Immunotherapy Combination Strategies in ER+ Metastatic Breast Cancer

Dr. Mayer obtained her medical degree from the Federal University of Sáo Paulo, Brazil in 1993. Thereafter, she came to the United States for her post-graduate training (internship, residency, chief-residency and hematology/oncology fellowship) at the University of Illinois at Chicago, between 1994 and 2001. During that time, Dr. Mayer received an American Society of Clinical Oncology (ASCO) Young Investigator Award in 2001 for her research project focused on the inhibitory effects of IFN-alpha in chronic myelogenous leukemia.

In September, 2003, Dr. Mayer was recruited to Vanderbilt University as an Assistant Professor of Medicine and member of the Breast Cancer Program of the NCI-designated Vanderbilt-Ingram Cancer Center (VICC). She successfully completed a Master of Science in Clinical Investigation (MSCI) Program at Vanderbilt University in May 2006. Since then, she displayed an impressively strong commitment to a career in patient-oriented clinical and translational research in breast cancer. Her research endeavors have been focused on 1) the identification of targetable pathways in breast cancer, 2) ErbB signaling and endocrine therapy resistance in estrogen receptor positive (ER+) breast cancers, 3) PI3K signaling and endocrine therapy resistance in ER+ breast cancers, 4) chemotherapy resistance in triple negative breast cancers, and 5) biomarker prediction of treatment response in human breast cancers. She has obtained several grants to fund her line of research, including a K23 Career Development Award, a Breast Cancer Research Foundation–American Association for Cancer Research (BCRF-AACR) Grant for Translational Breast Cancer Research, and co-leadership in three projects in two of the VICC Breast Cancer Specialized Program of Research Excellence (SPORE) Grants.

Dr. Mayer has been a Principal Investigator on more than 50 clinical trials, spanning from phase I through phase III trials. Of these, more than 10 are investigator-initiated trials (IITs), including two large Cooperative Group phase III trials through the Eastern Cooperative Oncology Group–American College of Radiology Imaging Network (ECOG-ACRIN) and a global Stand Up to Cancer (SU2C) / Translational Breast Cancer Research Consortium (TBCRC) / Novartis trial. In view of her clinical trial experience, she was appointed Chair of the Data Safety and Monitoring Committee (VICC DSMC) in 2010.

Nationally, aside from being an active member of the ECOG-ACRIN Breast Core Committee, and the VICC representative of the National Comprehensive Cancer Network (NCCN) Breast Cancer Panel of Experts, Dr. Mayer has been highly involved with the Translational Breast Cancer Research Consortium (TBCRC), and since 2009, she was appointed co-Chair of the TBCRC Endocrine Resistance Working Group (ERWG).

As a key component of the VICC Breast Cancer Program, Dr. Mayer has been the director of the Clinical Core of the VICC Breast Cancer SPORE and Clinical Team Leader of the Breast Cancer Program since 2008. In this capacity, Dr. Mayer oversees and coordinates the efforts of several physicians and full-time research support personnel, assisting with implementation and development of investigator-initiated, mechanism-based translational clinical trials, patient accrual, management, and monitoring of toxicity of patients on the trials. Under her leadership, the Breast Cancer Research Team is currently one of the top accruer of patients to VICC trials, and in 2014 she was appointed Co-Leader of the VICC Breast Cancer Program.

View Full Team

Meet the Team

Ingrid A. Mayer, MD, Vanderbilt University
Justin Balko, PharmD, PhD, Vanderbilt University
William Gradishar, MD, Northwestern University
Hope Rugo, MD, University of California, San Francisco
Melinda Sanders, MD, Vanderbilt University
Yu Shyr, PhD, Vanderbilt University
Jeffrey A. Sasman, MD, Northwestern University

Patient Advocate: Linda Horton

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About This SU2C Catalyst Clinical Trial

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.

Eligibility

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.

Gender:

Female

Age Range:

18 years and older

Diagnosis:

Clinical stage IV invasive mammary carcinoma or unresectable locoregional recurrence of invasive mammary carcinoma that is ER+ and/or PR+

Participate

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
P: 615-875-9636

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