Community cancer clinics across the entire Advocate Aurora Health system have joined a clinical trial evaluating a potential combination therapy to treat patients with high-risk human epidermal growth factor receptor 2 (HER2)-positive breast cancer.
The study is the first to jointly open at all of Advocate Aurora Health’s National Cancer Institute (NCI) Community Oncology Research Program (NCORP) sites in both Illinois and Wisconsin.
The clinical trial compares the standard treatment of a combination drug called T-DM1 to treatment with T-DM1 plus a newer anti-HER2 drug called tucatinib in preventing a person’s cancer from returning.
“T-DM1 is a combination of a monoclonal antibody called trastuzumab and a chemotherapy drug called DM1,” said hematologist and oncologist Rubina Qamar, MD, Advocate Aurora Research Institute’s principal investigator for the study. “Monoclonal antibodies, such as trastuzumab, are designed to attach to specific molecules, or receptors, on the surface of a cancer cell – in this case, HER2 receptors – helping deliver a targeted anti-cancer treatment, such as chemotherapy. Tucatinib is a newer anti-HER2 and is effective even if the cancer has spread to the brain.”
Tucatinib is already approved by the U.S. Food and Drug Administration for treating widespread breast cancer but not for early breast cancer.
When breast cancer cells have higher-than-normal levels of the growth-promoting protein called HER2, doctors describe the breast cancer as HER2-positive. These types of breast cancers tend to grow and spread faster than other types of breast cancer. HER2-positive breast cancer represents about 15% of invasive breast cancers.
“The study is enrolling patients that have already undergone chemotherapy, targeted therapies and surgery to remove the cancer, and are found to have viable cancer in the breast tissue that was removed,” Dr. Qamar said. “These patients are high risk for their breast cancer recurring. Researchers are searching for investigational treatments, such as this, that may be able to successfully decrease the chance of cancer returning without increasing the toxicity to the patient.”
Researchers plan to enroll more than 1,000 participants across the country in the clinical trial, “T-DM1 and tucatinib compared with T-DM1 alone in preventing relapses in people with high risk HER2-positive breast cancer, the CompassHER2 RD Trial.”
Following the 2018 merger of Illinois-based Advocate Health Care and Wisconsin-based Aurora Health Care, the health system began the process of integrating its Illinois cancer clinics into the existing Aurora NCORP network of community cancer clinics in Wisconsin. In 2019, NCI awarded Advocate Aurora a six-year, $10.2 million grant to expand its NCORP program to its community cancer clinics in Illinois, with the goal of providing patients increased access to clinical trials at the various Chicago and suburban area clinics that are part of the Advocate Aurora system.
“Advocate Aurora Research Institute is proud to be able to offer this important clinical trial, through our partnership with NCORP, at all of our community cancer clinics in Illinois and Wisconsin,” said Katie Wozniak, director of clinical trials research for oncology and neurosciences at the Research Institute. “By expanding our NCORP network, Advocate Aurora is able to bring cancer clinical trials to people in their own communities, instead of restricting them solely to major research institutions.”
The CompassHER2 RD study is led by Alliance for Clinical Trials in Oncology, a cooperative research group that designs and conducts clinical trials under the sponsorship of NCI.
To learn more about Advocate Aurora’s research, visit advocatehealth.org/research.