Find what you need in the Fundación Valle del Lili

Are you looking for a medical service, a specialty, a healthcare professional, or information about appointments and programs?
Use our smart search engine to easily access everything that the Fundación Valle del Lili.

Preparation for exams and procedures Hospital Padrino Library FVL daily Search for specialty Book your Appointment Specialists

Services for you

Schedule a medical appointment
Schedule a medical check-up
Find a specialist
Check results
Preparing for medical exams
Industries
Make payments

Clinical study of sacituzumab tirumotecan (Sac-TMT, MK-2870) in people with breast cancer (MK-2870-032)-06966700

Study ID: 06966700

A phase 3, randomized, open-label study to evaluate the efficacy and safety of Sac-TMT (sacituzumab tirumotecan, MK-2870) followed by carboplatin/paclitaxel versus chemotherapy, both in combination with pembrolizumab as neoadjuvant therapy for early-stage high-risk triple-negative breast cancer or hormone receptor low/human epidermal growth factor receptor 2 negative breast cancer.

About the study:

 

Inclusion criteria: The main inclusion criteria include, but are not limited to, the following: * Has early-stage, high-risk, previously untreated non-metastatic (M0) breast cancer (BC), defined as any of the following combined primary tumor (T) and regional lymph node (N) staging according to the 8th edition AJCC criteria, as assessed by the investigator based on radiologic or clinical evaluation: * cT1c, N1-N2 * cT2, N0-N2 * cT3, N0-N2 * cT4a-d, N0-N2 * Participant must have a centrally confirmed diagnosis of BC that is triple-negative or HR-low+/HER2- (defined as estrogen receptor (ER) expression-low+ in 1% to 10% of cells and HER2-), according to the most recent American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines. * Provides a core needle biopsy of the primary breast tumor at screening to the central laboratory. * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed within 28 days prior to treatment randomization. * Demonstrates adequate organ function. Exclusion Criteria: The primary exclusion criteria include, but are not limited to, the following: * Metastatic breast cancer (stage IV) or clinical stage 3 (cN3) lymph node involvement * Has received any prior treatment, including radiation therapy, 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 cancer therapy, including investigational agents, within 4 weeks prior to randomization. * Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent targeting another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137). * Received prior treatment with an antibody-drug conjugate (ADC) targeting TROP2. * Received prior treatment with an ADC containing a topoisomerase I inhibitor. * Received a live or attenuated vaccine within 30 days prior to the first dose of the study intervention. * Known additional malignancy that is progressing or has required active treatment within the past 5 years. * Uncontrolled systemic disease. * History of pneumonitis/interstitial lung disease (noninfectious) requiring steroids or current pneumonitis/interstitial lung disease.

Total length

Target audiences

Ages: 18 years - N/A years
Sex: All

Location

Merck Sharp & Dohme LLC

Request an appointment via WhatsApp
Request a call
Medical Directory
Check results
Contact