 2Y9
    • Ontario
      • Ottawa, Ontario, 캐나다, K1H 8L6
      • Sudbury, Ontario, 캐나다, J9P 3Y1
      • Toronto, Ontario, 캐나다, M4N 3M5
    • Quebec
      • Greenfield Park, Quebec, 캐나다, J4V 2H1
      • Montreal, Quebec, 캐나다, H1T 2M4
      • Montreal, Quebec, 캐나다, H3T 1E2
      • Montreal, Quebec, 캐나다, H2W 1T8
  • 콜롬비아
      • Bogota, 콜롬비아
      • Bogota, 콜롬비아, 49 00
      • Monteria, 콜롬비아
  • 포르투갈
      • Coimbra, 포르투갈, 3000-075
      • Lisboa, 포르투갈, 1649-035
      • Porto, 포르투갈, 4200-072
  • 폴란드
      • Bialystok, 폴란드, 15-027
      • Gdansk, 폴란드, 80-952
      • Krakow, 폴란드, 31-531
      • Lublin, 폴란드, 20-090
      • Opole, 폴란드, 45-060
      • Poznan, 폴란드, 61-866
      • Warszawa, 폴란드, 02-781
  • 프랑스
      • Avignon, 프랑스, 84082
      • Bordeaux, 프랑스, 33076
      • Brest, 프랑스, 29609
      • Caen, 프랑스, 14076
      • Dijon, 프랑스, 21079
      • La Roche Sur Yon, 프랑스, 85925
      • Montpellier, 프랑스, 34298
      • Paris, 프랑스, 75248
      • Saint Brieuc, 프랑스, 22015
      • Saint Herblain, 프랑스, 44805
      • Vandoeuvre-les-nancy, 프랑스, 54511
  • 핀란드
      • Helsinki, 핀란드, 00180
      • Tampere, 핀란드, 33520
      • Turku, 핀란드, 20520
  • 필리핀 제도
      • Diliman, Quezon City, 필리핀 제도, 1100
      • Quezon City, Luzon, 필리핀 제도, 1101
  • 홍콩
      • Hong Kong, 홍콩

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
의약품: Trastuzumab emtansine
Trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle.
다른 이름들:
  • RO5304020
  • T-DM1
  • 트라스투주맙-MCC-DM1
활성 비교기: 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.
의약품: Lapatinib
Lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle.
다른 이름들:
  • 타이커브
  • 티버브
의약품: Capecitabine
Capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle.
다른 이름들:
  • 젤로다

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Percentage of Participants With PD or Death as Assessed by an Independent Review Committee (IRC)
기간: From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)
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.
From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)
Progression-free Survival (PFS) as Assessed by an IRC (Co-primary Endpoint)
기간: 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 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.
From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)
Percentage of Participants Who Died: Second Interim Analysis
기간: From the date of randomization through the data cut-off date of 31 Jul 2012 (up to 3 years, 5 months)
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.
From the date of randomization through the data cut-off date of 31 Jul 2012 (up to 3 years, 5 months)
Overall Survival: Second Interim Analysis (Co-primary Endpoint)
기간: From the date of randomization through the data cut-off date of 31 Jul 2012 (up to 3 years, 5 months)
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.
From the date of randomization through the data cut-off date of 31 Jul 2012 (up to 3 years, 5 months)
Percentage of Participants Who Died: Final Analysis
기간: From the date of randomization through the data cut-off date of 31 Dec 2014 (up to 5 years, 11 months)
The percentage of participants who died from any cause was reported. The results reported are from the final analysis. The final analysis is descriptive.
From the date of randomization through the data cut-off date of 31 Dec 2014 (up to 5 years, 11 months)
Overall Survival: Final Analysis
기간: From the date of randomization through the data cut-off date of 31 Dec 2014 (up to 5 years, 11 months)
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.
From the date of randomization through the data cut-off date of 31 Dec 2014 (up to 5 years, 11 months)
Percentage of Participants Who Were Alive at Year 1
기간: Year 1
1 year survival was defined as the percentage of participants alive 1 year after starting treatment. The results reported are from the final analysis.
Year 1
Percentage of Participants Who Were Alive at Year 2
기간: Year 2
2 year survival was defined as the percentage of participants alive 2 years after starting treatment. The results reported are from the final analysis.
Year 2

2차 결과 측정

결과 측정
측정값 설명
기간
Percentage of Participants With PD or Death as Assessed by the Investigator
기간: From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)
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.
From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)
PFS as Assessed by the Investigator
기간: 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.
From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)
Percentage of Participants With Objective Response (OR) as Assessed by an IRC
기간: 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 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.
From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)
Duration of Objective Response (DOR) as Assessed by an IRC
기간: 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 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.
From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)
Percentage of Participants With Clinical Benefit as Assessed by an IRC
기간: 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 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.
From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)
Percentage of Participants With Treatment Failure
기간: From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)
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.
From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)
Time to Treatment Failure
기간: From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)
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.
From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)
Percentage of Participants With Symptom Progression
기간: From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)
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.
From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)
Time to Symptom Progression
기간: From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)
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.
From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Hoffmann-La Roche

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2009년 2월 1일

기본 완료 (실제)

2012년 7월 1일

연구 완료 (실제)

2015년 9월 1일

연구 등록 날짜

최초 제출

2009년 1월 22일

QC 기준을 충족하는 최초 제출

2009년 1월 22일

처음 게시됨 (추정)

2009년 1월 26일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2016년 10월 31일

QC 기준을 충족하는 마지막 업데이트 제출

2016년 9월 10일

마지막으로 확인됨

2016년 9월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • BO21977
  • TDM4370g (기타 식별자: Genentech)

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

유방암에 대한 임상 시험

Trastuzumab emtansine에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Mozambique

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다