National Institution for Breast Cancer Research

Will adding a new drug to the standard regimen for advanced breast cancer improve the effectiveness of treatment?

Janice Lu, MD, PhD, Director, Breast Medical Oncology Program, serves as the national principal investigator for the National Surgical Adjuvant Breast and Bowel Project (NSABP) FB-7 clinical trial. For more than 20 years, Stony Brook has been a member of NSABP, which is a large cooperative group that includes more than 200 U.S. and international cancer centers. The group collaborates with the National Cancer Institute. Dr. Lu coordinates 120 sites in the U.S. for this clinical trial.

“The study measures the efficacy of a new drug called neratinib as a neoadjuvent therapy for women with locally advanced breast cancer. The goal is to help patients better respond to treatment. Neratinib is an antibody against the receptor in HER-2 (human epidermal growth factor receptor 2). HER-2 promotes the growth of cancer cells. In one of about every five breast cancers, the cancer cells make an excess of HER-2 due to a gene mutation. HER-2 breast cancers tend to be very aggressive and responsive
to targeted treatment.

“We are looking at different ways to use neratinib with standard treatment,” says Dr. Lu. “Is neratinib combined with another anti-HER-2 antibody better than just the one?
Are there other more effective combinations?”

So far says Dr. Lu, the preliminary results are promising. If the combination of neratinib and Herceptin® is successful, then oncologists will begin to use the two together in the front-line setting to give patients the highest chance of a good response and durable remission. “The newchemotherapy regimen could offer more highly tailored treatments for the individual patient, better survival rates and less chance for recurrence,” says Dr. Lu.