E3108 A Phase II Prospective Trial Correlating Progression Free Survival with CYP2D6 Activity in Patients with Metastatic Breast Cancer Treated with Single Agent Tamoxifen
The purpose of this study is to learn more about the way that tamoxifen is broken down (or metabolized) in the body. One of the enzymes that is very important in this process is called CYP2D6. The level of the enzyme CYP2D6 differs from person to person and this may affect the way that tamoxifen is broken down. This may also affect how much benefit patient gets from taking it. This study will compare the different people who break down tamoxifen differently and look at how they benefit from the drug.
People with recurrent or metastatic breast cancer whose doctor has recommended treatment with tamoxifen may be eligible to join this study. Patients may not have received tamoxifen in the past.
Before joining this study participants will sign a consent form. Participants will have a physical exam, a review of medical history and medications, imaging of the tumor (with CT, MRI and a bone scan), and routine and research blood tests. During the study participants will take tamoxifen every day as long as the doctor feels it helps keep the cancer from growing and there are no serious side effects. Participants will continue to have physical exams, imaging scans and blood tests at regular intervals. Blood tests for research purposes will be repeated at the end of cycle 3 and at the completion of the study.
05/24/2013 04:02 AM