Are you or a loved one currently facing metastatic breast cancer? Stand Up To Cancer (SU2C) is supporting a clinical trial that may benefit patients with ER+ breast cancers, a disease that to date is still responsible for a vast majority of breast cancer-related deaths.
One of the missions of this team is to better understand why immunotherapy combinations work—or fail to work—in treating ER+ breast cancer. Researchers on this team are studying new treatment combination strategies for ER+ breast cancer. These combinations are expected to increase the number of immune cells around the tumor and increase the concentration of specific protein tags on cancer cells. These proteins act as markers, allowing the immune system to target these cells for destruction.
If successful, the results from this trial and its molecular studies could have major implications for ER+ breast cancer treatment by transforming the tumor to be vulnerable to the immune system, and thereby increasing the survival rate from this common type of tumor.
We Need You
Why Your Participation Matters
Clinical trials are a critical step on the road to potential life-changing therapies; without them, new treatments for cancer cannot move forward. Your participation in this trial will help advance research and allow us to test the benefits and effectiveness of the outlined therapy combination in the treatment of ER+ metastatic breast cancer. This study has the potential to help inform future treatment approaches for other cancers as well.
Key Insights for Participants
There is no guarantee patients will benefit from this research study. It is possible that your condition will improve, but it is also possible there will be no effect on your condition or that your condition may continue to progress.
In patients with TP53-mutated ER+ breast cancer, this clinical trial will combine the MEK inhibitor cobimetinib with the PD-L1 inhibitor immunotherapy atezolizumab.
In patients with ER+ breast cancer who do not have a genetic mutation in the TP53 gene (about 60% of ER+ patients), the anti-MDM2 drug idasanutlin (which causes cells to age and consequently attract more T-cells) will be combined with immunotherapy atezolizumab.
In order to observe how these combinations may or may not work, this study requires participants to undergo two biopsies of one of the participant’s metastatic sites.
One biopsy will be conducted before beginning treatment in the study and the second 15 days after starting treatment in the study.
Patients with a diagnosis of clinical stage 4 IV invasive mammary carcinoma or unresectable locoregional recurrence of invasive mammary carcinoma that is ER+ and/or PR+ with previous exposure to hormone blockers in the metastatic setting. There are additional criteria that must be met to participate, or that may prevent a patient from participating.
Key criteria are summarized below and can be found in detail on ClinicalTrials.gov. Interested patients will need to review their medical histories with clinical trial patient coordinators before they can be accepted to participate in this trial.
18 years and older
Clinical stage IV invasive mammary carcinoma or unresectable locoregional recurrence of invasive mammary carcinoma that is ER+ and/or PR+
Eligible participants must have no major abnormalities in the laboratory blood work.
Participants must have had no more than 3 previous lines of chemotherapy in the metastatic setting.
Eligible participants must have no active health issues including autoimmune conditions, infections, and heart/liver/kidney or psychiatric issues.
Participants must have had no prior exposure to immunotherapies.
You play a vital role.
Here are the locations where you can participate in this clinical trial. If you, a loved one, or a patient are interested in enrolling and learning more about this study, please contact the patient coordinator. The patient coordinator is there to help you understand every aspect of the clinical trial process and can answer any questions you may have.
Once you contact the patient coordinator, he or she will start by reviewing your medical history with you to see whether you meet all the criteria to participate. The coordinator will then guide you through a review of the study and detailed “informed consent” documents that are required when you enroll in a clinical trial.
Nashville - Tennessee
Vanderbilt-Ingram Cancer Center
Patient Coordinator: Jannine Hewitt, RN
Find out if there's a trial for you. Reach out today.
Even if you do not meet the requirements for this trial, there may be other trials for you. Get started with the SU2C Clinical Trial Finder, a free and confidential cancer clinical trial matching and referral service.
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