CDX011-04, A Randomized Multicenter Pivotal Study of CDX-011 in Patients with Metastatic, gpNMB Over-expressing, Triple Negative Breast Cancer (The METRIC Study)
Cancer - Breast
Principal Investigator: Randa Loutfi, MD
The main purpose of this study is to see whether CDX-011 is effective in treating patients who have advanced triple negative breast cancer (tumors lacking expression of estrogen, progesterone and HER2 receptors), and whose tumor cells make a protein called glycoprotein NMB, which CDX-011 binds to. The study will also further characterize the safety of CDX-011 treatment in this patient population.
18 years and older; Diagnosed with metastatic (cancer that has spread) triple negative (does not have hormone receptors ER or PR or HER2) breast cancer; breast cancer confirmed to express gpNMB; no more than two prior chemotherapy treatments for advanced breast cancer; prior chemo must have contained an anthracycline (e.g. doxorubicin or Doxil) and a taxane (e.g. Taxol)