A Phase III Randomized, Double Blind Placebo Controlled Study of BKM120 with Fulvestrant, in Postmenopausal Women with Hormone Receptor-positive HER2-negative Locally Advanced or Metastatic Breast Cancer which Progressed on or After Aromatase Inhibitor Treatment
The purpose of this study is to determine if the drug BKM120 when given with or without fulvestrant (FaslodexÂ®) is a safe and effective treatment for postmenopausal women with progressive hormone receptor-positive breast cancer. BKM120 belongs to a class of drugs called PI3-kinase or â??PI3Kâ?? inhibitors. The PI3K protein is part of a pathway that causes growth of some cancer cells. If PI3K is blocked (or inhibited) the pathway will not function and this may stop cancer growth. About 30% of breast cancers tumors contain changes to the PI3K pathway that may make them good targets for treatment with a PI3K-inhibitor like BKM120. In this study treatment with BKM120 will be limited to patients whose tumors have this change. Therefore your tumor will be tested for these changes to find out if you are eligible to receive BKM120.Fulvestrant is a hormone therapy that is FDA approved for the treatment of women with hormone positive breast cancer.
This study is for postmenopausal patients who have advanced breast cancer that has progressed on or after treatment with aromatase inhibitors.
If you agree to participate in the study, you would sign a consent form. You will have a series of tests to make sure it is safe for you to join the study. We will also request a sample of previously collected tumor tissue to test for the changes in the PI3K pathway described above. You may begin treatment with fulvestrant while your tumor is being tested. Fulvestrant is an injection given in the clinic every 4 weeks; an extra loading dose is given 2 weeks after the first dose. If your tumor is found to have changes in the PI3K pathway, you may continue in the study. At that time you will be randomly assigned to receive BKM120 or a placebo with the fulvestrant. The study pills (BKM120 or placebo) are taken daily, and neither you nor your doctor will know which you are taking. You may continue on the study as long as you are tolerating the study drugs and your cancer is responding. You will be asked to complete quality of life questionnaires and other research blood tests during the study.
06/19/2013 04:02 AM