Atezolizumab + Stereotactic Radiation for Breast Cancer with Brain Tumor
What You Need to Know Before You Apply
What is the purpose of this trial?
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:* Atezolizumab* Stereotactic radiosurgery (SRS)
Do I have to stop taking my current medications for the trial?
Yes, you must stop taking any systemic therapy at least 14 days before starting the trial treatment. However, you can continue or start bisphosphonate therapy during the study.
Is the combination of Atezolizumab and stereotactic radiation generally safe for humans?
Atezolizumab, when combined with stereotactic radiation, has been studied in different cancers and is generally well tolerated. In a study with lung cancer patients, the treatment was well tolerated, and the maximum tolerated dose of Atezolizumab was established. Additionally, Atezolizumab has been approved for use in various cancers, indicating its safety profile has been evaluated in multiple settings.12345
How is the treatment of Atezolizumab combined with stereotactic radiation unique for breast cancer with brain tumors?
This treatment is unique because it combines Atezolizumab, an immune checkpoint inhibitor that boosts the body's immune response against cancer, with stereotactic radiation, a precise form of radiation therapy. This combination aims to enhance the effectiveness of treatment for breast cancer with brain tumors, a condition with limited standard treatment options.12678
What data supports the effectiveness of the treatment Atezolizumab combined with Stereotactic Radiation for Breast Cancer with Brain Tumor?
Research shows that combining atezolizumab, an immune checkpoint inhibitor, with radiation therapy can be safe and potentially effective, as seen in studies with other cancers like non-small cell lung cancer and bladder cancer. These studies suggest that the combination may enhance the body's immune response against tumors, although more research is needed to confirm these effects specifically for breast cancer with brain tumors.126910
Who Is on the Research Team?
Nancy Lin
Principal Investigator
Dana-Farber Cancer Institute
Are You a Good Fit for This Trial?
This trial is for adults with triple-negative breast cancer that has spread to the brain. They must have stable brain metastases treatable with SRS, controlled steroid use, measurable disease outside the brain, and normal organ function. Pregnant women or those on high-dose steroids, previous anti-PD-1/PD-L1 therapy, or with certain medical conditions are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive atezolizumab intravenously once every 3 weeks and stereotactic radiosurgery (SRS) begins within 14 days after brain MRI
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored for overall survival
What Are the Treatments Tested in This Trial?
Interventions
- Atezolizumab
- Stereotactic Radiosurgery (SRS)
Atezolizumab is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Dana-Farber Cancer Institute
Lead Sponsor
Genentech, Inc.
Industry Sponsor
Ashley Magargee
Genentech, Inc.
Chief Executive Officer since 2024
MBA from Harvard University, BA from Princeton University
Levi Garraway
Genentech, Inc.
Chief Medical Officer since 2021
MD, PhD