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Recruiting Phase 3 NCT06966700

A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032)

Phase 3 – large-scale trial before approval
Conditions: Breast Neoplasms Triple Negative Breast Neoplasms HR Low-Positive/HER2-Negative Breast Neoplasms

Sponsor: Merck Sharp & Dohme LLC

trial.available_in: БГ
Overview
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
Who can participate
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 investigator based on radiological and/or clinical assessment: * cT1c, N1-N2 * cT2, N0-N2 * cT3, N0-N2 * cT4a-d, N0-N2 * 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 treatment randomization. * Demonstrates adequate organ function. Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Metastatic (Stage IV) breast cancer or clinical node stage 3 (cN3) nodal involvement * Has received any prior treatment, including radiation, systemic therapy,and/or definitive surgery for currently diagnosed breast cancer * Has undergone excisional biopsy of the primary tumor, axillary lymph node dissection, and/or axillary sentinel lymph node biopsy prior to study treatment. * Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization. * Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, CTLA-4, OX- 40, CD137). * Received prior treatment with a TROP2-targeted antibody-drug conjugate (ADC). * Received prior treatment with a topoisomerase I inhibitor-containing ADC. * Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. * Known additional malignancy that is progressing or has required active treatment within the past 5 years. * Uncontrolled systemic disease. * History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
Locations 36
Argentina (1)
Instituto de Investigaciones Clinicas Mar del Plata ( Site 6008)
Mar del Plata , Buenos Aires
Study Coordinator
Australia (1)
Chris O'Brien Lifehouse ( Site 1206)
Camperdown , New South Wales
Study Coordinator
Belgium (1)
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman ( Site 3204)
Liège , Liege
Study Coordinator
Brazil (1)
PRONUTRIR ( Site 6120)
Fortaleza , Ceará
Study Coordinator
Canada (1)
NL Health Services ( Site 0232)
St. John's , Newfoundland and Labrador
Study Coordinator
Chile (1)
Centro de Estudios Clínicos SAGA ( Site 6205)
Santiago , Region M. de Santiago
Study Coordinator
China (1)
Anhui Provincial Cancer Hospital ( Site 2234)
Hefei , Anhui
Study Coordinator
Colombia (1)
Instituto de Cancerología-Oncology ( Site 6302)
Medellín , Antioquia
Study Coordinator
Czech Republic (1)
Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 3400)
Brno , Brno-mesto
Study Coordinator
Finland (1)
Oulun yliopistollinen sairaala ( Site 3603)
Oulu , North Ostrobothnia
Study Coordinator
France (1)
Institut Paoli Calmettes. ( Site 3906)
Marseille , Bouches-du-Rhone
Study Coordinator
Germany (1)
InVO Institut für Versorgungsforschung in der Onkologie ( Site 4009)
Koblenz , Rhineland-Palatinate
Study Coordinator
Greece (1)
General Hospital of Athens - Laiko ( Site 4104)
Athens , Attica
Study Coordinator
Guatemala (1)
MEDI-K ( Site 6400)
Guatemala City
Study Coordinator
Hong Kong (1)
Hong Kong United Oncology Centre ( Site 1304)
Jordan
Study Coordinator
Hungary (1)
Borsod-Abaúj-Zemplén Vármegyei Központi Kórház És Egyetemi Oktatókórház ( Site 4208)
Miskolc , Borsod-Abauj Zemplen county
Study Coordinator
Israel (1)
Rambam Health Care Campus ( Site 4400)
Haifa
Study Coordinator
Italy (1)
Azienda USL Toscana Nord Ovest_Ospedale Civile di Livorno ( Site 4503)
Livorno , Tuscany
Study Coordinator
Japan (1)
Nagoya City University Hospital ( Site 2310)
Nagoya , Aichi-ken
Study Coordinator
Malaysia (1)
University Malaya Medical Centre. ( Site 1503)
Lembah Pantai , Kuala Lumpur
Study Coordinator
New Zealand (1)
Bowen Icon Cancer Centre ( Site 1001)
Crofton Downs , Wellington Region
Study Coordinator
Norway (1)
Akershus Universitetssykehus ( Site 3701)
Lørenskog , Akershus
Study Coordinator
Peru (1)
Instituto Regional de Enfermedades Neoplasicas del Centro (IREN CENTRO) ( Site 6605)
Concepción , Departamento de Junín
Study Coordinator
Philippines (1)
THE MEDICAL CITY ( Site 1602)
Pasig , National Capital Region
Study Coordinator
Poland (1)
Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 4616)
Bydgoszcz , Kuyavian-Pomeranian Voivodeship
Study Coordinator
Romania (1)
Spitalul Clinic Filantropia ( Site 4801)
Bucharest
Study Coordinator
Singapore (1)
National Cancer Centre Singapore ( Site 1700)
Singapore , Central Singapore
Study Coordinator
South Africa (1)
CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 4907)
Port Elizabeth , Eastern Cape
Study Coordinator
South Korea (1)
National Cancer Center ( Site 1800)
Goyang-si , Kyonggi-do
Study Coordinator
Spain (1)
Institut Català d'Oncologia - L'Hospitalet ( Site 5001)
L'Hospitalet de Llobregat , Barcelona
Study Coordinator
Sweden (1)
Skånes Universitetssjukhus Malmö ( Site 3802)
Malmo , Skåne County
Study Coordinator
Taiwan (1)
Taichung Veterans General Hospital ( Site 1904)
Taichung
Study Coordinator
Thailand (1)
Faculty of Medicine Siriraj Hospital ( Site 2000)
Bangkok , Bangkok
Study Coordinator
Ukraine (1)
COMMUNAL NONPROFIT ENTERPRISE CLINICAL CENTER OF ONCOLOGY, HEMATOLOGY, TRANSPLANTOLOGY AND PALLIATI ( Site 5207)
Cherkasy , Cherkasy Oblast
Study Coordinator
United Kingdom (1)
Ninewells Hospital and Medical School ( Site 5300)
Dundee , Dundee City
Study Coordinator
United States (1)
Banner MD Anderson Cancer Center ( Site 0066)
Gilbert , Arizona
Study Coordinator
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
30.06.2025
Completion date
29.12.2034
Registry ID
NCT06966700
Source
anzctr
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