ECU Physicians, the clinical practice of the Brody School of Medicine at East Carolina University (ECU), is enrolling patients in a nationwide clinical study designed to evaluate a potential new treatment option for patients with HER2-positive breast cancer.
Called HER2CLIMB, the study will evaluate the medication tucatinib in combination with standard treatments for patients with locally advanced or metastatic HER2-positive breast cancer, with or without brain metastases. Tucatinib is an oral medication that can be taken at home.
HER2-positive breast cancer is a type of breast cancer that tests positive for a protein called human epidermal growth factor receptor 2 (HER2). HER2 promotes the aggressive spread of cancer cells. The American Cancer Society estimates that 20 to 25 percent of the approximately 234,000 annual breast cancer diagnoses in the U.S. are HER2-positive.
“Patients who have been diagnosed with HER2-positive breast cancer and whose cancer has metastasized may benefit from treatment with HER2-targeted therapies,” said Eric P. Winer, M.D., chair of the HER2CLIMB International Steering Committee, professor of medicine at Harvard Medical School and director of the Breast Oncology Center at Dana-Farber Cancer Institute in Boston.
“This investigational medication is designed to inhibit the activity of HER2 and is being evaluated in combination with other approved therapies. The HER2CLIMB trial will enroll patients with HER2-positive breast cancer that has spread to the brain, a patient population that is often excluded from clinical trials,” Winer added.
Historically, HER2-positive disease has been associated with shorter survival times as well as a higher risk of recurrence and brain metastases. Over the past two decades, the approvals of four other targeted treatments have led to slower progression of the disease and improved survival rates for HER2-positive patients.
Yet the need for new therapies remains, according to ECU oncologist Dr. Mahvish Muzaffar.
“Brody is dedicated to advancing new treatment options for advanced HER2-positive breast cancer through studies like HER2CLIMB,” Muzaffar said. “Despite treatment advances, there is still a significant need for new therapies that can impact the lives of patients with advanced HER2-positive breast cancer – including cancer that has spread to the brain – and that can be tolerated for long periods of time.”
The safety and effectiveness of tucatinib has not yet been established. As with other anti-cancer treatments, this investigational treatment may or may not provide benefit and may cause side effects.
To be eligible for this study, patients must have locally advanced or metastatic HER2-positive breast cancer. In addition, patients must have already been treated with four common breast cancer therapies – taxane (Taxotereâ or Taxolâ), trastuzumab (Herceptinâ), pertuzumab (Perjetaâ), and T-DM1 (Kadcylaâ).
Enrolled participants will receive standard, approved treatments. In addition, they may also receive the investigational medication tucatinib.
To learn more about the HER2CLIMB study, including eligibility criteria, visit HER2CLIMB.com or call the Leo Jenkins Cancer Center at 252-744-1888.