Phase II PEMBROLIZUMAB + PALLIATIVE RADIOTHERAPY IN BC
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|ClinicalTrials.gov Identifier: NCT03051672|
Recruitment Status : Recruiting
First Posted : February 14, 2017
Last Update Posted : May 14, 2018
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
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Breast Cancer||Drug: Pembrolizumab Radiation: Palliative radiotherapy||Phase 2|
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 U.S. 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 body's 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study Of Pembrolizumab In Combination With Palliative Radiotherapy For Metastatic Hormone Receptor Positive Breast Cancer|
|Actual Study Start Date :||April 14, 2017|
|Estimated Primary Completion Date :||August 25, 2020|
|Estimated Study Completion Date :||August 25, 2024|
Experimental: Pembrolizumab With Radiation
Pembrolizumab binds to PD-1, an inhibitory signaling receptor expressed on the surface of activated T cells, and blocks the binding to and activation of PD-1 by its ligands, which results in the activation of T-cell-mediated immune responses against tumor cells
Other Name: Keytruda
Radiation: Palliative radiotherapy
Treatment to shrink a cancer, slow down its growth, or control symptoms
- Overall Response Rate [ Time Frame: 2 years ]
- Immune Response Rate [ Time Frame: 2 years ]
- Clinical Benefit Response Rate [ Time Frame: 2 years ]
- Progression Free Survival [ Time Frame: 2 years ]
- Absolute Risk Reduction [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03051672
|Contact: Sara Tolaney, MD||617-632-2335||Sara_Tolaney@dfci.harvard.edu|
|United States, Massachusetts|
|Dana-Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Sara Tolaney, MD 617-632-2335 Sara_Tolaney@dfci.harvard.edu|
|Principal Investigator: Sara Tolaney, MD|
|Principal Investigator:||Sara Tolaney, MD||Dana-Farber Cancer Institute|