Atezolizumab + Stereotactic Radiation in Triple-negative Breast Cancer and Brain Metastasis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03483012|
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : December 13, 2019
This research study is studying the combination of a drug called atezolizumab and a radiation procedure called stereotactic radiosurgery (SRS) as a possible treatment for triple-negative breast cancer that has spread to the brain.
The interventions involved in this study are:
- Stereotactic radiosurgery (SRS)
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Atezolizumab Procedure: Stereotactic radiosurgery (SRS)||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.
The FDA (the U.S. Food and Drug Administration) has not approved atezolizumab for this specific disease but it has been approved for other uses.
Atezolizumab is a protein that affects the immune system by blocking the PD-L1 pathway. The PD-L1 pathway controls the body's natural immune response, but tumors can interrupt this pathway and partially resist or escape the immune system. By blocking the PD-L1 pathway, Atezolizumab may help the immune system identify and catch tumor cells.
Stereotactic radiosurgery (SRS) is a standard procedure used to treat patients with cancer in the brain. SRS uses many precisely focused radiation beams to treat tumors. It is not surgery in the traditional sense because there's no incision. Instead, SRS uses 3-D imaging to target high doses of radiation to the affected area with minimal impact on the surrounding healthy tissue. Like other forms of radiation, SRS works by damaging the DNA of the targeted (tumor) cells. The affected cells then lose the ability to reproduce, which causes tumors to shrink.
When given separately, atezolizumab and SRS, work in different ways to help stop cancer cells from growing and spreading. However, it is not known if giving atezolizumab and SRS at the same time will have a better effect than giving each treatment on its own. It is hoped that SRS treatment will damage cancer cells and make them more visible to the immune system.
The researchers conducting this study are testing to see whether giving SRS with atezolizumab may boost the body's immune response to cancer, and therefore improve upon the effects of either SRS or atezolizumab given alone.
In this research study, the investigators will measure the length of time that the participant receive this study intervention without the disease getting worse. The investigators will also look at how well the disease responds to atezolizumab and SRS as well as the safety of the combination.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Atezolizumab in Combination With Stereotactic Radiation for Patients With Triple-negative Breast Cancer and Brain Metastasis|
|Actual Study Start Date :||May 1, 2018|
|Estimated Primary Completion Date :||September 30, 2021|
|Estimated Study Completion Date :||September 30, 2025|
Experimental: Atezolizumab + Stereotactic radiosurgery (SRS)
Atezolizumab is a protein that affects your immune system by blocking the PD-L1 pathway
Other Name: Tecentriq
Procedure: Stereotactic radiosurgery (SRS)
Stereotactic radiosurgery (SRS) is a standard procedure used to treat patients with cancer in the brain. SRS uses many precisely focused radiation beams to treat tumors
- Progression Free Survival [ Time Frame: 24 weeks ]Assessed using RANO-BM criteria
- Extracranial Objective Response Rate [ Time Frame: 24 weeks ]Assessed by RECIST 1.1
- Extracranial Objective Response Rate [ Time Frame: 24 weeks ]Assessed by immune-related response criteria (irRC)
- Progression free survival [ Time Frame: 24 weeks ]Assessed by RECIST 1.1
- Clinical Benefit Rate [ Time Frame: 16 and 24 weeks ]defined as CR, PR and stable disease
- Overall Survival [ Time Frame: 2 years ]evaluate the overall survival (OS) of atezolizumab in combination with SRS in patients with TNBC and brain metastasis
- Patient-Reported Outcome [ Time Frame: 2 years ]Evaluated by MDASI-BT assessment.
- Development of radiation necrosis [ Time Frame: 2 years ]Assessed by neuroradiology assessment or dual-phase PET-CT studies
- Investigator-Assessed Neurological Evaluation [ Time Frame: 2 years ]Evaluated by physician assessed Neurological Assessment in Neuro-Oncology (NANO) scale
- Dose Limiting Toxicity [ Time Frame: First dose of atezolizumab until Cycle 3 Day 1 ]NCI CTCAE, Version 4.0
- Abscopal response rate [ Time Frame: 2 years ]According to abscopal response definition
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): NCT03483012
|Contact: Kelley Cassidyfirstname.lastname@example.org|
|United States, Massachusetts|
|Dana-Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Kelley Cassidy 617-632-3548 email@example.com|
|Principal Investigator: Nancy U Lin, MD|
|Principal Investigator:||Nancy U Lin, MD||Dana-Farber Cancer Institute|