A Study of Sacituzumab Tirumotecan (MK-2870) as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010)
Launched by MERCK SHARP & DOHME LLC · Mar 7, 2024
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment option for patients with a specific type of breast cancer called hormone receptor positive and HER2 negative (HR+/HER2-). The researchers want to see how well a drug called sacituzumab tirumotecan works on its own and in combination with another drug called pembrolizumab. They are comparing these treatments to the standard care that doctors usually choose for patients. The main goal is to find out if these new treatments help patients live longer without their cancer getting worse.
To participate in this study, patients should have advanced breast cancer that cannot be surgically removed and have already tried hormone therapy without success. They also need to be candidates for chemotherapy and generally be in good health. If you or a loved one are dealing with this type of breast cancer and meet these criteria, joining this trial could provide access to new treatments that might be more effective. Participants will be closely monitored throughout the study and will receive the necessary care and support during their treatment journey.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Has unresectable locally advanced or metastatic centrally-confirmed hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer
- • Has radiographic disease progression on one or more lines of endocrine therapy for unresectable locally advanced/metastatic HR+/HER2- breast cancer, with one in combination with a CDK4/6 inhibitor
- • Is a chemotherapy candidate
- • Has an eastern cooperative oncology group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization
- • Has adequate organ function
- • Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy
- • Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable HBV viral load
- • Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
- Exclusion Criteria:
- • Has breast cancer amenable to treatment with curative intent
- • Has experienced an early recurrence (\<6 months after completing adjuvant/neoadjuvant chemotherapy) and therefore is eligible to receive second-line (2L) treatment
- • Has symptomatic advanced/metastatic visceral spread at risk of rapidly evolving into life-threatening complications
- • Has received prior chemotherapy for unresectable locally advanced or metastatic breast cancer
- • Active autoimmune disease that has required systemic treatment in the past 2 years
- • History of (noninfectious) pneumonitis/interstitial lung disease that requires steroids, or has current pneumonitis/interstitial lung disease
- • Has an active infection requiring systemic therapy
About Merck Sharp & Dohme Llc
Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., is a leading global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines and vaccines that address unmet medical needs. With a strong focus on research and development, Merck Sharp & Dohme leverages advanced science and technology to enhance patient outcomes across various therapeutic areas, including oncology, infectious diseases, and cardiovascular health. Committed to ethical practices and regulatory compliance, the company actively engages in clinical trials to advance medical knowledge and improve health care for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Warszawa, Mazowieckie, Poland
Kielce, Swietokrzyskie, Poland
Haifa, , Israel
Rimouski, Quebec, Canada
Nyack, New York, United States
Petah Tikva, , Israel
Tainan, , Taiwan
Hksar, , Hong Kong
Jerusalem, , Israel
Ramat Gan, , Israel
Seoul, , Korea, Republic Of
Zürich, Zurich, Switzerland
Baltimore, Maryland, United States
San José, San Jose, Costa Rica
Shatin, , Hong Kong
San José, San Jose, Costa Rica
Seoul, , Korea, Republic Of
Taipei, , Taiwan
Stony Brook, New York, United States
Rosario, Santa Fe, Argentina
Buenos Aires, , Argentina
Cordoba, , Argentina
La Rioja, , Argentina
Frankston, Victoria, Australia
Santiago, Region M. De Santiago, Chile
Santiago, Region M. De Santiago, Chile
Santiago, Region M. De Santiago, Chile
Santiago, Region M. De Santiago, Chile
Santiago, Region M. De Santiago, Chile
Santa Ana, San Jose, Costa Rica
San Jose, , Costa Rica
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Kuala Lumpur, , Malaysia
Hato Rey, , Puerto Rico
San Juan, , Puerto Rico
Basel, Basel Stadt, Switzerland
Thun, Berne, Switzerland
Changhua County, Changhua, Taiwan
Taipei, , Taiwan
London, London, City Of, United Kingdom
Tyler, Texas, United States
Altamonte Springs, Florida, United States
Thomasville, Georgia, United States
Ciudad Autónoma De Buenos Aires, Caba, Argentina
Medellín, Antioquia, Colombia
Valledupar, Cesar, Colombia
Monteria, Cordoba, Colombia
Bogota, Distrito Capital De Bogota, Colombia
Cali, Valle Del Cauca, Colombia
Kaohsiung, , Taiwan
Truro, England, United Kingdom
Buenos Aires, , Argentina
Macquarie University, New South Wales, Australia
Westmead, New South Wales, Australia
Taoyuan, , Taiwan
São Paulo, Sao Paulo, Brazil
Santiago, Region M. De Santiago, Chile
Eindhoven, Noord Brabant, Netherlands
Amersfoort, Utrecht, Netherlands
Porto Alegre, Rio Grande Do Sul, Brazil
Santa Cruz Do Sul, Rio Grande Do Sul, Brazil
Montpellier, Languedoc Roussillon, France
Portland, Oregon, United States
Murdoch, Western Australia, Australia
Teresina, Piaui, Brazil
Larissa, Thessalia, Greece
Kaposvár, Somogy, Hungary
Budapest, , Hungary
Johor Bahru, Johor, Malaysia
Kuching, Sarawak, Malaysia
Amsterdam, Noord Holland, Netherlands
Auckland, , New Zealand
Bydgoszcz, Kujawsko Pomorskie, Poland
Siedlce, Mazowieckie, Poland
Wieliszew, Mazowieckie, Poland
Rzeszow, Podkarpackie, Poland
Gdynia, Pomorskie, Poland
Gliwice, Slaskie, Poland
Koszalin, Zachodniopomorskie, Poland
București, Bucuresti, Romania
Florești, Cluj, Romania
Bucuresti, , Romania
Cluj, , Romania
Singapore, Central Singapore, Singapore
Valencia, Valenciana, Comunitat, Spain
Madrid, , Spain
Baton Rouge, Louisiana, United States
Portland, Oregon, United States
Porto Alegre, Rio Grande Do Sul, Brazil
Taubaté, Sao Paulo, Brazil
Sao Paulo, , Brazil
Paris, Orne, France
Athens, Attiki, Greece
Thessaloniki, Kentriki Makedonia, Greece
Szeged, Csongrad, Hungary
Debrecen, , Hungary
Milano, Lombardia, Italy
Ciudad De México, Distrito Federal, Mexico
Mexico City, Distrito Federal, Mexico
Guadalajara, Jalisco, Mexico
Arnhem, Gelderland, Netherlands
Breda, Noord Brabant, Netherlands
Pozuelo De Alarcon, Madrid, Spain
Barcelona, , Spain
Sevilla, , Spain
Fullerton, California, United States
Orlando, Florida, United States
Montreal, Quebec, Canada
Antofagasta, , Chile
Nantes, Loire Atlantique, France
Lyon, Rhone Alpes, France
Paris, , France
Zalaegerszeg, Zala, Hungary
Petah Tikva, , Israel
Aviano, Friuli Venezia Giulia, Italy
Rozzano, Milano, Italy
Bologna, , Italy
Roma, , Italy
Arequipa, Ariqipa, Peru
Jesús María, Lima, Peru
Lima, Muni Metro De Lima, Peru
Lima, , Peru
Bialystok, Podlaskie, Poland
Lisbon, Lisboa, Portugal
Cordoba, , Spain
Madrid, , Spain
Changhua County, Changhua, Taiwan
Kaohsiung, , Taiwan
Tainan, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Taoyuan, , Taiwan
Nottingham, , United Kingdom
Toronto, Ontario, Canada
New Haven, Connecticut, United States
Gent, Oost Vlaanderen, Belgium
Montreal, Quebec, Canada
Caen, Calvados, France
San Pedro Garza Garcia, Nuevo Leon, Mexico
Maastricht, Limburg, Netherlands
London, London, City Of, United Kingdom
Namur, , Belgium
Marousi, Attiki, Greece
Blackpool, , United Kingdom
Chandler, Arizona, United States
Anderlecht, Bruxelles Capitale, Region De, Belgium
Brussels, Bruxelles Capitale, Region De, Belgium
Dublin, , Ireland
Genova, , Italy
Milano, , Italy
Stockholm, Stockholms Lan, Sweden
Ankara, , Turkey
Santiago, Region M. De Santiago, Chile
Vejle, Syddanmark, Denmark
Zwolle, Overijssel, Netherlands
Lisbon, Lisboa, Portugal
Singapore, North East, Singapore
Adana, , Turkey
Boston, Massachusetts, United States
Madison, Wisconsin, United States
Ciudad Autónoma De Buenos Aires, Caba, Argentina
Santiago, Region M. De Santiago, Chile
Copenhagen, Hovedstaden, Denmark
Odense C, Syddanmark, Denmark
Cork, , Ireland
Meldola, Forli Cesena, Italy
Milan, Lombardia, Italy
Uppsala, Uppsala Lan, Sweden
La Jolla, California, United States
Los Alamitos, California, United States
Chicago, Illinois, United States
Philadelphia, Pennsylvania, United States
Midlothian, Virginia, United States
Newmarket, Ontario, Canada
Quebec, , Canada
Santiago., Region M. De Santiago, Chile
Santiago., Region M. De Santiago, Chile
Santiago, Region M. De Santiago, Chile
Naestved, Sjaelland, Denmark
Athens, Attiki, Greece
New Delhi, Delhi, India
Mumbai, Maharashtra, India
Nagoya, Aichi, Japan
Sapporo, Hokkaido, Japan
Isehara, Kanagawa, Japan
Kawasaki, Kanagawa, Japan
Sagamihara, Kanagawa, Japan
Yokohama, Kanagawa, Japan
Tsu, Mie, Japan
Sendai, Miyagi, Japan
Suita, Osaka, Japan
Bunkyo, Tokyo, Japan
Shinagawa, Tokyo, Japan
Shinjuku, Tokyo, Japan
Fukushima, , Japan
Gifu, , Japan
Hiroshima, , Japan
Kagoshima, , Japan
Kumamoto, , Japan
Kyoto, , Japan
Okayama, , Japan
Porto, , Portugal
Borås, Vastra Gotalands Lan, Sweden
Ankara, , Turkey
Samsun, , Turkey
Londonderry, Derry And Strabane, United Kingdom
Hasselt, Limburg, Belgium
Hillerod, Hovedstaden, Denmark
Stanbul, Istanbul, Turkey
Ankara, , Turkey
Stamford, Connecticut, United States
Gainesville, Florida, United States
Baltimore, Maryland, United States
Fort Worth, Texas, United States
Fairfax, Virginia, United States
Richmond, Virginia, United States
Westmead, New South Wales, Australia
Ceske Budejovice, Jihocesky Kraj, Czechia
Osaka, , Japan
Auckland, , New Zealand
Arequipa, Ariqipa, Peru
Pretoria, Gauteng, South Africa
Thessaloniki, , Greece
Shinjuku, Tokyo, Japan
Istanbul, , Turkey
Saint Louis, Missouri, United States
Praha 5, , Czechia
Mumbai, Maharashtra, India
Suita, Osaka, Japan
Koto, Tokyo, Japan
Shinagawa, Tokyo, Japan
Shinjuku, Tokyo, Japan
Monterrey, Nuevo Leon, Mexico
Lisboa, , Portugal
Port Elizabeth, Eastern Cape, South Africa
Sandton, Gauteng, South Africa
Rondebosch, Western Cape, South Africa
Sao Paulo, , Brazil
Monteria., Cordoba, Colombia
Dublin, , Ireland
Hidaka, Saitama, Japan
Edgewood, Kentucky, United States
Poitiers, Vienne, France
Szczecin, Zachodniopomorskie, Poland
Stockholm, Stockholms Lan, Sweden
Uppsala, Uppsala Lan, Sweden
Tyler, Texas, United States
Surrey, British Columbia, Canada
Rimouski, Quebec, Canada
Bogota, Distrito Capital De Bogota, Colombia
New Delhi, Delhi, India
Roma, , Italy
Warszawa, Mazowieckie, Poland
Gliwice, Slaskie, Poland
Kielce, Swietokrzyskie, Poland
Olomouc, Olomoucky Kraj, Czechia
Changhua, , Taiwan
Praha, Praha 5, Czechia
Gilbert, Arizona, United States
Aurora, Colorado, United States
Silver Spring, Maryland, United States
Dallas, Texas, United States
Anderlecht, , Belgium
Brussels, , Belgium
Praha, , Czechia
Valencia, , Spain
London, , United Kingdom
London, , United Kingdom
Patients applied
Trial Officials
Medical Director
Study Director
Merck Sharp & Dohme LLC
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported