A Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Triple-Negative Breast Cancer (MK-2870-011/TroFuse-011)

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMerck Sharp & Dohme LLC

About this trial

Researchers want to know if sacituzumab tirumotecan given alone or with pembrolizumab can treat triple negative breast cancer (TNBC). The main goal of this study is to learn if people treated with sacituzumab tirumotecan alone or with pembrolizumab live longer overall or without the cancer growing or spreading compared to people treated with chemotherapy.

Eligibility criteria

Qualifiers

Has locally recurrent unresectable or metastatic TNBC that cannot be treated with curative intent

Has not received systemic treatment for locally recurrent unresectable or metastatic breast cancer

Participants previously treated for early-stage breast cancer must have completed all prior therapy for early-stage breast cancer with curative intent at least 6 months before the first disease recurrence

Is a candidate for treatment with pembrolizumab and one of the TPC options: paclitaxel or nab-paclitaxel or gemcitabine + carboplatin

Disqualifiers

Has breast cancer amenable to treatment with curative intent

Has TNBC with evaluable tumor programmed death ligand 1 (PD-L1) expression at combined positive score (CPS) ≥10

Has received prior systemic therapy for treatment of locally recurrent unresectable or metastatic breast cancer

Has Grade ≥2 peripheral neuropathy

Trial design

Treatments tested in this trial

  • Sacituzumab tirumotecan
  • Pembrolizumab
  • Rescue Medication
  • Paclitaxel
  • Nab-paclitaxel
  • Gemcitabine
  • Carboplatin

Treatment groups

1,000 Participants
are divided into 3 treatment groups

Sponsors and collaborators