전이성 HER2+ 유방암에 대한 Trastuzumab 및 Pertuzumab과 함께 Tucatinib 또는 위약에 대한 연구 (HER2CLIMB-05)
전이성 HER2+ 유방암(HER2CLIMB-05)에 대한 유지 요법으로서 Trastuzumab 및 Pertuzumab과 병용한 Tucatinib 또는 위약에 대한 무작위 이중 맹검 3상 연구
This study is being done to see if tucatinib works better than placebo when given with other drugs to treat participants with HER2-positive breast cancer. A placebo is a pill that looks the same as tucatinib but has no medicine in it. This study will also test what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease.
Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic).
In this study, all participants will get either tucatinib or placebo. Participants will be assigned randomly to a group. This is a blinded study, so patients and their doctors will not know which group a participant is in.
All participants will also get trastuzumab and pertuzumab. These are 2 drugs used to treat this type of cancer.
연구 개요
상태
정황
상세 설명
Control arm: Placebo given orally twice daily plus trastuzumab and pertuzumab every 21 days
Experimental arm: Tucatinib 300 mg given orally twice daily plus trastuzumab and pertuzumab every 21 days
Trastuzumab and pertuzumab will be administered as follows:
• Trastuzumab will be given intravenously (IV) at a dose of 6 mg/kg or subcutaneously (SC) at a fixed dose of 600 mg, once every 21 days.
AND
- Pertuzumab will be given IV at 420 mg every 21 days. OR
- Fixed dose combination of 600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase will be given SC, once every 21 days, in lieu of trastuzumab and pertuzumab individually.
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
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Larissa, 그리스, 41110
- University General Hospital of Larissa, Oncology Clinic
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Marousi, 그리스, 15123
- IASO General Clinic Oncology Clinic
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Pireaus, 그리스, 18537
- Metaxa Anticancer Hospital of Piraeus
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Attica
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Athens, Attica, 그리스, 11528
- General Hospital of Athens "Alexandra" Clinical Therapeutics Department, Hematology/Oncology Unit
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Peloponnese
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Patra, Peloponnese, 그리스, 26504
- University General Hospital of Patras, Oncology Department, Internal Medicine Clinic
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-
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Dordrecht, 네덜란드, 3318 AT
- Albert Schweitzer Ziekenhuis
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Utrecht, 네덜란드, 3543 AZ
- St. Antonius Hospital
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Venlo, 네덜란드, 5912 BL
- VieCuri Medsich Centrum
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South Holland
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Doedrecht, South Holland, 네덜란드, 3318AT
- Albert Schweitzer Hospital
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-
-
-
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Changhua, 대만, 500 (R.O.C.)
- Changhua Christian Medical Foundation Changhua Christian Hospital
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Kaohsiung City, 대만, 807
- Kaohsiung Medical University Chung-Ho Memorial Hospital
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New Taipei City, 대만, 23561 (R.O.C.)
- Taipei Medical University-Shuang Ho Hospital, Ministry of Health and Welfare
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New Taipei City, 대만, 23561 (R.O.C)
- Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare
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Taichung, 대만, 40447 (R.O.C.)
- China Medical University Hospital
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Taipei, 대만, 11217
- Taipei Veterans General Hospital
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Taipei, 대만, 11490, R.O.C.
- Tri-Service General Hospital
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Taoyuan City, 대만, 333
- Chang Gung Memorial Hospital LinKou
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Other
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Tainan, Other, 대만, 704
- National Cheng Kung University Hospital
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Taipei, Other, 대만, 10449
- MacKay Medical Foundation The Presbyterian Church in Taiwan MacKay Memorial Hospital
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Taipei, Other, 대만, 112
- Koo Foundation Sun Yat-Sen Cancer Center
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R.o.c
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Taipei, R.o.c, 대만, 100
- National Taiwan University Hospital
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Tainan
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Tainan, Tainan, 대만, 710
- Chi Mei Medical Center
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-
-
-
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Busan, 대한민국, 49201
- Dong-A University Hospital
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Incheon, 대한민국, 21565
- Gachon University Gil Medical Center
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Seoul, 대한민국, 02841
- Korea University Anam Hospital
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Gangwon-do
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Wŏnju, Gangwon-do, 대한민국, 26426
- Yonsei University Wonju Severance Christian Hospital
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Gyeonggi-do
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Goyang-si, Gyeonggi-do, 대한민국, 10408
- National Cancer Center
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Seongnam-si, Gyeonggi-do, 대한민국, 13620
- Seoul National University Bundang Hospital
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Suwon, Gyeonggi-do, 대한민국, 16247
- The Catholic University of Korea, St. Vincent's Hospital
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Suwon, Gyeonggi-do, 대한민국, 16499
- Ajou University Hospital
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North Chungcheong
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Cheongju-si, North Chungcheong, 대한민국, 28644
- Chungbuk Nationl University Hospital
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Other
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Seoul, Other, 대한민국, 03080
- Seoul National University Hospital
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Seoul, Other, 대한민국, 05505
- Asan Medical Center
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Seoul, Other, 대한민국, 06273
- Gangnam Severance Hospital, Yonsei University Health System
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Seoul, Other, 대한민국, 06591
- The Catholic University of Korea, Seoul St. Mary's Hospital
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Seoul, Other, 대한민국, 07985
- Ewha Womans University Mokdong Hospital
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Seoul-teukbyeolsi [seoul]
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Seoul, Seoul-teukbyeolsi [seoul], 대한민국, 03722
- Severance Hospital Yonsei University Health System
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-
-
-
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Augsburg, 독일, 86156
- "Universitatsklinikum Augsburg Klinik fur Frauenheilkunde und Geburtshilfe"
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Berlin, 독일, 10117
- Charite Universtitatsmedizin Berlin Klinik fur Gynakologie mit Brustzentrum
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Berlin, 독일, 13353
- Charite - Universitatsmedizin Berlin
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Hamburg, 독일, 20246
- Universitatsklinikum Hamburg-Eppendorf (UKE)
-
München, 독일, 81675
- Klinik und Poliklinik fur Frauenheilkunde der Technischen Universitat Munchen
-
Ulm, 독일, 89075
- Universitatsklinikum Ulm Klinik fur Frauenheilkunde und Geburtshilfe
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Würzburg, 독일, 97080
- Universitatsklinikum Wurzburg Frauenklinik und Poliklinik
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Würzburg, 독일, 97080
- Universitatsklinikum Wurzburg, Comprehensive Cancer Center - Mainfranken (CCCMF)
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North Rhine-Westphalia
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Münster, North Rhine-Westphalia, 독일, 48149
- University Hospital Muenster Senology
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Other
-
Manheim, Other, 독일, 68167
- Universitätsmedizin Mannheim Universitätsfrauenklinik
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Mannheim, Other, 독일, 68167
- Pharmacy:Fortuna Herstellung GmbH
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-
-
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Arizona
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Phoenix, Arizona, 미국, 85054
- Mayo Clinic Hospital
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Scottsdale, Arizona, 미국, 85259
- Mayo Clinic
-
-
Arkansas
-
Little Rock, Arkansas, 미국, 72205
- Central Arkansas Radiation Therapy Institute Inc d.b.a CARTI
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California
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Beverly Hills, California, 미국, 90212
- UCLA Hematology/Oncology - Beverly Hills
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Burbank, California, 미국, 91505
- UCLA Hematology/Oncology - Burbank
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Encinitas, California, 미국, 92024
- UCSD Medical Center - Encinitas
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La Jolla, California, 미국, 92093
- UC San Diego Moores Cancer Center
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La Jolla, California, 미국, 92037
- Sulpizio Cardiovascular Center at UC San Diego Health
-
La Jolla, California, 미국, 92037
- UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)
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La Jolla, California, 미국, 92037
- UCSD Perlman Medical Offices
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La Jolla, California, 미국, 92037
- UCSD Koman Family Outpatient Pavilion
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Laguna Hills, California, 미국, 92653
- UCLA Hematology/Oncology - Laguna Hills
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Los Angeles, California, 미국, 90095
- UCLA Hematology/Oncology
-
Los Angeles, California, 미국, 90095
- Administrative Address: UCLA Hematology/Oncology
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San Diego, California, 미국, 92103
- UC San Diego Medical Center - Hillcrest
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San Diego, California, 미국, 912101
- UCSD Medical Center - Bankers Hill
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San Luis Obispo, California, 미국, 93401
- UCLA Hematology/Oncology - San Luis Obispo
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Santa Barbara, California, 미국, 93101
- UCLA Hematology/Oncology- Santa Barbara
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Santa Monica, California, 미국, 90404
- UCLA Hematology/Oncology - Santa Monica
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Santa Monica, California, 미국, 90404
- UCLA Hematology/Oncology Parkside
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Torrance, California, 미국, 90509
- Harbor-UCLA Medical Center
-
Torrance, California, 미국, 90502
- The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
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Torrance, California, 미국, 90502
- Clinical And Translational Research Center
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Valencia, California, 미국, 91355
- UCLA Hematology/Oncology - Santa Clarita
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Vista, California, 미국, 92081
- UCSD Medical Center - Vista
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Westlake Village, California, 미국, 91361
- UCLA Hematology/Oncology- Westlake
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Florida
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Altamonte Springs, Florida, 미국, 32701
- AdventHealth Altamonte Infusion Center
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Altamonte Springs, Florida, 미국, 32701
- AdventHealth Medical Group Altamonte(second location)
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Altamonte Springs, Florida, 미국, 32701
- AdventHealth Medical Group Altamonte
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Jacksonville, Florida, 미국, 32224
- Mayo Clinic Florida
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Orlando, Florida, 미국, 32804
- AdventHealth Orlando Infusion Center
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Orlando, Florida, 미국, 32804
- AdventHealth Medical Group Orlando
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Georgia
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Atlanta, Georgia, 미국, 30308
- Emory University Hospital Midtown
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Atlanta, Georgia, 미국, 30342
- Emory Saint Joseph's Hospital
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Atlanta, Georgia, 미국, 30322
- Winship Cancer Institute
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Atlanta, Georgia, 미국, 30322
- Emory University Clinic
-
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Illinois
-
Chicago, Illinois, 미국, 60612
- University of Illinois Hospital and Health Systems
-
Chicago, Illinois, 미국, 60612
- University of Illinois Hospital and Health Systems (Outpatient Cancer Center)
-
Chicago, Illinois, 미국, 60612
- University of Illinois Hospital and Health Systems (Investigational Drug Pharmacy)
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Kentucky
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Louisville, Kentucky, 미국, 40207
- Norton Cancer Institute, St. Matthews Campus
-
Louisville, Kentucky, 미국, 40207
- Norton Cancer Institute, St Matthews Campus
-
Louisville, Kentucky, 미국, 40241
- Norton Cancer Institute, Brownsboro Hospital Campus
-
Louisville, Kentucky, 미국, 40202
- Norton Cancer Institute, Downtown
-
Louisville, Kentucky, 미국, 40202
- Norton Cancer Institute - Downtown
-
-
Maryland
-
Baltimore, Maryland, 미국, 21202
- Mercy Medical Center
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-
Minnesota
-
Rochester, Minnesota, 미국, 55905
- Mayo Clinic
-
-
Missouri
-
Kansas City, Missouri, 미국, 64111
- Saint Luke's Cancer Institute.
-
-
Nebraska
-
Grand Island, Nebraska, 미국, 68803
- Oncology Hematology West, PC dba Nebraska Cancer Specialists - Grand Island
-
Grand Island, Nebraska, 미국, 68803
- Oncology Hematology West PC dba Nebraska Cancer Specialists
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Omaha, Nebraska, 미국, 68130
- Oncology Hematology West PC dba Nebraska Cancer Specialists
-
Omaha, Nebraska, 미국, 68124
- Oncology Hematology West PC dba Nebraska Cancer Specialists
-
Omaha, Nebraska, 미국, 68114
- Oncology Hematology West PC dba Nebraska Cancer Specialists
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Papillion, Nebraska, 미국, 68046
- Oncology Hematology West PC dba Nebraska Cancer Specialists
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New Jersey
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Jersey City, New Jersey, 미국, 07302
- RWJBarnabas Health- Jersey City Medical Center
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Lakewood, New Jersey, 미국, 08701
- RWJBarnabas Health- Monmouth Medical Center-Southern Campus
-
Livingston, New Jersey, 미국, 07039
- RWJBarnabas Health- Cooperman Barnabas Medical Center
-
Long Branch, New Jersey, 미국, 07740
- RWJBarnabas Health- Monmouth Medical Center
-
New Brunswick, New Jersey, 미국, 08903
- Rutgers Cancer Institute of New Jersey
-
Newark, New Jersey, 미국, 07112
- Newark Beth Israel Medical Center
-
Somerville, New Jersey, 미국, 08876
- Steeplechase Cancer Center
-
Somerville, New Jersey, 미국, 08876
- RWJBarnabas Health-Robert Wood Johnson University Hospital, Somerset
-
Toms River, New Jersey, 미국, 08755
- RWJBarnabas Health - Community Medical Center
-
West Long Branch, New Jersey, 미국, 07764
- Satellite Infusion Center-Monmouth Medical Center Vantage Point Infusion Center
-
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New York
-
The Bronx, New York, 미국, 10461
- Montefiore Einstein Comprehensive Cancer Center
-
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Ohio
-
Cleveland, Ohio, 미국, 44195
- Cleveland Clinic
-
Cleveland, Ohio, 미국, 44106
- Cleveland Clinic Taussig Cancer Center Investigational Pharmacy
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Strongsville, Ohio, 미국, 44136
- Cleveland Clinic Cancer Center - Strongsville
-
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Pennsylvania
-
Willow Grove, Pennsylvania, 미국, 19090
- Asplundh Cancer Pavillion
-
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Tennessee
-
Gallatin, Tennessee, 미국, 37066
- Tennessee Oncology, PLLC
-
Murfreesboro, Tennessee, 미국, 37129
- Tennessee Oncology, PLLC
-
Nashville, Tennessee, 미국, 37203
- Tennessee Oncology, PLLC
-
Nashville, Tennessee, 미국, 37203
- Sarah Cannon Research Institute- Pharmacy
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Shelbyville, Tennessee, 미국, 37160
- Tennessee Oncology, PLLC
-
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Washington
-
Seattle, Washington, 미국, 98195
- University of Washington Medical Center
-
Seattle, Washington, 미국, 98109
- Fred Hutchinson Cancer Center
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Wisconsin
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Milwaukee, Wisconsin, 미국, 53226
- Froedtert Hospital/Medical College of Wisconsin
-
-
-
-
-
Anderlecht, 벨기에, 1070
- Jules Bordet lnstituut
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Brussels, 벨기에, 1090
- Universitair Ziekenhuis Brussel (UZ Brussel)
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Brussels, 벨기에, 1200
- Cliniques Universitaires Saint-Luc
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Ottignies, 벨기에, 1340
- Clinique St-Pierre
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-
-
-
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Porto Alegre/RS, 브라질, 90050-170
- Irmandade da Santa Casa de Misericordia de Porto Alegre centro Multidisciplinar de pesquisa clinica
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São José do Rio Preto, 브라질, 15090-000
- Faculdade Regional de Medicina de Sao Jose do Rio Preto
-
São Paulo, 브라질, 01246-000
- ICESP- Instituto do Cancer do Estado de Sao Paulo Octavio Frias de Oliveira
-
São Paulo, 브라질, 04014-002
- Sao Camilo Oncologia
-
São Paulo, 브라질, CEP: 01317-000
- Clinica de Pesquisas e Centro de Estudos em Oncologia Ginecologica e Mamária Ltda.
-
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Ceará
-
Fortaleza, Ceará, 브라질, 60336-232
- CRIO - Centro Regional lntegrado de Oncologia
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Goiás
-
Goiânia, Goiás, 브라질, 74605-070
- Hospital Araujo Jorge
-
-
Other
-
Sao Paulo/SP, Other, 브라질, 01.509-010
- A.C. Camargo Câncer Center
-
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Paraná
-
Londrina, Paraná, 브라질, 86015-520
- Hospital Do Cancer De Londrina
-
-
Rio Grande do Norte
-
Natal, Rio Grande do Norte, 브라질, 59075-740
- Liga Norte-Rio Grandense Contra o Cancer
-
-
Rio Grande do Sul
-
Porto Alegre, Rio Grande do Sul, 브라질, 90035-903
- Hospital de Clinicas de Porto Alegre
-
Porto Alegre, Rio Grande do Sul, 브라질, CEP 90110-270
- Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa - Hospital do Cancer Mae de Deu
-
Porto Alegre, Rio Grande do Sul, 브라질, CEP 90850-170
- Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa - Hospital do Cancer Mae de Deu
-
-
São Paulo
-
Barretos, São Paulo, 브라질, CEP: 14784-400
- Fundacao Pio XII, Hospital do Amor de Barretos
-
Jaú, São Paulo, 브라질, CEP: 17210-080
- Fundacao Dr Amaral Carvalho
-
Santo André, São Paulo, 브라질, 09060-650
- CEPHO- Centro de Estudos e Pesquisas de Hematologia e Oncologia
-
Santo André, São Paulo, 브라질, 09060-870
- CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
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-
-
-
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Baden, 스위스, 5404
- Kantonsspital Baden.
-
Zurich, 스위스, 8008
- Brust-Zentrum AG
-
-
Canton of Zurich
-
Winterthur, Canton of Zurich, 스위스, 8401
- Kantonsspital Winterthur
-
-
-
-
-
Barcelona, 스페인, 08035
- Hospital Universitari Vall d'Hebron
-
Barcelona, 스페인, 08035
- Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca
-
Barcelona, 스페인, 08025
- Fundacio de Gestio Sanitaria de I'Hospital de la Santa Creu i Sant Pau
-
Barcelona, 스페인, 08041
- Hospital de la Santa Creu i Sant Pau
-
Bilbao, 스페인, 48013
- Hospital Universitario de Basurto
-
Girona, 스페인, 17007
- Institut Catala d'Oncologia Girona - ICO Girona
-
Granada, 스페인, 18014
- Hospital Universitario Virgen de las Nieves
-
Lleida, 스페인, 25198
- Hospital Universitari Arnau de Vilanova
-
Madrid, 스페인, 28007
- Hospital General Universitario Gregorio Maranon
-
Málaga, 스페인, 29010
- Hospital Universitario Virgen de la Victoria
-
Salamanca, 스페인, 37007
- Hospital Universitario de Salamanca (Spain Salamanca)
-
Seville, 스페인, 41013
- Hospital Universitario Virgen del Rocio
-
Valencia, 스페인, 46009
- Fundacion lnstituto Valenciano de Oncologia
-
-
Andalusia
-
Málaga, Andalusia, 스페인, 29016
- Hospital El Angel Grupo Hla, S.L.U
-
-
Balearic Islands
-
Palma de Mallorca, Balearic Islands, 스페인, 07120
- Hospital Universitario Son Espases
-
-
Murcia
-
EI Palmar, Murcia, 스페인, 30120
- Hospital Universitario Virgen De La Arrixaca
-
-
Other
-
Barcelona, Other, 스페인, 08035
- Fundación Privada Instituto de Investigación Oncológica de Vall Hebron
-
Cáceres, Other, 스페인, 10003
- Hospital San Pedro de Alcantara
-
Madrid, Other, 스페인, 28034
- Hospital Universitario Ramon y Cajal
-
Valencia, Other, 스페인, 46010
- Hospital Clinico Universitario de Valencia
-
-
Santa CRUZ DE Tenerife
-
La Laguna Tenerife, Santa CRUZ DE Tenerife, 스페인, 38320
- Hospital Universitario de Canarias
-
-
Valencia
-
Alicante, Valencia, 스페인, 03010
- Hospital General Universitario Alicante
-
-
-
-
-
London, 영국, SW3 6JJ
- The Royal Marsden
-
London, 영국, N12 0JE
- Finchley Memorial Hospital
-
London, 영국, NW1 2PG
- University College London Hospital (UCLH) NHS Foundation Trust
-
Manchester, 영국, M20 4BX
- Christie Hospital NHS Foundation Trust
-
-
England
-
London, England, 영국, NW3 2QG
- Academic Oncology
-
-
Surrey
-
Sutton, Surrey, 영국, SM2 5PT
- The Royal Marsden
-
-
-
-
-
Graz, 오스트리아, A-8010
- Medizinische Universität Graz
-
Graz, 오스트리아, A-8036
- Medizinische Universitat Graz
-
Linz, 오스트리아, A-4010
- Ordensklinikum Linz GmbH Barmherzige Schwestern
-
Vienna, 오스트리아, A-1090
- Medizinische Universitat Wien Universitatsklinik Fur Frauenheilkunde
-
-
Other
-
Schwaz, Other, 오스트리아, A-6130
- Ordination Priv.-Doz. Dr. Michael Hubalek
-
-
-
-
-
Bologna, 이탈리아, 40138
- Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
-
Bologna, 이탈리아, 40138
- SSD Oncologia Medica Addarii - Zamagni, Policlinico Sant'Orsola - Malpighi
-
Milan, 이탈리아, 20089
- Istituto Clinico Humanitas
-
Milan, 이탈리아, 20141
- Divisione di Senologia Medica; Istituto Europeo di Oncologia
-
Parma, 이탈리아, 43126
- UOC di Oncologia Medica, Azienda Ospedaliero Universitaria (AOU) di Parma
-
Pavia, 이탈리아, 27100
- Istituti Clinici Scientifici Maugeri IRCCS
-
-
Campania
-
Naples, Campania, 이탈리아, 80131
- Azienda Ospedaliera Universitaria Federico II
-
Naples, Campania, 이탈리아, 80131
- lstituto Nazionale Tumori IRCCS - Fondazione Pascale U.O.C. Oncologia Medica Senologica
-
-
Liguria
-
Genoa, Liguria, 이탈리아, 16132
- IRCCS Ospedale Policlinico, San Martino
-
-
Lombardy
-
Monza (MB), Lombardy, 이탈리아, 20900
- ASST Monza Ospedale San Gerardo Centro Ricerca di Fase 1
-
-
Sicily
-
Catania (CT), Sicily, 이탈리아, 95045
- Humanitas lstituto Clinico Catanese
-
-
The Marches
-
Torrette, The Marches, 이탈리아, 60126
- Azienda Ospedaliero Universitaria delle Marche SOD Clinica Oncologica
-
-
Trentino-Alto Adige
-
Trento, Trentino-Alto Adige, 이탈리아, 38122
- Divisione Oncologia Medica, Ospedale di Trento - Presidio Ospedaliero (PO) Santa Chiara
-
Trento, Trentino-Alto Adige, 이탈리아, 38122
- SOC Farmacia, Ospedale di Trento - Presidio Ospedaliero (PO)
-
-
Tuscany
-
Livorno, Tuscany, 이탈리아, 57124
- Oncologia Medica Azienda Usl Toscana Nord Ovest - Ospedali Riuniti di Livor
-
Prato, Tuscany, 이탈리아, 59100
- S.O.C. Oncologia Medica - Nuovo Ospedale di Prato Santo Stefano
-
-
-
-
Chiba
-
Kamogawa, Chiba, 일본, 296-8602
- Tesshokai Kameda General Hospital
-
Kashiwa-Shi, Chiba, 일본, 277-8577
- National Cancer Center Hospital East
-
-
Ehime
-
Matsuyama, Ehime, 일본, 791-0280
- NHO Shikoku Cancer Center
-
-
Fukuoka
-
Fukuoka, Fukuoka, 일본, 811-1395
- National Hospital Organization Kyushu Cancer Center
-
-
Fukushima
-
Fukushima, Fukushima, 일본, 960-1295
- Fukushima Medical University Hospital
-
-
Hokkaido
-
Sapporo, Hokkaido, 일본, 003-0804
- National Hospital Organization Hokkaido Cancer Center
-
-
Ibaraki
-
Tsukuba, Ibaraki, 일본, 305-8576
- University of Tsukuba Hospital
-
-
Ishikawa-ken
-
Kanazawa, Ishikawa-ken, 일본, 920-8530
- Ishikawa Prefectural Central Hospital
-
-
Kanagawa
-
Yokohama, Kanagawa, 일본, 241-8515
- Kanagawa Cancer Center
-
-
Okinawa
-
Naha, Okinawa, 일본, 901-0154
- Naha Nishi Clinic
-
-
Osaka
-
Osakasayama-shi, Osaka, 일본, 589-8511
- Kindai University Hospital
-
Sakai, Osaka, 일본, 590-0197
- Kindai University Hospital
-
-
Tokyo
-
Chuo-ku, Tokyo, 일본, 104-0045
- National Cancer Center Hospital
-
Chuo-ku, Tokyo, 일본, 104-8560
- St. Luke's International Hospital.
-
Minato-ku, Tokyo, 일본, 105-8470
- Toranomon Hospital
-
Shinagawa-ku, Tokyo, 일본, 142-8666
- Showa University Hospital
-
-
-
-
-
Beijing, 중국, 100730
- Beijing Hospital
-
Beijing, 중국, 100010
- Beijing Hospital
-
Shanghai, 중국, 200032
- Fudan University Shanghai Cancer Center
-
Tianjin, 중국, 300181
- Tianjin Cancer Hospital Binhai Campus
-
-
Anhui
-
Hefei, Anhui, 중국, 230601
- The Second Hospital of Anhui Medical University
-
-
Guangdong
-
Guangzhou, Guangdong, 중국, 510080
- Guangdong Provincial People's Hospital
-
Meizhou, Guangdong, 중국, 514031
- Meizhou People's Hospital
-
-
Guangxi
-
Liuzhou, Guangxi, 중국, 545006
- Liuzhou People's Hospital
-
Nanning, Guangxi, 중국, 530021
- The People's Hospital of Guangxi Zhuang Autonomous Region
-
Nanning, Guangxi, 중국, 530021
- Guangxi Medical University Affiliated Tumor Hospital
-
-
Hainan
-
Haikou, Hainan, 중국, 570102
- The first Affiliated Hospital of Hainan Medical University
-
-
Hebei
-
Baoding, Hebei, 중국, 071000
- Affiliated Hospital of Hebei University
-
-
Henan
-
Zhengzhou, Henan, 중국, 450003
- Henan Cancer Hospital
-
-
Hubei
-
Wuhan, Hubei, 중국, 430079
- Hubei Cancer Hospital
-
Wuhan, Hubei, 중국, 430030
- Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
-
-
Hunan
-
Changsha, Hunan, 중국, 410011
- The Second Xiangya Hospital of Central South University
-
-
Jiangsu
-
Nanjing, Jiangsu, 중국, 210036
- Nanjing Medical University (NMU) - Jiangsu Province Hospital
-
-
Jiangxi
-
Nanchang, Jiangxi, 중국, 330008
- The Second Affiliated Hospital of Nanchang University
-
-
Jilin
-
Changchun, Jilin, 중국, 130021
- The First Hospital of Jilin University
-
-
Liaoning
-
Shenyang, Liaoning, 중국, 110042
- Liaoning Cancer Hospital & Insitute
-
Shenyang, Liaoning, 중국, 110167
- The First Affiliated Hospital of China Medical University
-
-
Other
-
Shanghai, Other, 중국, 200025
- Ruijin Hospital of Shanghai Jiaotong University School of Medicine
-
-
Shaanxi
-
Xi'an, Shaanxi, 중국, 710061
- The First Affiliated Hospital of Xi'an Jiaotong University
-
Xi'an, Shaanxi, 중국, 710068
- Shaanxi Provincial People's Hospital
-
-
Shandong
-
Jinan, Shandong, 중국, 250013
- Jinan Central Hospital
-
Linyi, Shandong, 중국, 276034
- Linyi Cancer Hospital
-
-
Zhejiang
-
Hangzhou, Zhejiang, 중국, 310016
- Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
-
Hangzhou, Zhejiang, 중국, 310005
- Zhejiang Cancer Hospital
-
Hangzhou, Zhejiang, 중국, 310052
- The Second Affiliated Hospital of Zhejiang University School of Medicine
-
-
-
-
-
Brno, 체코, 656 53
- Masarykuv Onkologicky Ustav
-
Prague, 체코, 128 08
- Vseobecna fakultni nemocnice v Praze
-
Praha 5 - Motol, 체코, 15006
- Nemocnicni lekarna Fakultni nemocnice v Motole
-
Praha 5 - Motol, 체코, 15006
- Fakultni nemocnice v Motole Onkologicka klinika 2. LF UK a FN Motol
-
-
Other
-
Brno, Other, 체코, 656 53
- Ustavni lekarna Masarykuv onkologicky ustav
-
Praha 4 - Krc, Other, 체코, 14059
- Fakultni Thomayerova nemocnice Onkologicka klinika 1. LF UK a FTN
-
-
-
-
-
Talca, 칠레, 3460000
- Clinica Universidad Catolica del Maule
-
Temuco, 칠레, 4810297
- Clinica Alemana Temuco
-
Temuco, 칠레, 4810469
- James Lind Centro De Investigacion Del Cancer
-
-
Santiago Metropolitan
-
Recoleta, Santiago Metropolitan, 칠레, 8420323
- Centro de Investigacion Clínica Bradford Hill
-
-
Valparaiso
-
Viña del Mar, Valparaiso, 칠레
- Oncocentro Apys
-
-
-
-
Alberta
-
Edmonton, Alberta, 캐나다, T6G 1Z2
- Cross Cancer Institute
-
-
British Columbia
-
Kelowna, British Columbia, 캐나다, V1Y 5L3
- BC Cancer Agency
-
-
Ontario
-
Ottawa, Ontario, 캐나다, K1H 8L6
- The Ottawa Hospital Cancer Centre
-
Toronto, Ontario, 캐나다, M5G 1X5
- Mount Sinai Hospital
-
Toronto, Ontario, 캐나다, M4N 3M5
- Sunnybrook Research Institute
-
-
Quebec
-
Chicoutimi, Quebec, 캐나다, G7H 5H6
- Centre integre universitaire de sante et de services sociaux du Saguenay-Lac-Saint-Jean
-
Montreal, Quebec, 캐나다, H3T 1E2
- Jewish General Hospital
-
Montreal, Quebec, 캐나다, H2X 3E4
- Centre Hospitalier de l'Universite de Motreal (CHUM)
-
-
-
-
-
Coimbra, 포르투갈, 3000-075
- Instituto Portugues de Oncologia de Coimbra Francisco Gentil, EPE (IPO, Coimbra)
-
Lisbon, 포르투갈, 1400-038
- Fundacao Champalimaud
-
-
Other
-
Braga, Other, 포르투갈, 4710-243
- Centro Clinico Academico Braga Hospital de Braga
-
Lisbon, Other, 포르투갈, 1998-018
- Hospital CUF Descobertas
-
-
-
-
-
Gdansk, 폴란드, 80-214
- Uniwersyteckie Centrum Kliniczne
-
Lodz, 폴란드, 91-211
- Salve Medica
-
Lodz, 폴란드, 91-211
- Salve Medica Apteka Szpitalna
-
Opole, 폴란드, 45-061
- SP ZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarowskiego w Opolu
-
-
Other
-
Lodz, Other, 폴란드, 93-513
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
-
-
Silesian Voivodeship
-
Gliwice, Silesian Voivodeship, 폴란드, 44-102
- Narodowy lnstytut Onkologii im. Marii Sklodowskiej-Curie-Panstwowy lnstytut Badawczy
-
-
-
-
-
Besançon, 프랑스, 25000
- CHU Besancon
-
Bobigny, 프랑스, 93009 Cedex
- Hopital Avicenne
-
Caen, 프랑스, 14076 Cedex 5
- CENTRE FRANCOIS BACLESSE - Service lmagerie medicale
-
Caen, 프랑스, 14076
- Centre de Lutte contre le Cancer - François Baclesse
-
Caen, 프랑스, 14076 Cedex 5
- Centre Francois Baclesse
-
Clermont-Ferrand, 프랑스, 63000
- Centre Jean Perrin
-
Lille, 프랑스, 59020 Cedex
- Centre Oscar Lambret
-
Lyon, 프랑스, 69373 Cedex 08
- Center Leon Berard
-
Montpellier, 프랑스, 34298 Cedex 5
- Institut Regional du Cancer de Montpellier Service lmagerie medicale
-
Montpellier, 프랑스, 34298
- Institut Régional du Cancer de Montpellier
-
Nice, 프랑스, 06189
- Centre Antoine Lacassagne
-
Pierre-Bénite, 프랑스, 69310
- Hospices Civils de Lyon
-
Plérin, 프랑스, 22190
- "CARIO - Centre Armoricain de Radiotherapie lmagerie medicate et d'Oncologie -Hopital Prive des
-
Rennes, 프랑스, cedex 35042
- Centre Eugene Marquis
-
Rouen, 프랑스, 76038 Cedex 1
- Centre Henri Becquerel
-
Saint-Cloud, 프랑스, 92210
- Institut Curie - site St-Cloud
-
Strasbourg, 프랑스, 67033
- Institut de Cancerologie Strasbourg Europe
-
-
Brittany Region
-
Rouen, Brittany Region, 프랑스, 76038
- Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer
-
-
Cedex
-
Bordeaux, Cedex, 프랑스, 33076
- Institut Bergonie
-
-
Languedoc-roussillon
-
Montpellier, Languedoc-roussillon, 프랑스, 34070
- Centre de Cancérologie du Grand Montpellier
-
-
Loire-atlantique
-
Saint-Herblain, Loire-atlantique, 프랑스, 44800
- Institut de Cancerologie de lOuest - Site Rene Gauducheau
-
Saint-Herblain, Loire-atlantique, 프랑스, 44805
- Institut de Cancerologie de lOuest-Saint Herblain
-
-
Other
-
Avignon, Other, 프랑스, 84918
- Institut Sainte-Catherine.
-
Avignon, Other, 프랑스, 84918
- Sainte Catherine lnstitut du Cancer Avignon Provence
-
Dijon, Other, 프랑스, 21079
- Center Georges-Francois Leclerc
-
-
-
-
-
Tampere, 핀란드
- Tampere University Hospital
-
Tampere, 핀란드, 33520
- Tampere University Hospital, FONK/RSYO
-
-
-
-
New South Wales
-
Camperdown, New South Wales, 호주, 2050
- Chris O'Brien Lifehouse
-
Macquarie University, New South Wales, 호주, 2109
- Macquarie University Clinical Trials Unit.
-
Westmead, New South Wales, 호주, 2145
- Western Sydney Local Health District (WSLHD), Westmead Hospital
-
-
South Australia
-
Adelaide, South Australia, 호주, 5000
- Cancer Research SA
-
Adelaide, South Australia, 호주, 5000
- St Andrews Medical Centre
-
Bedford Park, South Australia, 호주, 5042
- Flinders Medical Centre
-
-
Victoria
-
Box Hill, Victoria, 호주, 3128
- Box Hill Hospital
-
Heidelberg, Victoria, 호주, 3084
- Austin Health
-
-
Washington
-
Subiaco, Washington, 호주, 6008
- St John of God Subiaco Hospital Clinical Trials Unit Bendat Family Comprehensive Cancer Centre
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
-
Centrally confirmed HER2+ breast carcinoma according to the 2018 American Society of Clinical Oncologists (ASCO) College of American Pathologists (CAP) guidelines prior to randomization (defined as a 3+ score on immunohistochemistry (IHC) and/or 2+ IHC and concurrent positive by ISH).
-
Have unresectable locally advanced or metastatic disease.
- If recurrent (after [neo]adjuvant therapy), must be at least 6 month treatment free from any trastuzumab and pertuzumab received in the early breast cancer setting for advanced HER2+ disease.
-
Have received 4-8 cycles of pre-study induction therapy including only trastuzumab, pertuzumab, and taxane as first-line of therapy for the treatment of advanced breast cancer prior to study enrollment. Participants are eligible provided they are without evidence of disease progression following completion of induction therapy.
-
Known hormone receptor status (per local guidelines; may be hormone receptor positive [HR+] or negative [HR-])
-
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
-
CNS Inclusion - Based on screening contrast-enhanced brain magnetic resonance imaging (MRI), participants may have any of the following:
-
No evidence of brain metastases
-
Untreated brain metastases which are asymptomatic not needing immediate local treatment and, if identified on prior brain imaging, without evidence of progression since starting first-line induction therapy with trastuzumab, pertuzumab, and taxane
-
Previously treated brain metastases which are asymptomatic
- Brain metastases previously treated with local therapy must not have progressed since treatment
-
Exclusion Criteria:
-
Prior treatment with any tyrosine kinase inhibitor targeting HER2 and/or epidermal growth factor receptor (EGFR) including pyrotinib, lapatinib, tucatinib, neratinib, and afatinib (except neratinib if given in extended adjuvant setting and ≥ 12 months have elapsed since last neratinib dose prior to start of study drug)
-
Unable to undergo contrast-enhanced MRI of the brain
-
CNS Exclusion - Based on screening brain MRI and clinical assessment
- Symptomatic brain metastasis after CNS-directed local therapy
- Progression of brain metastases since starting first line trastuzumab, pertuzumab, and taxane
- Ongoing use of systemic corticosteroids at a total daily dose of >2 mg of dexamethasone (or equivalent)
- Any untreated brain lesion in an anatomic site which may pose risk to participant
- Known or suspected leptomeningeal disease (LMD)
- Poorly controlled (>1/week) seizures, or other persistent neurologic symptoms
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Tucatinib + trastuzumab + pertuzumab
Tucatinib + trastuzumab + pertuzumab |
300mg given by mouth (orally) twice daily
다른 이름들:
6mg/kg given into the vein (IV; intravenously) or 600mg injected under the skin (SC; subcutaneous) every 21 days
다른 이름들:
420mg given by IV every 21 days
다른 이름들:
600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase will be given by subcutaneous injection every 21 days. May be given in place of trastuzumab and pertuzumab individually.
다른 이름들:
|
|
활성 비교기: Placebo + trastuzumab + pertuzumab
Placebo + trastuzumab + pertuzumab |
6mg/kg given into the vein (IV; intravenously) or 600mg injected under the skin (SC; subcutaneous) every 21 days
다른 이름들:
420mg given by IV every 21 days
다른 이름들:
600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase will be given by subcutaneous injection every 21 days. May be given in place of trastuzumab and pertuzumab individually.
다른 이름들:
Given orally twice daily |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Progression-Free Survival (PFS) as Assessed by Investigator Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1
기간: From randomization until the first documentation of PD or death from any cause or censoring date, whichever occurred first (maximum treatment exposure was of 41.3 months)
|
PFS: time from randomization to the first documented disease progression (PD) (as assessed by investigator per RECIST 1.1) or death from any cause, whichever occurred first. PD: >=20% increase in sum of diameters of target lesions, taking as reference the smallest sum of diameter recorded since the treatment started or the appearance of 1 or more new lesions. Participants without documentation of PD/ death at the time of analysis, were censored at date of last tumor assessment with an overall response of complete response (CR), partial response (PR), stable disease (SD), non-CR/non-PD or no evidence of disease (NED). CR: disappearance of all target lesions; PR: >=30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameter since the treatment started. Kaplan-Meier method was used for analysis. |
From randomization until the first documentation of PD or death from any cause or censoring date, whichever occurred first (maximum treatment exposure was of 41.3 months)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Overall Survival (OS)
기간: From the date of randomization until date of death or censoring date (approximately 66.7 months)
|
OS: time from randomization to death due to any cause. For a participant who would not known to have died by the end of study follow-up, observation of OS would be censored on the date the participant was last known to be alive (i.e., the date of last contact). |
From the date of randomization until date of death or censoring date (approximately 66.7 months)
|
|
PFS as Assessed by Blinded Independent Central Review (BICR) Per RECIST v1.1
기간: From randomization until the first documentation of PD or death from any cause or censoring date, whichever occurred first (maximum treatment exposure was of 41.3 months)
|
PFS per BICR was defined as the time from the date of randomization to the documented disease progression assessed by BICR according to RECIST v1.1 or death from any cause, whichever occurred first. As per RECIST v1.1, PD: >=20% increase in sum of diameter of target lesions, taking as reference the smallest sum of diameters recorded since treatment started or appearance of 1 or more new lesions, unequivocal progression of existing non-target lesions. Participants without documentation of PD/ death were censored at date of last tumor assessment with an overall response of CR, PR, SD, non-CR/non-PD or NED. CR: disappearance of all target lesions; PR: >=30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameter since the treatment started. Kaplan-Meier method was used for analysis. |
From randomization until the first documentation of PD or death from any cause or censoring date, whichever occurred first (maximum treatment exposure was of 41.3 months)
|
|
Time to Deterioration (TTD) of Health-Related Quality of Life (HRQoL)
기간: Approximately 66.7 months
|
Time to deterioration of HRQoL was defined as time to 10-point decrease in the global health status/QoL scale of the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ-C30). EORTC QLQ-C30 is 30 item questionnaires composed of 5 multi-item functional domains (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, nausea, and vomiting) and 6 single items for symptoms (shortness of breath, loss of appetite, sleep disturbance, constipation, diarrhea and financial impact of the disease), 2 global items (health, overall QoL). Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms. |
Approximately 66.7 months
|
|
Central Nervous System (CNS) PFS as Assessed by Investigator Per RECIST v1.1
기간: From randomization until the first documentation of PD or death from any cause or censoring date, whichever occurred first (maximum treatment exposure was of 41.3 months)
|
CNS-PFS was defined as the time from randomization to investigator assessed disease progression in brain according to RECIST v1.1, or death from any cause, whichever occurred first. As per RECIST v1.1, PD: >= 20% increase in sum of diameter of target lesions, taking as reference the smallest sum of diameters recorded since the treatment started or appearance of 1 or more new lesions, unequivocal progression of existing non-target lesions. Participants without documentation of PD/ death at the time of analysis were censored at date of last tumor assessment with an overall response of CR, PR, SD, non-CR/non-PD or NED. CR: disappearance of all target lesions; PR: >=30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameter since the treatment started. Kaplan-Meier method was used for analysis. |
From randomization until the first documentation of PD or death from any cause or censoring date, whichever occurred first (maximum treatment exposure was of 41.3 months)
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
기간: From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to 42.3 months)
|
An adverse event (AE) was any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which did not necessarily had a causal relationship with this treatment. TEAEs were defined as events that were new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of study treatment. AEs included both Serious AE (SAEs) and all other AEs. An AE should be classified as a serious SAE if it meets one of the following criteria: fatal, life threatening, requires or prolongs hospitalization, disabling/ incapacitating, congenital anomaly or birth defect, medically significant. |
From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to 42.3 months)
|
|
Number of Participants With Treatment Emergent Laboratory Abnormalities
기간: From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to 66.7 months)
|
TEAEs were defined as events that were new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of study treatment. Treatment emergent laboratory abnormalities include: hematology (hemoglobin decreased, hemoglobin increased, leukocytes decreased, neutrophils decreased, platelets decreased); chemistry (alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, creatinine increased, potassium decreased, potassium increased, sodium decreased, sodium increased, total bilirubin increased). |
From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to 66.7 months)
|
|
Number of Participants With TEAEs Leading to Dose Discontinuations
기간: From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to 66.7 months)
|
TEAEs were defined as events that were new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of study treatment. In this outcome measure, number of participants with TEAEs leading to dose discontinuations with study treatment will be reported. |
From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to 66.7 months)
|
|
Number of Participants With TEAEs Leading to Dose Hold
기간: From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to 66.7 months)
|
TEAEs were defined as events that were new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of study treatment. In this outcome measure, number of participants with TEAEs leading to dose hold with study treatment will be reported. Dose hold requirements are defined per protocol. |
From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to 66.7 months)
|
|
Number of Participants With TEAEs Leading to Dose Reductions
기간: From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to 66.7 months)
|
TEAEs were defined as events that were new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of study treatment. In this outcome measure, number of participants with TEAEs leading to dose reductions with tucatinib, trastuzumab and pertuzumab are reported. Dose reduction requirements are defined per protocol. |
From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to 66.7 months)
|
|
Trough Concentration (Ctrough) of Tucatinib
기간: Pre-dose on Day 1 of Cycles 2, 3, 4, 5 and 6
|
Concentration at Trough was defined as predose/trough concentration observed directly from data. |
Pre-dose on Day 1 of Cycles 2, 3, 4, 5 and 6
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of Participants With TEAEs: Through Study Completion
기간: From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to 66.7 months)
|
An AE was any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which did not necessarily had a causal relationship with this treatment. TEAEs were defined as events that were new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of study treatment. AEs included both SAEs and all other AEs. An AE should be classified as a serious SAE if it meets one of the following criteria: fatal, life threatening, requires or prolongs hospitalization, disabling/ incapacitating, congenital anomaly or birth defect, medically significant. |
From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to 66.7 months)
|
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수사관
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추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- SGNTUC-028
- C4251007 (기타 식별자: Alias Study Number)
- 2023-503826-37-00 (레지스트리 식별자: CTIS (EU))
- 2023 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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