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Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Sac-TMT (Sacituzumab Tirumotecan, MK-2870) Followed by Carboplatin/Paclitaxel vs Chemotherapy, Both in Combination With Pembrolizumab as Neoadjuvant Therapy for High-Risk, Early-Stage, Triple-Negative Breast Cancer or Hormone Receptor-Low Positive/Human Epidermal Growth Factor Receptor-2 Negative Breast Cancer.

Primary:
To compare sac-TMT followed by carboplatin/paclitaxel versus chemotherapy, both in combination with pembrolizumab as neoadjuvant therapy with respect to rate of pCR (ypT0/Tis ypN0) at the time of surgery, as assessed by local pathologist in all participants. Hypothesis (H1): Sac-TMT followed by carboplatin/paclitaxel is superior to chemotherapy, both in combination with pembrolizumab as neoadjuvant therapy with respect to rate of pCR (ypT0/Tis ypN0), as assessed by local pathologist in all participants.

Protocol Number: 042504
Phase: Phase III
Applicable Disease Sites: Breast
Drugs Involved: CARBOPLATIN
PACLITAXEL
Pembrolizumab (MK-3475)
Sacituzumab Tirumotecan, MK-2870
Principal Investigator: Mridula A George
Scope: National
Therapies Involved: Chemotherapy multiple agents systemic
Participating Institutions:
  • RWJBarnabas Health
    • Clara Maass Medical Center
    • Jersey City Medical Center, Jersey City
    • Monmouth Medical Center
    • Newark Beth Israel Medical Center
    • Robert Wood Johnson University Hospital, Somerset
    • Trinitas Hospital and Comprehensive Cancer Center
  • Rutgers University
Inclusion & Exclusion Criteria

Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

For further information about clinical trials, please contact us at 732-235-7356.