Researchers at Cancer Treatment Centers of America in suburban Chicago evaluating investigational medication for HER2-positive breast cancer

ZION — Cancer Treatment Centers of America® (CTCA) today announced it is enrolling patients in a clinical study designed to evaluate a potential new treatment option for patients with HER2-positive breast cancer. The hospital is the only center to offer the study north of Niles, Illinois, and is the closest location to Milwaukee, Wisconsin. The randomized pivotal study, called HER2CLIMB, will evaluate the investigational medication tucatinib in combination with standard treatments for patients with locally advanced or metastatic HER2-positive (HER2+) breast cancer, with or without brain metastases.

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 246,660 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 benefit from treatment with HER2-targeted therapies,” said Eric P. Winer, MD, Chair of the HER2CLIMB International Steering Committee and Professor of Medicine at Harvard Medical School, Director, Breast Oncology Center and Chief Strategy Office at Dana-Farber Cancer Institute in Boston, USA. “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.”

Historically, HER2-positive disease has been associated with shorter survival times as well as a higher risk of recurrence and CNS disease (brain metastases). Over the past two decades, the approvals of four targeted treatments (trastuzumab, pertuzumab, lapatinib, and ado-trastuzumab emtansine or T-DM1) have led to improved time to progression and survival rates of HER2+ patients. Yet there remains a need for new therapies.

“One of the weaknesses of many treatments for HER2+ breast cancer is that they do not cross the blood brain barrier well. Treatment options for HER2+ breast cancer patients with metastatic disease to the brain remain very limited. Fortunately, the HER2CLIMB study does not specifically exclude patients with brain metastases because the study drug, tucatanib, has promising preclinical data of both brain penetration and activity,” said Eugene Ahn, MD, Medical Director of Clinical Research and Medical Oncologist/Hematologist at CTCA® in Suburban Chicago. “CTCA is dedicated to providing new treatment options for all patients. We continue to explore and offer clinical trials that may advance the face of cancer care.”

Tucatinib is a HER2 inhibitor designed specifically to target and inhibit the growth of HER2-positive cancer cells. Tucatinib is an oral medication that can be taken at home. 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.

CTCA and other clinical sites across the U.S. are participating in HER2CLIMB with a goal to enroll approximately 480 participants. 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 three common therapies for the treatment of breast cancer– trastuzumab (Herceptin®), pertuzumab (Perjeta®) and T-DM1 (Kadcyla®). Patients may be able to participate in the HER2CLIMB study even if they have brain metastases. Eligible participants in HER2CLIMB 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 cancercenter.com/clinical-trials or HER2CLIMB.com. For more information, you may also visit clinicaltrials.gov, Identifier: NCT02614794.

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