Do you have HER2-positive breast cancer that may have spread to other parts of your body? You may be able to participate in a research study to find out if the combination of two anti-cancer study drugs is a safe and effective treatment for adults with advanced HER2-positive breast cancer. Reimbursement for study visits is provided.
Breast cancer that has spread to other parts of the body can be difficult to treat. The purpose of this study is to find out if the combination of two anti-cancer study drugs (tucatinib and trastuzumab deruxtecan) is a safe and effective treatment for adults with advanced HER2-positive breast cancer. Tucatinib and trastuzumab deruxtecan are both FDA-approved for the treatment of advanced HER2-positive breast cancer, but the combination of the two drugs is considered investigational.
COULD THIS STUDY BE RIGHT FOR YOU?
- Females and males aged 18 and up
- Diagnosed with HER2-positive breast cancer that may have spread to other parts of your body
- Previously treated with two or more anti-HER2-based drug regimens in a metastatic setting
WHAT PARTICIPANTS CAN EXPECT
Eligible participants will have multiple in-person study visits. Participants will receive trastuzumab deruxtecan by IV every three weeks and will take a tucatinib pill by mouth twice per day. Participants will also have physical exams, provide blood samples, undergo CT scans, and have other tests and assessments. The study will also include an end-of-treatment visit and follow-up visits/phone calls after you have stopped taking the study drugs.
IRB:20201928 - A Single Arm, Open Label Phase 2 Study of Tucatinib in Combination with Trastuzumab Deruxtecan in Subjects with Previously Treated Unresectable Locally-Advanced or Metastatic HER2+ Breast Cancer
MEET THE RESEARCHER
Adam M. Brufsky, MD, PhD, is Associate Chief and Professor of Medicine in the Division of Hematology/Oncology in the Department of Medicine at the University of Pittsburgh and Associate Director of Clinical Investigation for the University of Pittsburgh Cancer Institute. Dr. Brufsky received his medical degree and doctorate from the University of Connecticut School of Medicine. He completed his residency in internal medicine at Brigham and Women's Hospital, Harvard Medical School and a fellowship in medical oncology and bone marrow transplantation at the Dana-Farber Cancer Institute. Dr. Brufsky’s research interests include novel therapies for breast cancer, bone-breast cancer interactions and therapeutics, and the molecular biology of metastatic breast cancer.