Cancer Treatment Centers of America 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 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 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. More recently, neratinib (Nerlynx) has been approved for the adjuvant treatment of HER2+ breast cancer. Yet there remains a need for new therapies.

“We’re excited to expand our clinical offerings for advanced stage breast cancer by offering the HER2CLIMB study,” says Dr. Ricardo Alvarez, Medical Director of the Breast Cancer Center and Director of Cancer Research. “What makes this study more unique is that patients who have brain metastases can be candidates. We will continue to look for more ways to expand treatment options, better patient experience and improve quality of life.”
 
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. Eligible participants in HER2CLIMB will receive standard, approved treatments. In addition, you may also receive the investigational medication tucatinib.
                                                                                                                 
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.