Cemiplimab in High Risk or Locally Advanced Hormone Receptor Positive HER2 Negative or Triple-Negative Breast Cancer

Invasive Breast Cancer Clinical Trial

Official title: 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

Status Recruiting

Clinical Trial Summary

This is a single-arm, open-label, phase 2 study that will enroll 36 subjects, who have pathologically proven diagnosis of invasive breast cancer, clinical stage tumor 1-3 (cT1-T3), node 0-3 (cN0-N3), metastasis 0 (cM0), hormone receptor positive (HR+) (estrogen-receptor-positive (ER+) and/or progesterone-receptor-positive (PR+) human epidermal growth factor receptor 2 (HER2) negative or hormone receptor-negative (HR-) (estrogen-receptor-negative (ER-) and progesterone-receptor-negative (PR-) human epidermal growth factor receptor 2 (HER2) negative/triple-negative breast cancer.

Clinical Trial Description

Hypothesis: The addition of cemiplimab (PD-1 inhibitor) to standard neoadjuvant chemotherapy in patients with locally advanced HR+ HER2 negative or triple-negative (TN) breast cancer having positive PD-L1 and/or PD-L2 tumor expression will be associated with an increase in pathologic complete response of at least 20%.

Primary Objectives:

Assess pathologic responses in patients treated with neoadjuvant chemotherapy and cemiplimab. ;

Related Conditions & MeSH terms

• Breast Neoplasms
• Invasive Breast Cancer
• Triple Negative Breast Neoplasms

• NCT number: NCT04243616
• Study type: Interventional
• Source: Medical College of Wisconsin
• Contact: Medical College of Wisconsin Cancer Center Clinical Trials Offic
• Phone: 414-805-8900
• Email: cccto@mcw.edu
• Status: Recruiting
• Phase: Phase 2
• Start date: March 5, 2020
• Completion date: January 1, 2026