Clinical Trials

H-20464 A Phase Two Trial of Lapatinib and Trastuzumab with or without Endocrine Therapy in Locally Advanced HER2 Overexpressing Breast Cancer Patients

Volunteers are being sought for a study enrolling women with advanced breast cancer. This study looks at whether or not an investigational drug called lapatinib will help to reduce breast tumors when given as neoadjuvant therapy. We will compare lapatinib to lapatinib plus another drug called trastuzumab (herceptin). The treatment will last for 12 weeks. Trastuzumab is an approved treatment for advanced breast cancer. Lapatinib is not yet approved by the FDA for neoadjuvant treatment of breast cancer.  It was approved by the FDA  in combination with another cancer drug called Xeloda for the treatment of advanced, metastatic breast cancer that is HER2 positive. The study will look at changes that may occur within the tumor tissue.

Patient population:
Women diagnosed with advanced breast cancer that is HER2 positive.

Patients will receive free study medications and will be reimbursed for expenses associated with returning to the clinic for additional tumor biopsies.

For more information, contact the Lapatinib/Herceptin study team at 713-798-1986.