HER2 Breast Cancer
About 15 to 30% of breast cancers produce too much HER2 (human epidermal growth factor receptor 2) protein1. Overproduction of the HER2 protein can cause uncontrolled growth of breast cells, leading to tumors.
HER2+ breast cancers are normally treated with drugs that specifically target the HER2 protein in breast cancer cells. These treatments work by blocking breast cancer cells from receiving growth signals or by interfering with the proteins that cause breast cancer cells to grow. Treatments may be one drug alone or a combination of drugs.
Existing drug treatments have limitations in their effectiveness and each person responds to treatment differently. In an effort to improve HER2+ breast cancer drugs, research is being done to better understand treatments that target HER2+ breast cancer. It is hoped that this research may lead to treatments that better help people whose breast cancer is not responding to existing HER2+ agents orwhose breast cancer has progressed on prior treatments.
About The NALA Study
The NALA study is a clinical research study for adults who have received at least two previous HER2-directed treatments for metastatic breast cancer (breast cancer that has spread to other parts of the body).
The purpose of this clinical research study is to test the safety and benefit of an investigational drug called neratinib when given with an approved breast cancer drug called capecitabine. The NALA study will test to see if this investigational combination is the same or better at preventing further progression of breast cancer when compared to another combination of lapatinib and capecitabine.
Both neratinib and lapatinib are drugs that target the HER2 protein in breast cancer cells. Capecitabine is an oral (by mouth) chemotherapy that is approved to treat metastatic breast cancer. The combination of lapatinib and capecitabine is not approved in all countries where this study will be conducted and will be considered investigational.
About 600 people around the world will participate in this clinical research study. Study participants will be put into one of two treatment groups:
Participants have a 50-50 chance (like the flip of a coin) of being assigned to either study treatment group. All of the study drugs taken during the NALA study will be taken orally.