Ignite Creation Date:
2024-05-06 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 12:01 PM
Study NCT ID:
NCT02752685
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-06
First Post:
2016-04-25
Brief Title:
Phase II Study of Pembrolizumab and Nab-paclitaxel in HER-2 Negative Metastatic Breast Cancer
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
Phase II Study of Pembrolizumab and Nab-paclitaxel in HER-2 Negative Metastatic Breast Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single-arm open-label multi-cohort Phase II study evaluating the safetytolerability and clinical activity of the combination of nab-paclitaxel and the antibody against programmed cell death 1 PD-1 pembrolizumab in patients with human epidermal growth factor receptor HER-2 negative metastatic breast cancer n50 There will be two cohorts of patients consisting of a triple negative breast cancer TNBC cohort with 30 subjects and a hormone receptor HR-positive cohort with 20 subjects There will be an initial safety run-in with 12 subjects from the TNBC and HR-positive cohort 6 patients from each cohort If no unexpected toxicity is observed as defined in the study protocol then enrollment will continue to complete both cohorts 30 total TNBC 20 total in HR positive cohort The subjects from the run in safety part will be included in the Phase II analysis Tumor expression of programmed cell death ligand 1 PD-L1 is not required for enrollment in the study but will be assessed as possible predictive marker
Detailed Description:
None
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?:
None
Is an FDA AA801 Violation?:
None