Have you been diagnosed with hormone receptor-positive, HER-2 negative breast cancer that has spread to other parts of your body? Has your disease worsened during or after treatment with a CDK4/6 inhibitor? If so, you may be able to participate in a research study to compare the effects of experimental drug treatment versus standard treatment on you and your breast cancer.
Metastatic or advanced breast cancer is cancer that has spread outside of the breast and lymph nodes to other parts of the body. Women with advanced hormone-receptor positive, HER-2 negative breast cancer are often treated with a CDK4/6 inhibitor such as palbociclib, ribociclib, or abemaciclib, but cancer sometimes progresses despite this type of therapy.
The purpose of this study is to help researchers find out if different cancer immunotherapy (CIT) combinations are safe and effective treatments for people with advanced HER-2 negative, hormone receptor positive breast cancer that spread during or following a CDK4/6 inhibitor. Cancer immunotherapy is treatment that uses the body’s own immune system to fight disease. Researchers hope their findings will lead to better treatments for people with breast cancer in the future.
COULD THIS STUDY BE RIGHT FOR YOU?
- Women age 18 and up
- Diagnosed with hormone receptor-positive, HER-2 negative breast cancer that has spread to other parts of your body (advanced disease)
- Disease has worsened during or after treatment with a CDK4/6 inhibitor, such as palbociclib, abemaciclib, or ribociclib
WHAT PARTICIPANTS CAN EXPECT
Participation involves undergoing an initial screening assessment to be sure you are eligible to participate in the study. Tests and assessments include a physical exam, electrocardiogram (ECG), blood, urine, and tissue samples, and a CT (computed tomography), MRI (magnetic resonance imaging), PET (positron emission tomography) scan, or bone scan.
Qualified participants will be randomly assigned (like the flip of a coin) to a treatment group. Some people will receive standard hormone therapy and some people will receive cancer immunotherapy.
IRB: 20171475- A PHASE Ib/II, OPEN-LABEL, MULTICENTER, RANDOMIZED UMBRELLA STUDY EVALUATING THE EFFICACY AND SAFETY OF MULTIPLE IMMUNOTHERAPY-BASED TREATMENT COMBINATIONS IN PATIENTS WITH HORMONE RECEPTOR-POSITIVE HER2-NEGATIVE BREAST CANCER (MORPHEUS-HR+ BREAST CANCER)
MEET THE RESEARCHER
Leisha Emens, MD, PhD, is Professor of Medicine at the University of Pittsburgh, Co-Leader of the Hillman Cancer Immunology and Immunotherapy Program, and Director of Translational Immunotherapy for the Women's Cancer Research Center at Magee Women's Hospital. Dr. Emens received her MD-PhD from Baylor College of Medicine and completed her residency training in Internal Medicine at the University of Texas at Southwestern before moving to Johns Hopkins for a fellowship in Medical Oncology and Hematology. Dr. Emens specializes in cancer immunotherapy, and her research focuses on the development and implementation of breast cancer immunotherapies in combination with traditional anticancer therapies and newer targeted therapies.