Эта страница была переведена автоматически, точность перевода не гарантируется. Пожалуйста, обратитесь к английской версии для исходного текста.

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

10 сентября 2016 г. обновлено: 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.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Действительный)

991

Фаза

  • Фаза 3

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

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

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

18 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

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

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: 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.
Лекарство: Trastuzumab emtansine
Trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle.
Другие имена:
  • РО5304020
  • Т-ДМ1
  • Трастузумаб-MCC-DM1
Активный компаратор: 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.
Лекарство: Lapatinib
Lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle.
Другие имена:
  • Тыкерб
  • Тайверб
Лекарство: Capecitabine
Capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle.
Другие имена:
  • Кселода

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Percentage of Participants With PD or Death as Assessed by an Independent Review Committee (IRC)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Percentage of Participants With PD or Death as Assessed by the Investigator
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Hoffmann-La Roche

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования

1 февраля 2009 г.

Первичное завершение (Действительный)

1 июля 2012 г.

Завершение исследования (Действительный)

1 сентября 2015 г.

Даты регистрации исследования

Первый отправленный

22 января 2009 г.

Впервые представлено, что соответствует критериям контроля качества

22 января 2009 г.

Первый опубликованный (Оценивать)

26 января 2009 г.

Обновления учебных записей

Последнее опубликованное обновление (Оценивать)

31 октября 2016 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

10 сентября 2016 г.

Последняя проверка

1 сентября 2016 г.

Дополнительная информация

Термины, связанные с этим исследованием

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • BO21977
  • TDM4370g (Другой идентификатор: Genentech)

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

Клинические исследования Рак молочной железы

Клинические исследования Trastuzumab emtansine

Искать похожие исследования

Спонсоры и соавторы

Заболевания

Медикаментозные вмешательства

CROs by country

CROs in Colombia

Заболевания

Редкие заболевания

Медикаментозные вмешательства

Пищевые добавки

Спонсор / Соавторы

Места

Подписаться