A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Sac-TMT (Sacituzumab Tirumotecan, MK-2870) Followed by Carboplatin/Paclitaxel vs Chemotherapy, Both in Combination With Pembrolizumab as Neoadjuvant Therapy for High-Risk, Early-Stage, Triple-Negative Breast Cancer or Hormone Receptor-low Positive/Human Epidermal Growth Factor Receptor-2 Negative Breast Cancer
A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Sac-TMT (Sacituzumab Tirumotecan, MK-2870) Followed by Carboplatin/Paclitaxel vs Chemotherapy, Both in Combination With Pembrolizumab as Neoadjuvant Therapy for High-Risk, Early-Stage, Triple-Negative Breast Cancer or Hormone Receptor-low Positive/Human Epidermal Growth Factor Receptor-2 Negative Breast Cancer
Researchers are looking for new ways to treat types of breast cancer that are both:
Sacituzumab tirumotecan (also known as sac-TMT or MK-2870), the study medicine, is a type of targeted therapy. A targeted therapy is a treatment that works to control how specific types of cancer cells grow and spread.
The main goals of this study are to learn if people who receive sac-TMT, pembrolizumab, and chemotherapy:
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
Has previously untreated high-risk, early-stage, non-metastatic (M0) breast cancer (BC), defined as any of the following combined primary tumor (T) and regional lymph node (N) staging per AJCC 8th edition criteria as assessed by the physician investigator based on radiological and/or clinical assessment:
The participant must have a centrally confirmed diagnosis of BC that is triple-negative or HR-low+/HER2- (defined as estrogen receptor (ER)-low+ expression in 1% to 10% cells and HER2- as by the most recent American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines.
Provides a core needle biopsy from the primary breast tumor at screening to the central laboratory.
Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed within 28 days before Cycle1 Day 1 (C1D1).
Demonstrates adequate organ function.
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
Trialsites@msd.com1-888-577-8839
Gilbert, Arizona 85234, United States
480-256-6444
Burbank, California 91505, United States
Long Beach, California 90806, United States
Mountain View, California 94040, United States
Newport Beach, California 92663, United States
Denver, Colorado 80218, United States
Grand Junction, Colorado 81501, United States
Altamonte Springs, Florida 32701, United States
St. Petersburg, Florida 33701, United States
Fort Wayne, Indiana 46804, United States
Shreveport, Louisiana 71103, United States
St Louis, Missouri 63110, United States
Hackensack, New Jersey 07601, United States
New Brunswick, New Jersey 08901, United States
Cincinnati, Ohio 45220, United States
Tigard, Oregon 97223, United States
Charleston, South Carolina 29425, United States
Lubbock, Texas 79430, United States
Midlothian, Virginia 23114, United States
Roanoke, Virginia 24014, United States
Mar del Plata, Buenos Aires B7600FZO, Argentina
Buenos Aires, Buenos Aires F.D. C1199ABB, Argentina
Buenos Aires, Buenos Aires F.D. C1431FWO, Argentina
San Salvador de Jujuy, Jujuy Province Y4600EHA, Argentina
San Miguel de Tucumán, Tucumán Province T4000IHE, Argentina
Liège, Liege 4000, Belgium
Natal, Rio Grande do Norte 59062-000, Brazil
Passo Fundo, Rio Grande do Sul 99010-080, Brazil
Porto Alegre, Rio Grande do Sul 90035-074, Brazil
Barretos, São Paulo 14784-400, Brazil
São José do Rio Preto, São Paulo 15090-000, Brazil
Ottawa, Ontario K1H 8L6, Canada
Montreal, Quebec H2X 3E4, Canada
Québec, Quebec G1S 4L8, Canada
Sherbrooke, Quebec J1H 5N4, Canada
Trois-Rivières, Quebec G8Z 3R9, Canada
Santiago, Region M. de Santiago 7500653, Chile
Xiamen, Fujian 361009, China
Guangzhou, Guangdong 511400, China
Nanning, Guangxi 530201, China
Haerbin, Heilongjiang 150081, China
0451-86298104
Xi'an, Shaanxi 710000, China
Shanghai, Shanghai Municipality 200000, China
Ürümqi, Xinjiang 830000, China
Hangzhou, Zhejiang 310017, China
Bogotá, Bogota D.C. 110131, Colombia
Bogotá, Bogota D.C. 111321, Colombia
Brno, Brno-mesto 656 53, Czechia
Nový Jičín, Moravian-Silesian Region 741 01, Czechia
Hradec Králové, 500 05, Czechia
Liberec, 460 01, Czechia
Helsinki, Uusimaa 00029, Finland
Montpellier, Herault 34070, France
Rennes, Ille-et-Vilaine 35000, France
Munich, Bavaria 80336, Germany
Paderborn, North Rhine-Westphalia 33098, Germany
Koblenz, Rhineland-Palatinate 56068, Germany
Saarbrücken, Saarland 66113, Germany
Guatemala City, 01015, Guatemala
Pokfulam, Hong Kong
85239103299
Miskolc, Borsod-Abauj Zemplen county 3526, Hungary
Kecskemét, Bács-Kiskun county 6000, Hungary
Szeged, Csongrád megye 6720, Hungary
Zalaegerszeg, Zala County 8900, Hungary
Budapest, 1122, Hungary
Livorno, Tuscany 57124, Italy
Roma, 00168, Italy
Matsuyama, Ehime 791-0280, Japan
Sapporo, Hokkaido 003-0804, Japan
Kahoku-gun, Ishikawa-ken 920-0293, Japan
+81-76-286-3511
Sunto-gun, Shizuoka 411-8777, Japan
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Shinagawa, Tokyo 142-8666, Japan
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Lembah Pantai, Kuala Lumpur 59100, Malaysia
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Lørenskog, Akershus 1474, Norway
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Concepción, Departamento de Junín 12125, Peru
Trujillo, La Libertad 13001, Peru
Surquillo, Muni Metro de Lima 15038, Peru
Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-796, Poland
Krakow, Lesser Poland Voivodeship 31-115, Poland
Wałbrzych, Lower Silesian Voivodeship 58-309, Poland
Warsaw, Masovian Voivodeship 02-781, Poland
Bialystok, Podlaskie Voivodeship 15-027, Poland
Słupsk, Pomeranian Voivodeship 76-200, Poland
Olsztyn, Warmian-Masurian Voivodeship 10-228, Poland
Koszalin, West Pomeranian Voivodeship 75-581, Poland
Kielce, Świętokrzyskie Voivodeship 25-734, Poland
Lisbon, Lisbon District 1449-005, Portugal
Singapore, Central Singapore 168583, Singapore
Port Elizabeth, Eastern Cape 6045, South Africa
Pretoria, Gauteng 0181, South Africa
Kyonggi-do, Kyonggi-do 13620, South Korea
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Taegu, Taegu-Kwangyokshi 41404, South Korea
Seoul, 06591, South Korea
L'Hospitalet de Llobregat, Barcelona 08908, Spain
Salamanca, Castille and León 37007, Spain
Santiago de Compostela, La Coruna 19706, Spain
Pozuelo de Alarcón, Madrid 28223, Spain
Stockholm, Stockholm County 171 64, Sweden
Pathumwan, Bangkok 10330, Thailand
+6622564533
Muang, Chiang Mai 50200, Thailand
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Sıhhiye, Ankara 06230, Turkey (Türkiye)
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Adana, 01250, Turkey (Türkiye)
Istanbul, 34147, Turkey (Türkiye)
Cherkasy, Cherkasy Oblast 18009, Ukraine
Chernivtsi, Chernivetska Oblast 58013, Ukraine
Ivano-Frankivsk, Ivano-Frankivsk Oblast 76018, Ukraine
Kropyvnytsky, Kirovohrad Oblast 25011, Ukraine
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Dundee, Dundee City DD2 1SG, United Kingdom
Nottingham, Nottinghamshire NG5 1PB, United Kingdom
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