A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032)

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

About this trial

Researchers are looking for new ways to treat types of breast cancer that are both:

* High-risk, which means the cancer may have a higher chance of getting worse or coming back after treatment * Early-stage, which means the cancer is in the breast or the lymph nodes around the breast The 2 types of breast cancer in this study are triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive/human epidermal growth factor receptor-2 (HER2) negative breast cancer. These cancers have zero or a low amount of a protein called HER2 and other proteins that attach to the hormones estrogen or progesterone.

Sacituzumab tirumotecan (also known as sac-TMT or MK-2870), the study medicine, is a type of targeted therapy. A targeted therapy is a treatment that works to control how specific types of cancer cells grow and spread.

The main goals of this study are to learn if people who receive sac-TMT, pembrolizumab, and chemotherapy:

* Have fewer cancer cells found in the tumors and lymph nodes removed during surgery compared to those who receive only pembrolizumab and chemotherapy * Live longer without the cancer growing, spreading, or coming back compared to people who receive only pembrolizumab with chemotherapy

Eligibility criteria

Qualifiers

cT1c, N1-N2

cT2, N0-N2

cT3, N0-N2

cT4a-d, N0-N2

Disqualifiers

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 C1D1.

Trial design

Treatments tested in this trial

  • Sacituzumab tirumotecan
  • Pembrolizumab
  • Rescue Medication
  • Carboplatin
  • Paclitaxel
  • Doxorubicin
  • Epirubicin
  • Cyclophosphamide
  • Capecitabine
  • Olaparib

Treatment groups

2,400 Participants
are divided into 2 treatment groups

Sponsors and collaborators