Ignite Creation Date:
2024-05-06 @ 9:44 AM
Last Modification Date:
2024-10-26 @ 12:18 PM
Study NCT ID:
NCT03051672
Status:
TERMINATED
Last Update Posted:
2021-04-27
First Post:
2017-02-08
Brief Title:
Phase II PEMBROLIZUMAB PALLIATIVE RADIOTHERAPY IN BC
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Phase II Study Of Pembrolizumab In Combination With Palliative Radiotherapy For Metastatic Hormone Receptor Positive Breast Cancer
Status:
TERMINATED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Based on two-stage design the study ended at stage 1 with no evidence of promise based on pre-specified decision rule
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This research study is studying radiation therapy in combination with an immunotherapy as a possible treatment for metastatic hormone receptor HR positive HER2-negative breast cancer
The interventions involved in this study are
Palliative Radiotherapy
Pembrolizumab
The interventions involved in this study are
Palliative Radiotherapy
Pembrolizumab
Detailed Description:
This research study is a Phase II clinical trial Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease Investigational means that the intervention is being studied
In this research study the investigators are evaluating the safety and effectiveness of palliative radiotherapy radiation therapy in combination with pembrolizumab in HR-positive HER2-negative breast cancer This study is designed to test how well radiation therapy in combination with pembrolizumab treats this type of cancer
The FDA has approved radiation therapy as a treatment option for this type of breast cancer
The FDA the US Food and Drug Administration has not approved pembrolizumab for this specific disease but it has been approved in the United Sates for other types of cancer
Pembrolizumab is a drug that may treat cancer by working with the immune system The immune system is the bodys natural defense against disease The immune system sends types of cells called T cells throughout the body to detect and fight infections and diseases including cancer For some types of cancer the T cells do not work as they should and are prevented from attacking the tumors Pembrolizumab is thought to work by blocking a protein in the T cells called PD-1 programmed death 1 which then allows these cells and other parts of the immune system to attack tumors
The combination of pembrolizumab and radiation therapy is investigational The study drug and radiation therapy when given separately work in different waysto help stop the cancer cells from growing and spreading However it is not known if giving the study drug and radiation therapy at the same time will have a better anti-cancer effect than giving each treatment on its own
In this research study the investigators are evaluating the safety and effectiveness of palliative radiotherapy radiation therapy in combination with pembrolizumab in HR-positive HER2-negative breast cancer This study is designed to test how well radiation therapy in combination with pembrolizumab treats this type of cancer
The FDA has approved radiation therapy as a treatment option for this type of breast cancer
The FDA the US Food and Drug Administration has not approved pembrolizumab for this specific disease but it has been approved in the United Sates for other types of cancer
Pembrolizumab is a drug that may treat cancer by working with the immune system The immune system is the bodys natural defense against disease The immune system sends types of cells called T cells throughout the body to detect and fight infections and diseases including cancer For some types of cancer the T cells do not work as they should and are prevented from attacking the tumors Pembrolizumab is thought to work by blocking a protein in the T cells called PD-1 programmed death 1 which then allows these cells and other parts of the immune system to attack tumors
The combination of pembrolizumab and radiation therapy is investigational The study drug and radiation therapy when given separately work in different waysto help stop the cancer cells from growing and spreading However it is not known if giving the study drug and radiation therapy at the same time will have a better anti-cancer effect than giving each treatment on its own
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