Last updated 35 days ago
A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032)
2400 patients around the world
Available in United States, Argentina
Merck Sharp & Dohme LLC
7Research sites
2400Patients around the world
This study is for people with
Breast Cancer
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
- 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.
Sites
CEMIC - Hospital Universitario Sede Saavedra - CABA, Buenos Aires
Recruiting
Instituto de Investigaciones Clínicas Mar del Plata
Recruiting
Fundación Ars Médica - San Salvador de Jujuy
Recruiting
Sanatorio Finochietto
Recruiting
Sanatorio de la Cañada - Córdoba
Recruiting
Sanatorio Allende (Nueva Córdoba)
Recruiting
Sanatorio Parque - Rosario
Recruiting
StudyMK-2870-032
SponsorMerck Sharp & Dohme LLC
Study typeInterventional
Conditions
Breast Cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06966700
