A Phase 1b/2 Randomized Study of MEDI-573 in Combination with an Aromatase Inhibitor (AI) Versus AI Alone in Women with Metastatic Breast Cancer (MBC)
The purpose of this study if to find out what effects (good and bad) the combination of the investigational drug MEDI-573 with an aromatase inhibitor (AI) has on you and your breast cancer. AIs are one of the standard treatments approved for hormone receptor positive metastatic breast cancer. MEDI-573 is an antibody that has been created in the laboratory where tests show that it may make AIs more effective. An antibody attaches to certain proteins in your body needed to make cancer cells grow and survive. MEDI-573 is being studied to see if it slows the growth and spread of breast cancer cells.
Postmenopausal women with hormone receptor positive metastatic breast cancer, who have not received any treatment for their metastatic disease may be eligible for this study.
You will sign consent and have testing, including an electrocardiogram and scans to make sure that it is safe for you to participate in the trial. You will then be randomized to receive either standard treatment with an AI alone or to receive the AI along with the investigational drug MEDI-573. To be randomized means to be picked by chance, like flipping a coin. You and your doctor will not be able to choose your treatment. If you are randomized to receive MEDI-573, it will be given by intravenous infusion in the clinic every 21 days. You will come to clinic for weekly visits the first 3 weeks you are on study to meet with study staff and for standard and research lab tests. After this, you will come to clinic every 3 weeks. Repeat scans to see how your cancer is responding will be done about every 9 weeks on study. You will stay on study as long as you are tolerating your treatment and your cancer is stable or responding.
05/21/2013 04:02 AM