Ignite Creation Date:
2024-05-06 @ 10:49 AM
Last Modification Date:
2024-10-26 @ 12:36 PM
Study NCT ID:
NCT03366844
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-14
First Post:
2017-11-25
Brief Title:
Breast Cancer Study of Preoperative Pembrolizumab Radiation
Sponsor:
Stephen Shiao
Organization:
Cedars-Sinai Medical Center
Study Overview
Official Title:
Preoperative Combination of Pembrolizumab and Radiation Therapy in Patients With Operable Breast Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
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 study is being done to assess the feasibility of pembrolizumab study drug combined with standard radiation to the tumor tumor boost before patients undergo standard treatment that can consist of one or more of the following breast-conserving surgery radiation to the entire breastchest wall after surgery and chemotherapy
Study participants will receive two doses of the study drug intravenously through the vein before their planned breast surgery or chemotherapy The study drug will be administered three weeks apart At the time of the second dose radiation to the tumor in the affected breast will be given This type of radiation treatment is called a tumor boost which is a standard part of radiation therapy for breast cancer that may occur either before or after planned breast-conserving surgery Patients will receive breast surgery or begin chemotherapy approximately six weeks after your first dose of the study drug
Study participants will receive two doses of the study drug intravenously through the vein before their planned breast surgery or chemotherapy The study drug will be administered three weeks apart At the time of the second dose radiation to the tumor in the affected breast will be given This type of radiation treatment is called a tumor boost which is a standard part of radiation therapy for breast cancer that may occur either before or after planned breast-conserving surgery Patients will receive breast surgery or begin chemotherapy approximately six weeks after your first dose of the study drug
Detailed Description:
With more than 1 million new cases diagnosed yearly worldwide breast cancer is a global public health burden Over the past decade molecular subtyping of breast cancer has identified intrinsic subtypes that may be at enhanced risk for both local and distant recurrence This study focuses on the immunogenicity of high-risk breast cancer subtypes that are likely to display a dense lymphocytic infiltration including including TNBC and HRHER2- tumors
Immune build up via immune co-stimulatory molecules permits the ensuing immune response to strengthen and destroy cancer systemically Thus the effect of the anti-tumor immune response initiated by the radiation to an intact tumor by combination with checkpoint blockade is increased
Pembrolizumab is an optimal immunotherapy agent to study as this agent has recently been FDA approved for use in multiple tumor types It is therefore ready to be tested for efficacy in other disease sites and in combination with other treatments
Immune build up via immune co-stimulatory molecules permits the ensuing immune response to strengthen and destroy cancer systemically Thus the effect of the anti-tumor immune response initiated by the radiation to an intact tumor by combination with checkpoint blockade is increased
Pembrolizumab is an optimal immunotherapy agent to study as this agent has recently been FDA approved for use in multiple tumor types It is therefore ready to be tested for efficacy in other disease sites and in combination with other treatments
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