Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04837209
Status:
RECRUITING
Last Update Posted:
2023-11-15
First Post:
2021-04-02
Brief Title:
Radiation Immunotherapy and PARP Inhibitor in Triple Negative Breast Cancer
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
A Phase II Study of NirAparib Dostarlimab and Radiotherapy in Metastatic PD-L1 Negative or Immunotherapy-Refractory Triple-Negative Breast Cancer NADiR
Status:
RECRUITING
Status Verified Date:
2024-09
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:
NADiR
Brief Summary:
This research study is looking to see whether the combination of Dostarlimab and Niraparib plus Radiation Therapy RT is safe and effective in participants with metastatic triple negative breast cancer
The names of the study treatment involved in this study are
Dostarlimab
Niraparib
Radiation Therapy RT which is given per standard of care
The names of the study treatment involved in this study are
Dostarlimab
Niraparib
Radiation Therapy RT which is given per standard of care
Detailed Description:
This is an open-label phase II study that will evaluate how safe and well the combination of niraparib dostarlimab and Radiation Therapy RT works in metastatic triple negative breast cancer
Niraparib is a type of drug called a PARP inhibitor which blocks DNA the genetic material of cells damage from being repaired or may prevent damage from occurring in the first place In cancer treatment inhibiting PARP may help kill cancer cells by not allowing the cancer cells to repair its DNA damage or prevent DNA damage associated with metastatic triple negative breast cancer from occurring
Dostarlimab is a type of immunotherapy It is believed to work by inhibiting stopping a protein called PD-1 from working The PD-1 protein controls parts of the immune system the system in a persons body that fights against diseases by shutting down certain immune responses that are responsible for recognizing and destroying cancer cells
The investigators believe that dostarlimab may inhibit the PD-1 protein on triple negative breast cancer cells thus allowing the immune cells to recognize and destroy cancer cellsRadiation therapy is a standard-of-care treatment that is given to stop the growth of tumors Radiation therapy can also stimulate the immune system which leads to the destruction of tumor cells in the treated areas Combining radiation therapy with anti-cancer drugs like dostarlimab and niraparib may increase the ability of the immune system to control or destroy cancer cells throughout the body
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits
Participants will receive the study drugs for up to 2 years or until their triple negative breast cancer worsens Participants will then be followed for up to 5 years
It is expected that about 32 people will take part in this research study
The FDA has not approved niraparib for metastatic triple negative breast cancer but it has been approved for other uses
The US Food and Drug Administration FDA has not approved dostarlimab as treatment for any disease
Niraparib is a type of drug called a PARP inhibitor which blocks DNA the genetic material of cells damage from being repaired or may prevent damage from occurring in the first place In cancer treatment inhibiting PARP may help kill cancer cells by not allowing the cancer cells to repair its DNA damage or prevent DNA damage associated with metastatic triple negative breast cancer from occurring
Dostarlimab is a type of immunotherapy It is believed to work by inhibiting stopping a protein called PD-1 from working The PD-1 protein controls parts of the immune system the system in a persons body that fights against diseases by shutting down certain immune responses that are responsible for recognizing and destroying cancer cells
The investigators believe that dostarlimab may inhibit the PD-1 protein on triple negative breast cancer cells thus allowing the immune cells to recognize and destroy cancer cellsRadiation therapy is a standard-of-care treatment that is given to stop the growth of tumors Radiation therapy can also stimulate the immune system which leads to the destruction of tumor cells in the treated areas Combining radiation therapy with anti-cancer drugs like dostarlimab and niraparib may increase the ability of the immune system to control or destroy cancer cells throughout the body
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits
Participants will receive the study drugs for up to 2 years or until their triple negative breast cancer worsens Participants will then be followed for up to 5 years
It is expected that about 32 people will take part in this research study
The FDA has not approved niraparib for metastatic triple negative breast cancer but it has been approved for other uses
The US Food and Drug Administration FDA has not approved dostarlimab as treatment for any disease
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?:
False
Is an FDA AA801 Violation?:
None