ECU to enroll breast cancer patients in landmark treatment study

The Brody School of Medicine at East Carolina University is enrolling patients in the HER2CLIMB nationwide study on medication for advanced or metastatic HER2-positive breast cancer. File photo courtesy of East Carolina University Health Sciences, Brody School of Medicine.

 GREENVILLE –  In North Carolina, breast cancer is the second leading cause of death for women.

Each year, more than 6,000 North Carolina women will be diagnosed with breast cancer and more than 1,000 will die from the disease, according to the N.C. Department of Health and Human Services.

In North Carolina, women have a one-in-eight lifetime risk of developing breast cancer. It’s not just in this state where women are facing diagnosis and treatment discussions. According to the American Cancer Society, approximately 252,710 new cases are expected to be diagnosed in 2017 with 40,610 women expected to die from the disease this year.

Clinical studies and treatment options are valuable in helping women battling breast cancer. ECU Physicians, the clinical practice of the Brody School of Medicine at East Carolina University, are enrolling patients in a nationwide clinical study designed to evaluate a potential new treatment option for patients with HER2-positive breast cancer.

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.

Called HER2CLIMB, the nationwide study will evaluate the medication tucatinib, an oral medication that can be taken at home, in combination with standard treatments for patients with locally advanced or metastatic HER2-positive breast cancer, with or without brain metastases.

“Patients who have been diagnosed with HER2-positive breast cancer and whose cancer has metastasized 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,” he 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,” said Muzaffar. “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 (Taxotere® or Taxol®), trastuzumab (Herceptin®), pertuzumab (Perjeta®), and T-DM1 (Kadcyla®).

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 or call the Leo Jenkins Cancer Center in Greenville at 252-744-1888.