Ignite Creation Date:
2024-05-06 @ 2:13 PM
Last Modification Date:
2024-10-26 @ 1:26 PM
Study NCT ID:
NCT04243616
Status:
RECRUITING
Last Update Posted:
2024-02-06
First Post:
2020-01-24
Brief Title:
Cemiplimab in High Risk or Locally Advanced Hormone Receptor Positive HER2 Negative or Triple-Negative Breast Cancer
Sponsor:
Medical College of Wisconsin
Organization:
Medical College of Wisconsin
Study Overview
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
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 andor 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 negativetriple-negative breast cancer
Detailed 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 andor 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
Primary Objectives
Assess pathologic responses in patients treated with neoadjuvant chemotherapy and cemiplimab
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None