Back to Search

A 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

  • Protocol Number: 202507132
  • Principal Investigator: Ademuyiwa, Foluso
  • Cancer Types: Breast

Learn more about this study at: clinicaltrials.gov

For more information on this trial, contact us here:

Phone
800-600-3606
Email
[email protected]

Brief Summary

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

Protocol Interventions

Biological: Pembrolizumab, Drug: Rescue Medication, Drug: Carboplatin, Drug: Paclitaxel, Drug: Doxorubicin, Drug: Epirubicin, Drug: Cyclophosphamide, Drug: Capecitabine, Drug: Olaparib