Spots Global Cancer Trial Database for Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC) (MK-3475-522/KEYNOTE-522)
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Trial Identification
Brief Title: Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC) (MK-3475-522/KEYNOTE-522)
Official Title: A Phase III, Randomized, Double-blind Study to Evaluate Pembrolizumab Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy for Triple Negative Breast Cancer (TNBC)
Study ID: NCT03036488
Conditions
Study Description
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of pembrolizumab (MK-3475) plus chemotherapy vs placebo plus chemotherapy as neoadjuvant therapy and pembrolizumab vs placebo as adjuvant therapy in participants who have triple negative breast cancer (TNBC). After a screening phase of approximately 28 days, each participant will receive neoadjuvant study treatment (Pembrolizumab + Chemotherapy OR Placebo + Chemotherapy) based on the randomization schedule for approximately 24 weeks (8 cycles). Each participant will then undergo definitive surgery 3-6 weeks after conclusion of the last cycle of the neoadjuvant study treatment. After definitive surgery, each participant will receive adjuvant study treatment (Pembrolizumab OR Placebo) for approximately 27 weeks (9 cycles). Following adjuvant study treatment, each participant will be monitored for safety, survival and disease recurrence. The primary study hypothesis is that pembrolizumab is superior to placebo, in combination with chemotherapy, as measured by the rate of Pathological Complete Response (pCR) and/or Event-free Survival (EFS), in participants with locally advanced TNBC.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Virginia G. Piper Cancer Center Pharmacy - Scottsdale Healthcare ( Site 0089), Scottsdale, Arizona, United States
Arizona Oncology Associates PC- HOPE ( Site 8001), Tucson, Arizona, United States
Cedars Sinai Medical Center ( Site 0091), Los Angeles, California, United States
Pacific Cancer Care ( Site 0069), Monterey, California, United States
ICRI ( Site 0072), Whittier, California, United States
University of Colorado Cancer Center ( Site 0021), Aurora, Colorado, United States
Yale University School of Medicine ( Site 0054), New Haven, Connecticut, United States
Christiana Hospital ( Site 0029), Newark, Delaware, United States
Univ of Miami-Sylvester Comprehensive Cancer Center- Kendall satellite ( Site 0079), Miami, Florida, United States
The University of Chicago Medical Center ( Site 0047), Chicago, Illinois, United States
North Shore University Health System ( Site 0081), Evanston, Illinois, United States
Orchard Healthcare Research Inc. ( Site 0049), Skokie, Illinois, United States
Goshen Center for Cancer Care ( Site 0010), Goshen, Indiana, United States
University of Iowa Hospital and Clinics ( Site 0038), Iowa City, Iowa, United States
New England Cancer Specialists ( Site 0005), Scarborough, Maine, United States
Henry Ford Hospital ( Site 0003), Detroit, Michigan, United States
Minnesota Oncology Hematology, PA ( Site 8013), Minneapolis, Minnesota, United States
Rutgers Cancer Institute of New Jersey ( Site 0073), New Brunswick, New Jersey, United States
Broome Oncology, LLC ( Site 8002), Johnson City, New York, United States
Nyack Hospital Infusion Center ( Site 0059), Nyack, New York, United States
TriHealth Cancer Institute-Good Samaritan Hospital ( Site 0044), Cincinnati, Ohio, United States
Oncology Hematology Care, Inc. ( Site 8011), Cincinnati, Ohio, United States
Providence Portland Medical Center ( Site 0052), Portland, Oregon, United States
Northwest Cancer Specialists, P.C. ( Site 8008), Portland, Oregon, United States
Magee - Women's Hospital ( Site 0011), Pittsburgh, Pennsylvania, United States
Rhode Island Hospital ( Site 0060), Providence, Rhode Island, United States
The West Clinic, P.C. ( Site 0078), Germantown, Tennessee, United States
Texas Oncology-Austin Central ( Site 8005), Austin, Texas, United States
Parkland Health and Hospital System ( Site 0093), Dallas, Texas, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center ( Site 8006), Dallas, Texas, United States
Simmons Cancer Center ( Site 0094), Dallas, Texas, United States
UT Southwestern Medical Center ( Site 0030), Dallas, Texas, United States
Moncrief Cancer Institute ( Site 0092), Fort Worth, Texas, United States
Texas Oncology-Memorial City ( Site 8003), Houston, Texas, United States
Houston Methodist Cancer Center ( Site 0013), Houston, Texas, United States
Texas Oncology- Plano East ( Site 8010), Plano, Texas, United States
Texas Oncology-San Antonio Northeast ( Site 8012), San Antonio, Texas, United States
Texas Oncology-Tyler ( Site 8007), Tyler, Texas, United States
University of Virginia ( Site 0022), Charlottesville, Virginia, United States
Virginia Cancer Specialists, PC ( Site 8009), Fairfax, Virginia, United States
Bon Secours Cancer Institute Medical Oncology at St. Mary's ( Site 0033), Midlothian, Virginia, United States
Peninsula Cancer Institute, LLC ( Site 0041), Newport News, Virginia, United States
Virginia Oncology Associates ( Site 8000), Norfolk, Virginia, United States
Kadlec Clinic Hematology and Oncology ( Site 0087), Kennewick, Washington, United States
Seattle Cancer Care Alliance ( Site 0068), Seattle, Washington, United States
Medical Oncology Associates (Summit Cancer Centers) ( Site 0014), Spokane, Washington, United States
YVMH dba Vrigina Mason Memorial/North Star Lodge Cancer Center ( Site 8004), Yakima, Washington, United States
Royal North Shore Hospital ( Site 2000), Sydney, New South Wales, Australia
Westmead Hospital ( Site 2002), Sydney, New South Wales, Australia
Royal Adelaide Hospital ( Site 2008), Adelaide, South Australia, Australia
Cabrini Health ( Site 2009), East Malvern, Victoria, Australia
Frankston Hospital ( Site 2010), Franskton, , Australia
Royal Brisbane and Women s Hospital ( Site 2003), Herston, , Australia
St John of God Subiaco Hospital ( Site 2006), Perth, , Australia
Hospital Nossa Senhora da Conceicao ( Site 0203), Porto Alegre, Rio Grande Do Sul, Brazil
UOPECCAN - Uniao Oeste Paranaense de Estudos e Combate ao Cancer ( Site 0206), Cascavel, , Brazil
Universidade de Caxias do Sul ( Site 0201), Caxias do Sul, , Brazil
Hospital Erasto Gaertner ( Site 0207), Curitiba, , Brazil
Instituto do Cancer do Ceara ( Site 0205), Fortaleza, , Brazil
Hospital Araujo Jorge ( Site 0204), Goiania, , Brazil
Hospital Sao Lucas da PUCRS ( Site 0200), Porto Alegre, , Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto ( Site 0208), Sao Jose do Rio Preto, , Brazil
Instituto do Cancer de Sao Paulo - ICESP ( Site 0211), Sao Paulo, , Brazil
Tom Baker Cancer Centre ( Site 0105), Calgary, Alberta, Canada
The Ottawa Hospital - Cancer Care ( Site 0100), Ottawa, Ontario, Canada
Princess Margaret Cancer Centre ( Site 0103), Toronto, Ontario, Canada
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0106), Montreal, Quebec, Canada
Jewish General Hospital ( Site 0101), Montreal, Quebec, Canada
CIUSSS de l'Estrie-CHUS ( Site 0102), Sherbrooke, Quebec, Canada
CHU de Quebec Universite Laval - Hopital du Saint-Sacrement ( Site 0104), Quebec, , Canada
Oncomedica S.A. ( Site 0404), Monteria, Cordoba, Colombia
Oncologos del Occidente S.A. ( Site 0405), Pereira, Risaralda, Colombia
Hospital Universitario San Ignacio ( Site 0401), Bogota, , Colombia
Instituto Nacional de Cancerologia [Bogota-Colombia] ( Site 0403), Bogota, , Colombia
Hemato Oncologos S.A. ( Site 0400), Cali, , Colombia
Instituto De Cancerologia S.A. ( Site 0406), Medellin, , Colombia
CHU Jean Minjoz ( Site 0917), Besancon, , France
Polyclinique Bordeaux Nord Aquitaine ( Site 0911), Bordeaux, , France
Centre Francois Baclesse ( Site 0907), Caen, , France
Centre Jean Perrin ( Site 0903), Clermont-Ferrand Cedex 01, , France
Clinique Victor Hugo ( Site 0901), Le Mans, , France
Hopital prive du Confluent ( Site 0902), Nantes, , France
Institut Curie ( Site 0909), Paris, , France
Hopital Saint Louis ( Site 0908), Paris, , France
Hopital Diaconesses Croix Saint Simon ( Site 0905), Paris, , France
CHU de la Miletrie Poitiers ( Site 0913), Poitiers, , France
Institut Claudius Regaud IUCT Oncopole ( Site 0914), Toulouse Cedex 9, , France
HELIOS Klinikum Berlin-Buch ( Site 1005), Berlin, , Germany
Gynaekologisches Zentrum ( Site 1004), Bonn, , Germany
Universitaetsklinikum Erlangen ( Site 1001), Erlangen, , Germany
Kliniken Essen Mitte ( Site 1012), Essen, , Germany
Universitaetsklinik und Poliklinik Halle/Saale ( Site 1008), Halle, , Germany
Universitaetsklinikum Hamburg-Eppendorf ( Site 1007), Hamburg, , Germany
Klinikum der Universit. Muenchen ( Site 1002), Muenchen, , Germany
Caritasklinik St. Theresia ( Site 1011), Saarbruecken, , Germany
Universitaets-Frauenklinik Tuebingen ( Site 1003), Tubingen, , Germany
Bon Secours Hospital ( Site 1551), Cork, , Ireland
St Vincents University Hospital ( Site 1550), Dublin, , Ireland
Oncology institute ( Site 1601), Beer Sheva, , Israel
Assaf Harofeh MC ( Site 1605), Beer Yaakov-Zerifin, , Israel
Hadassah Ein Karem - Sharett Institute of Oncology ( Site 1600), Jerusalem, , Israel
Rabin-Medical Center ( Site 1604), Petah Tikva, , Israel
Sheba Medical Center ( Site 1602), Ramat-Gan, , Israel
Sourasky Medical Center ( Site 1603), Tel Aviv, , Israel
Istituto Scientifico Romagnolo per Studio e Cura Tumori IRST ( Site 1101), Meldola, FC, Italy
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia ( Site 1103), Brescia, , Italy
Ospedale San Luca, AZIENDA USL2 TOSCANA NORD OVEST ( Site 1105), Lucca, , Italy
Ospedale Civile di Macerata ( Site 1104), Macerata, , Italy
Istituto Europeo di Oncologia ( Site 1106), Milano, , Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1102), Napoli, , Italy
Aichi Cancer Center Hospital ( Site 2502), Nagoya, Aichi, Japan
National Cancer Center Hospital East ( Site 2518), Kashiwa, Chiba, Japan
National Hospital Organization Hokkaido Cancer Center ( Site 2512), Sapporo, Hokkaido, Japan
Hyogo College of Medicine Hospital ( Site 2506), Nishinomiya, Hyogo, Japan
Tokai University Hospital ( Site 2517), Isehara, Kanagawa, Japan
St. Marianna University School of Medicine Hospital ( Site 2516), Kawasaki, Kanagawa, Japan
Kindai University Hospital ( Site 2507), Osakasayama, Osaka, Japan
Saitama Medical University International Medical Center ( Site 2513), Hidaka, Saitama, Japan
Saitama Cancer Center ( Site 2510), Kitaadachi-gun, Saitama, Japan
Shizuoka Cancer Center Hospital and Research Institute ( Site 2514), Sunto-gun, Shizuoka, Japan
Chiba Cancer Center ( Site 2519), Chiba, , Japan
Hiroshima City Hiroshima Citizens Hospital ( Site 2501), Hiroshima, , Japan
Social medical corporation Hakuaikai Sagara Hospital ( Site 2508), Kagoshima, , Japan
Kumamoto University Hospital ( Site 2515), Kumamoto, , Japan
National Hospital Organization Osaka National Hospital ( Site 2505), Osaka, , Japan
National Cancer Center Hospital ( Site 2500), Tokyo, , Japan
St.Luke's International Hospital ( Site 2511), Tokyo, , Japan
Toranomon Hospital ( Site 2503), Tokyo, , Japan
The Cancer Institute Hospital of JFCR ( Site 2509), Tokyo, , Japan
Seoul National University Hospital ( Site 2101), Seoul, , Korea, Republic of
Severance Hospital Yonsei University Health System ( Site 2100), Seoul, , Korea, Republic of
Asan Medical Center ( Site 2102), Seoul, , Korea, Republic of
Samsung Medical Center ( Site 2103), Seoul, , Korea, Republic of
Mazowiecki Szpital Onkologiczny ( Site 1713), Wieliszew, Mazowieckie, Poland
Centrum Onkologii Instytut im. Marii Skłodowskiej Curie ( Site 1717), Gliwice, Slaskie, Poland
Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 1708), Bydgoszcz, , Poland
Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 1712), Bydgoszcz, , Poland
Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 1701), Gdynia, , Poland
Centrum Onkologii Instytut im. Marii Sklodowskiej Curie ( Site 1719), Krakow, , Poland
Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli ( Site 1700), Lublin, , Poland
Dolnoslaskie Centrum Onkologii. ( Site 1702), Wroclaw, , Poland
Fundacao Champalimaud ( Site 2444), Lisboa, , Portugal
Hospital de Santa Maria, E.P.E. ( Site 2445), Lisboa, , Portugal
Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E. ( Site 2446), Porto, , Portugal
Arkhangelsk Clinical Oncological Dispensary ( Site 1810), Arkhangelsk, , Russian Federation
Chelyabinsk Regional Clinical Oncological Dispensary ( Site 1805), Chelyabinsk, , Russian Federation
Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1806), Kazan, , Russian Federation
Russian Oncological Research Center n.a. N.N.Blokhin of MoH ( Site 1801), Moscow, , Russian Federation
GBU RO Regional Clinical Oncological Dispensary ( Site 1808), Ryazan, , Russian Federation
Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1803), Saint Petersburg, , Russian Federation
Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1804), Ufa, , Russian Federation
National Cancer Centre Singapore ( Site 2600), Singapore, , Singapore
ICO L Hospitalet ( Site 1305), Hospitalet de Llobregat, Barcelona, Spain
Hospital Quiron de Madrid ( Site 1303), Pozuelo de Alarcon, Madrid, Spain
Hospital del Mar ( Site 1306), Barcelona, , Spain
Instituto Oncologico Baselga.Hospital Quiron. ( Site 1312), Barcelona, , Spain
Hospital General Universitari Vall d Hebron ( Site 1301), Barcelona, , Spain
Hospital Universitario Reina Sofia ( Site 1304), Cordoba, , Spain
Hospital Universitario Ramon y Cajal ( Site 1300), Madrid, , Spain
Complejo Hospitalario Universitario de Santiago ( Site 1308), Santiago de Compostela, , Spain
Hospital Universitario Virgen del Rocio ( Site 1314), Sevilla, , Spain
Hospital Clinico Univ de Valencia ( Site 1313), Valencia, , Spain
Linkopings Universitetssjukhus ( Site 1402), Linkoping, , Sweden
Karolinska Universitetssjukhuset Solna ( Site 1404), Solna, , Sweden
Norrlands Universitetssjukhus ( Site 1401), Umea, , Sweden
Akademiska Sjukhuset ( Site 1403), Uppsala, , Sweden
Taipei Veterans General Hospital ( Site 2302), Taipei, Beitou, Taiwan
National Cheng Kung University Hospital ( Site 2305), Tainan, , Taiwan
National Taiwan University Hospital ( Site 2301), Taipei, , Taiwan
MacKay Memorial Hospital ( Site 2303), Taipei, , Taiwan
Koo Foundation Sun Yat-Sen Cancer Center ( Site 2304), Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital ( Site 2300), Taoyuan, , Taiwan
Samsun Ondokuz Mayıs Universitesi Tıp Fakultesi Hastanesi ( Site 1910), Samsun, Atakum, Turkey
Adana Acıbadem Hospital Department of Medical Oncology ( Site 1906), Adana, , Turkey
Baskent Unıversity Adana Kısla Hospital ( Site 1903), Adana, , Turkey
Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1912), Ankara, , Turkey
Abdurrahman Yurtaslan Oncology Training and Research Hospital ( Site 1909), Ankara, , Turkey
Ozel Medicana International Ankara Hastanesi ( Site 1915), Ankara, , Turkey
Antalya Memorial Hospital Department of Medical Oncology ( Site 1908), Antalya, , Turkey
Trakya University Medical Faculty Balkan Oncology Hospital ( Site 1901), Edirne, , Turkey
Acibadem Altunizade Hastanesi ( Site 1900), Istambul, , Turkey
İstanbul University Cerrahpaşa Medical Faculty ( Site 1904), Istanbul, , Turkey
Amerikan Hospital Medical ( Site 1902), Istanbul, , Turkey
Memorial Sisli Hastanesi ( Site 1913), Istanbul, , Turkey
Ege University Medical Faculty Tulay Aktas Oncology Hospital ( Site 1905), Izmir, , Turkey
Izmir Medical Park Hospital Department of Medical Oncology ( Site 1907), Izmir, , Turkey
Colchester General Hospital ( Site 1508), Colchester, Essex, United Kingdom
Barts Cancer Institute ( Site 1500), London, , United Kingdom
St George s Hospital ( Site 1516), London, , United Kingdom
Maidstone Hospital ( Site 1511), Maidstone, , United Kingdom
The James Cook University Hospital ( Site 1515), Middlesbrough, , United Kingdom
Nottingham University Hospitals NHS Trust ( Site 1505), Nottingham, , United Kingdom
Royal Cornwall Hospitals NHS Trust ( Site 1504), Truro, , United Kingdom
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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