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A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032)
Sponsor: Merck Sharp & Dohme LLC
Summary
Researchers are looking for new ways to treat types of breast cancer that are both: * High-risk, which means the cancer may have a higher chance of getting worse or coming back after treatment * Early-stage, which means the cancer is in the breast or the lymph nodes around the breast The 2 types of breast cancer in this study are triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive/human epidermal growth factor receptor-2 (HER2) negative breast cancer. These cancers have zero or a low amount of a protein called HER2 and other proteins that attach to the hormones estrogen or progesterone. 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: * Have fewer cancer cells found in the tumors and lymph nodes removed during surgery compared to those who receive only pembrolizumab and chemotherapy * Live longer without the cancer growing, spreading, or coming back compared to people who receive only pembrolizumab with chemotherapy
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
2400
Start Date
2025-06-30
Completion Date
2034-12-29
Last Updated
2026-10-13
Healthy Volunteers
No
Conditions
Interventions
Sacituzumab tirumotecan
IV infusion
Pembrolizumab
IV infusion
Rescue Medication
Participants receive rescue medication at the investigators discretion, per approved product label. Recommended rescue medications are histamine -1 (H1) receptor agonist, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent infusion, or steroid mouthwash (dexamethasone or equivalent).
Carboplatin
IV infusion
Paclitaxel
IV infusion
Doxorubicin
IV infusion
Epirubicin
IV infusion
Cyclophosphamide
IV infusion
Capecitabine
Oral tablet
Olaparib
Oral tablet
Locations (331)
Banner MD Anderson Cancer Center ( Site 0066)
Gilbert, Arizona, United States
Mayo Clinic Cancer Center ( Site 0034)
Phoenix, Arizona, United States
University of Arizona Cancer Center ( Site 0035)
Tucson, Arizona, United States
Roy and Patricia Disney Family Cancer Center ( Site 0055)
Burbank, California, United States
Community Cancer Institute ( Site 0100)
Clovis, California, United States
Providence Medical Foundation ( Site 0080)
Fullerton, California, United States
MemorialCare Health System - Long Beach Medical Center ( Site 9556)
Long Beach, California, United States
El Camino Hospital Cancer Center ( Site 0096)
Mountain View, California, United States
Hoag Memorial Hospital Presbyterian ( Site 0010)
Newport Beach, California, United States
Helios Clinical Research ( Site 0061)
Whittier, California, United States
Intermountain Health Cancer Center Saint Joseph ( Site 0062)
Denver, Colorado, United States
Rocky Mountain Cancer Centers (RMCC) ( Site 8006)
Denver, Colorado, United States
Intermountain Health St. Mary's Regional Hospital ( Site 0054)
Grand Junction, Colorado, United States
AdventHealth Medical Group Oncology and Hematology at Altamonte ( Site 0044)
Altamonte Springs, Florida, United States
Florida Cancer Specialists - South ( Site 7004)
Fort Myers, Florida, United States
Bioresearch Partner ( Site 0072)
Hialeah, Florida, United States
Mayo Clinic Hospital ( Site 0013)
Jacksonville, Florida, United States
Florida Cancer Specialists - North ( Site 7002)
St. Petersburg, Florida, United States
City of Hope Cancer Center - Atlanta ( Site 0102)
Newnan, Georgia, United States
Southern Illinois Hospital Services ( Site 9554)
Carterville, Illinois, United States
Fort Wayne Medical Oncology and Hematology ( Site 0084)
Fort Wayne, Indiana, United States
Franciscan Health ( Site 0077)
Indianapolis, Indiana, United States
Ochsner Clinic Foundation ( Site 0021)
New Orleans, Louisiana, United States
Louisiana State University Health Sciences Shreveport ( Site 0053)
Shreveport, Louisiana, United States
New England Cancer Specialists ( Site 0051)
Westbrook, Maine, United States
Mercy Medical Center - Baltimore ( Site 0015)
Baltimore, Maryland, United States
Massachusetts General Hospital Cancer Center ( Site 0091)
Boston, Massachusetts, United States
Dana Farber Cancer Institute ( Site 0090)
Boston, Massachusetts, United States
Saint Luke's Cancer Institute ( Site 0059)
Kansas City, Missouri, United States
Washington University Siteman Cancer Center ( Site 0031)
St Louis, Missouri, United States
Cancer Partners of Nebraska ( Site 0068)
Lincoln, Nebraska, United States
Optum Care Cancer Center ( Site 0050)
Las Vegas, Nevada, United States
Renown Regional Medical Center ( Site 0041)
Reno, Nevada, United States
Hackensack Univ Medical Center (HUMC) ( Site 0007)
Hackensack, New Jersey, United States
Rutgers Cancer Institute of New Jersey ( Site 0076)
New Brunswick, New Jersey, United States
Altru Health System ( Site 0057)
Grand Forks, North Dakota, United States
Good Samaritan Hospital-TriHealth Cancer institute ( Site 0027)
Cincinnati, Ohio, United States
Northwest Cancer Specialists (Compass Oncology) ( Site 8010)
Tigard, Oregon, United States
Medical University of South Carolina-Hollings Cancer Center ( Site 0016)
Charleston, South Carolina, United States
St Francis Cancer Center ( Site 0093)
Greenville, South Carolina, United States
Avera McKennan Hospital ( Site 0002)
Sioux Falls, South Dakota, United States
Avera Cancer Institute - Yankton ( Site 0089)
Yankton, South Dakota, United States
Tennessee Cancer Specialists ( Site 7001)
Knoxville, Tennessee, United States
SCRI Oncology Partners ( Site 7005)
Nashville, Tennessee, United States
Nashville General Hospital ( Site 0017)
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center ( Site 0038)
Nashville, Tennessee, United States
Hendrick Medical Center ( Site 0009)
Abilene, Texas, United States
Texas Oncology - DFW ( Site 8009)
Dallas, Texas, United States
UT Southwestern ( Site 0092)
Dallas, Texas, United States
Texas Oncology - Northeast Texas ( Site 8002)
Flower Mound, Texas, United States
JPS Oncology and Infusion Center ( Site 0083)
Fort Worth, Texas, United States
Kelsey-Seybold Clinic ( Site 0042)
Houston, Texas, United States
Kelsey-Seybold Clinic ( Site 0088)
Houston, Texas, United States
Oncology Consultants P.A. ( Site 0073)
Houston, Texas, United States
Texas Tech University Health Sciences Center ( Site 0087)
Lubbock, Texas, United States
Texas Oncology - San Antonio ( Site 8004)
San Antonio, Texas, United States
Intermountain Medical Center ( Site 0074)
Murray, Utah, United States
Bon Secours Cancer Institute at St. Francis ( Site 0048)
Midlothian, Virginia, United States
Virginia Oncology Associates (VOA) ( Site 8008)
Norfolk, Virginia, United States
Oncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 8005)
Roanoke, Virginia, United States
Fred Hutchinson Cancer Center ( Site 0069)
Seattle, Washington, United States
Cancer Care Northwest ( Site 0003)
Spokane, Washington, United States
Northwest Medical Specialties, PLLC ( Site 0067)
Tacoma, Washington, United States
University of Wisconsin-Madison ( Site 0024)
Madison, Wisconsin, United States
Instituto de Investigaciones Clinicas Mar del Plata ( Site 6008)
Mar del Plata, Buenos Aires, Argentina
Hospital Italiano de Buenos Aires-ginecology ( Site 6003)
Buenos Aires, Buenos Aires F.D., Argentina
Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC) ( Site 6005)
Buenos Aires, Buenos Aires F.D., Argentina
Fundacion Ars Medica ( Site 6004)
San Salvador de Jujuy, Jujuy Province, Argentina
Sanatorio Parque ( Site 6002)
Rosario, Santa Fe Province, Argentina
Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L ( Site 6006)
San Miguel de Tucumán, Tucumán Province, Argentina
Sanatorio Finochietto ( Site 6007)
Buenos Aires, Argentina
Sanatorio Allende - Nueva Córdoba ( Site 6000)
Córdoba, Argentina
Sanatorio de la Cañada - Córdoba ( Site 6001)
Córdoba, Argentina
Chris O'Brien Lifehouse ( Site 1206)
Camperdown, New South Wales, Australia
Macquarie University ( Site 1203)
North Ryde, New South Wales, Australia
Westmead Hospital ( Site 1200)
Westmead, New South Wales, Australia
Monash Health ( Site 1201)
Clayton, Victoria, Australia
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman ( Site 3204)
Liège, Liege, Belgium
Jessa Ziekenhuis ( Site 3200)
Hasselt, Limburg, Belgium
AZORG Campus Aalst-Moorselbaan ( Site 3201)
Aalst, Oost-Vlaanderen, Belgium
UZ Gent ( Site 3202)
Ghent, Oost-Vlaanderen, Belgium
CHU UCL Namur/Site Sainte Elisabeth ( Site 3203)
Namur, Belgium
PRONUTRIR ( Site 6120)
Fortaleza, Ceará, Brazil
Hospital Araújo Jorge ( Site 6100)
Goiânia, Goiás, Brazil
Liga Norte Riograndense Contra o Câncer ( Site 6111)
Natal, Rio Grande do Norte, Brazil
Associação Hospitalar Beneficente São Vicente de Paulo ( Site 6115)
Passo Fundo, Rio Grande do Sul, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 6102)
Porto Alegre, Rio Grande do Sul, Brazil
Hospital São Lucas da PUCRS ( Site 6103)
Porto Alegre, Rio Grande do Sul, Brazil
Clínica de Oncologia Reichow ( Site 6112)
Blumenau, Santa Catarina, Brazil
Fundação Pio XII - Hospital de Câncer de Barretos ( Site 6108)
Barretos, São Paulo, Brazil
Hospital de Base de São José do Rio Preto ( Site 6101)
São José do Rio Preto, São Paulo, Brazil
INCA Hospital do Câncer III ( Site 6107)
Rio de Janeiro, Brazil
BC Cancer - Surrey ( Site 0217)
Surrey, British Columbia, Canada
BC Cancer Vancouver ( Site 0218)
Vancouver, British Columbia, Canada
NL Health Services ( Site 0232)
St. John's, Newfoundland and Labrador, Canada
Royal Victoria Regional Health Centre ( Site 0233)
Barrie, Ontario, Canada
Health Sciences North ( Site 0234)
Greater Sudbury, Ontario, Canada
Lakeridge Health ( Site 0225)
Oshawa, Ontario, Canada
The Ottawa Hospital - General Campus-The Ottawa Hospital Cancer Centre ( Site 0209)
Ottawa, Ontario, Canada
Sault Area Hospital ( Site 0226)
Sault Ste. Marie, Ontario, Canada