Study on Sacituzumab Tirumotecan (Sac-TMT, MK-2870) for Treating Breast Cancer

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40

ClinicalTrials ID:NCT06966700

This clinical trial is exploring a new treatment option for people with certain types of early-stage, high-risk breast cancer. The study aims to see if adding the drug Sacituzumab Tirumotecan to standard treatments can help reduce cancer cells and improve patient outcomes.

Patient Parameters

Program Overview

Researchers are testing a new treatment called Sacituzumab Tirumotecan (Sac-TMT, MK-2870) for people with specific types of breast cancer that are early-stage and high-risk. These include triple-negative breast cancer (TNBC) and hormone receptor-low positive/human epidermal growth factor receptor-2 (HER2) negative breast cancer. The study will compare the effects of Sac-TMT combined with pembrolizumab and chemotherapy against pembrolizumab and chemotherapy alone. The main goals are to see if the new combination reduces cancer cells in tumors and lymph nodes and helps patients live longer without the cancer growing or returning.

Eligibility Criteria

Inclusion Criteria

  • Have early-stage, high-risk breast cancer that has not spread to other parts of the body.
  • The cancer must be either triple-negative or hormone receptor-low positive/HER2 negative.
  • Must provide a biopsy sample from the breast tumor for testing.
  • Be in good overall health with an ECOG performance status of 0 or 1.
  • Have adequate organ function as determined by medical tests.

Exclusion Criteria

  • Have breast cancer that has spread to other parts of the body (Stage IV) or involves certain lymph nodes.
  • Have received any previous treatment for the current breast cancer diagnosis, including surgery or radiation.
  • Have had certain types of biopsies or lymph node surgeries before starting the study treatment.
  • Have received any cancer treatment or investigational drugs within four weeks before joining the study.
  • Have previously been treated with specific immune therapies or drugs targeting TROP2 or topoisomerase I.
  • Have received a live vaccine within 30 days before starting the study treatment.
  • Have another active cancer that has required treatment in the past five years.
  • Have uncontrolled systemic diseases or a history of lung conditions requiring steroids.

Locations

FACILITYZIPCITYSTATE
Banner MD Anderson Cancer Center ( Site 0066)85234GilbertArizona
Roy and Patricia Disney Family Cancer Center ( Site 0055)91505BurbankCalifornia
Providence Medical Foundation ( Site 0080)92835FullertonCalifornia
Helios Clinical Research ( Site 0061)90602WhittierCalifornia
Saint Joseph Hospital ( Site 0062)80218DenverColorado
Intermountain Health St. Mary's Regional Hospital ( Site 0054)81501Grand JunctionColorado
Bioresearch Partner ( Site 0072)33013HialeahFlorida
Fort Wayne Medical Oncology and Hematology ( Site 0084)46804Fort WayneIndiana
Franciscan Health ( Site 0077)46237IndianapolisIndiana
Ochsner Clinic Foundation ( Site 0021)70121New OrleansLouisiana

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