Phase II Study of PD-1 Inhibition with Cemiplimab in Locally Advanced Hormone Receptor (HR) Positive HER2 Negative or Triple-Negative Breast Cancer Patients Undergoing Standard Neoadjuvant Chemotherapy

Protocol No
IIT-CHAUDHARY-PD1-CEMIPLIMAB
Principal Investigator
Lubna Chaudhary
Phase
II
Summary
In this study we want to assess the effectiveness of adding the drug Cemiplimab to the standard neoadjuvant chemotherapy regimen in patients with estrogen receptor and/or progesterone receptor positive, HER2 negative, or triple-negative invasive breast cancer. The standard neoadjuvant chemotherapy regimen includes Paclitaxel, Carboplatin, Doxorubicin, and Cyclophosphamide. The FDA has approved Cemiplimab to treat some types of skin cancer, but it is not FDA approved to treat any subtypes of breast cancer. Therefore, Cemiplimab is considered investigational in this study. Cemiplimab works by improving the immune system’s response to fight your cancer. Cemiplimab blocks a protein called Programmed cell death protein 1 (PD1) and its interactions with the proteins programmed death ligand 1 (PD-L1) and programmed death ligand 2 (PD-L2). Researchers believe that blocking the activity of these proteins will make an antitumor immune response and allow the standard neoadjuvant chemotherapy regimen to work better. We do not know all the ways that these study drugs may affect people. This study may or may not help you, but we hope the information from this study will help us develop a better treatment for breast cancer.
Description
This project is being done to assess the effectiveness of adding the drug Cemiplimab to the standard neoadjuvant chemotherapy regimen in patients with estrogen receptor and/or progesterone receptor positive, HER2 negative, or triple-negative invasive breast cancer.
Participating Institutions
Froedtert Hospital
Status
OPEN TO ACCRUAL
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