Study of Pembrolizumab (MK-3475) Versus Placebo in Combination With Neoadjuvant Chemotherapy & Adjuvant Endocrine Therapy in the Treatment of Early-Stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer (MK-3475-756/KEYNOTE-756)
研究单位：[1]Merck Sharp & Dohme LLC[2]Cancer Treatment Centers of America at Western Regional Medical Center ( Site 0001) Goodyear, Arizona, United States, 85338[3]Arizona Oncology Associates PC- HOPE ( Site 8008) Tucson, Arizona, United States, 85704[4]Cedars Sinai Medical Center Samuel Oschin Comp. Cancer Institute ( Site 0079) Los Angeles, California, United States, 90048[5]El Camino Hospital Cancer Center ( Site 0004) Mountain View, California, United States, 94040[6]Stanford Cancer Center ( Site 0072) Palo Alto, California, United States, 94304[7]UC Davis Comprehensive Cancer Center ( Site 0073) Sacramento, California, United States, 95817[8]University of Colorado Cancer Center ( Site 0008) Aurora, Colorado, United States, 80045[9]Baptist MD Anderson Cancer Center ( Site 0014) Jacksonville, Florida, United States, 32207[10]Southeastern Regional Medical Center, Inc. ( Site 0075) Newnan, Georgia, United States, 30265[11]The University of Chicago Medical Center ( Site 0080) Chicago, Illinois, United States, 60637[12]Orchard Healthcare Research Inc. ( Site 0020) Skokie, Illinois, United States, 60077[13]Midwestern Regional Medical Center, Inc. ( Site 0077) Zion, Illinois, United States, 60099[14]Goshen Center for Cancer Care ( Site 0021) Goshen, Indiana, United States, 46526[15]MercyOne Waterloo Cancer Center ( Site 0016) Waterloo, Iowa, United States, 50702[16]James Graham Brown Cancer Center ( Site 0022) Louisville, Kentucky, United States, 40202[17]Maryland Oncology Hematology, P.A. ( Site 8007) Bethesda, Maryland, United States, 20817[18]Massachusetts General Hospital ( Site 0024) Boston, Massachusetts, United States, 02114[19]MGH - North Shore Cancer Center ( Site 0081) Danvers, Massachusetts, United States, 01923[20]MGH Newton-Wellesley Hospital's Vernon Cancer Center ( Site 0082) Newton, Massachusetts, United States, 02462[21]Henry Ford Health System ( Site 0028) Detroit, Michigan, United States, 48202[22]Mayo Clinic and Medical School (Rochester) ( Site 0029) Rochester, Minnesota, United States, 55905[23]St. Vincent Frontier Cancer Center ( Site 0033) Billings, Montana, United States, 59102[24]Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0039) Omaha, Nebraska, United States, 68130[25]Holy Name Medical Center ( Site 0041) Teaneck, New Jersey, United States, 07666[26]Weill Cornell Medical College ( Site 0043) New York, New York, United States, 10065[27]CTCA Southwestern ( Site 0074) Tulsa, Oklahoma, United States, 74133[28]OHSU Knight Cancer Institute ( Site 0051) Portland, Oregon, United States, 97239[29]Northwest Cancer Specialists, P.C. ( Site 8000) Tigard, Oregon, United States, 97223[30]Geisinger Medical Center ( Site 0052) Danville, Pennsylvania, United States, 17822[31]Fox Chase Cancer Center ( Site 0078) Philadelphia, Pennsylvania, United States, 19111[32]Cancer Treatment Centers of America-Eastern Regional Medical Center ( Site 0076) Philadelphia, Pennsylvania, United States, 19124[33]Medical University of South Carolina ( Site 0053) Charleston, South Carolina, United States, 29425[34]Tennessee Oncology, PLLC/The Sarah Cannon Research Institute ( Site 7000) Nashville, Tennessee, United States, 37203[35]Texas Oncology-Austin Central ( Site 8004) Austin, Texas, United States, 78731[36]Texas Oncology-Dallas Presbyterian Hospital ( Site 8002) Dallas, Texas, United States, 75231[37]Texas Oncology-Baylor Charles A. Sammons Cancer Center ( Site 8009) Dallas, Texas, United States, 75246[38]Texas Oncology-Memorial City ( Site 8012) Houston, Texas, United States, 77024[39]University of Texas-MD Anderson Cancer Center ( Site 0083) Houston, Texas, United States, 77030-4009[40]Texas Oncology- Plano East ( Site 8010) Plano, Texas, United States, 75075[41]Texas Oncology-Tyler ( Site 8006) Tyler, Texas, United States, 75702[42]Bon Secours St. Francis Medical Center Oncology Research ( Site 0064) Midlothian, Virginia, United States, 23114[43]Virginia Oncology Associates ( Site 8001) Norfolk, Virginia, United States, 23502[44]Kadlec Clinic Hematology and Oncology ( Site 0070) Kennewick, Washington, United States, 99336[45]Medical Oncology Associates (Summit Cancer Centers) ( Site 0066) Spokane, Washington, United States, 99208[46]Chris OBrien Lifehouse ( Site 2107) Camperdown, New South Wales, Australia, 2050[47]Royal North Shore Hospital ( Site 2100) Sydney, New South Wales, Australia, 2065[48]Westmead Hospital ( Site 2101) Sydney, New South Wales, Australia, 2145[49]Mater Misericordiae Ltd ( Site 2106) South Brisbane, Queensland, Australia, 4101[50]Frankston Hospital ( Site 2103) Frankston, Victoria, Australia, 3199[51]Peter MacCallum Cancer Centre ( Site 2102) Melbourne, Victoria, Australia, 3000[52]Imelda Ziekenhuis Bonheiden ( Site 0703) Bonheiden, Antwerpen, Belgium, 2820[53]UZ Antwerpen - Medical Oncology ( Site 0709) Edegem, Antwerpen, Belgium, 2650[54]Institut Jules Bordet ( Site 0710) Anderlecht, Bruxelles-Capitale, Region De, Belgium, 1070[55]Cliniques Universitaires Saint-Luc ( Site 0701) Brussels, Bruxelles-Capitale, Region De, Belgium, 1200[56]CHC MontLegia ( Site 0707) Liège, Liege, Belgium, 4000[57]Jessa Ziekenhuis Campus Virga Jesse ( Site 0704) Hasselt, Limburg, Belgium, 3500[58]CHU UCL Namur Site de Godinne ( Site 0706) Yvoir, Namur, Belgium, 5530[59]AZ Maria Middelares Gent ( Site 0700) Gent, Oost-Vlaanderen, Belgium, 9000[60]UZ Leuven ( Site 0702) Leuven, Vlaams-Brabant, Belgium, 3000[61]AZ Groeninge ( Site 0705) Kortrijk, West-Vlaanderen, Belgium, 8500[62]Hospital Araujo Jorge Associacao de Combate ao Cancer de Goias ( Site 0205) Goiania, Goias, Brazil, 74605-070[63]ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 0206) Ijui, Rio Grande Do Sul, Brazil, 98700-000[64]Associacao Hospitalar Moinhos de Vento ( Site 0201) Porto Alegre, Rio Grande Do Sul, Brazil, 90035-001[65]Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0202) Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000[66]CEPON - Centro de Pesquisas Oncologicas ( Site 0208) Florianopolis, Santa Catarina, Brazil, 88034-000[67]Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 0207) Itajai, Santa Catarina, Brazil, 88301-220[68]Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0210) São Paulo, Sao Paulo, Brazil, 04014-002[69]Instituto Nacional de Cancer - INCA HC III ( Site 0200) Rio de Janeiro, Brazil, 20560-120[70]Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0209) Sao Paulo, Brazil, 01246-000[71]Clinica de Pesquisas e Ctro de Estudos Onc. Ginecol. e Mamaria Ltda ( Site 0204) Sao Paulo, Brazil, 01317-001[72]Cross Cancer Institute ( Site 0115) Edmonton, Alberta, Canada, T6G 1Z2[73]BC Cancer-Vancouver Center ( Site 0116) Vancouver, British Columbia, Canada, V5Z 4E6[74]Princess Margaret Cancer Centre ( Site 0112) Toronto, Ontario, Canada, M5G 2M9[75]CISSS de la Monteregie-Centre ( Site 0108) Greenfield Park, Quebec, Canada, J4V 2H1[76]Hopital Maisonneuve-Rosemont CIUSSS de l Est de L Ile de Montreal ( Site 0111) Montreal, Quebec, Canada, H1T 2M4[77]Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0114) Montreal, Quebec, Canada, H2X 3E4[78]Jewish General Hospital ( Site 0103) Montreal, Quebec, Canada, H3T 1E2[79]Centre Hospitalier Regional de Trois-Rivieres ( Site 0106) Trois-Rivières, Quebec, Canada, G8Z 3R9[80]CHU de Quebec Universite Laval - Hopital du Saint-Sacrement ( Site 0101) Quebec, Canada, G1S 4L8[81]Anhui Provincial Hospital ( Site 3224) Heifei, Anhui, China, 230001[82]Ruijin Hosp,Shanghai Jiao Tong University School of Medicine ( Site 3215) Shanghai, Anhui, China, 200025[83]Cancer Hospital Chinese Academy of Medical Sciences ( Site 3208) Beijing, Beijing, China, 100021[84]Fujian Medical University Union Hospital-1 Bingfanglou-Oncology ( Site 3207) Fuzhou Fujian, Fujian, China, 350001[85]Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University ( Site 3213) Guangzhou, Guangdong, China, 510289[86]Fourth Hospital Of Hebei Medical University ( Site 3216) Shijia Zhuang, Hebei, China, 050019河北医科大学第四医院[87]Harbin Medical University Cancer Hospital ( Site 3200) Harbin, Heilongjiang, China, 150081
The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant (post-surgery) endocrine therapy in the treatment of adults who have high-risk early-stage estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer.
The primary study hypotheses are: 1) pembrolizumab is superior to placebo, both in combination with the protocol-specified neoadjuvant anticancer therapy, as assessed by pathological Complete Response (pCR) rate defined by the local pathologist, and 2) pembrolizumab is superior to placebo (both in combination with the protocol-specified neoadjuvant and adjuvant anticancer therapies) as assessed by Event-Free Survival (EFS) as determined by the investigator. The study is considered to have met its primary objective if pembrolizumab is superior to placebo with respect to either pCR (ypT0/Tis ypN0) or EFS.
