Metastatic gpNMB Over-expressing Triple Negative Breast Cancer Clinical Trial
Official title:
A Randomized Multicenter Pivotal Study of CDX-011 (CR011-vcMMAE)in Patients With Metastatic, gpNMB Over-Expressing, Triple Negative Breast Cancer (The METRIC Study)
The main purpose of this study is to see whether CDX-011 (glembatumumab vedotin, an antibody-drug conjugate) is effective in treating patients who have advanced Triple-Negative Breast Cancer (TNBC), and whose tumor cells make a protein called glycoprotein NMB (gpNMB), which CDX-011 binds to. The study will also further characterize the safety of CDX-011 treatment in this patient population.
CDX-011 consists of an antibody attached to a drug, monomethyl auristatin E (MMAE), that can
kill cancer cells. The antibody delivers the drug to cancer cells by attaching to a protein
called glycoprotein NMB (gpNMB) that is expressed on the cancer cell. The MMAE is then
released inside of the cell, where it interferes with cell growth and may lead to cell death.
This study will examine the efficacy and safety of CDX-011 in patients with advanced TNBC
that makes the gpNMB protein. The effect of CDX-011 will be compared to treatment with
capecitabine.
Eligible patients who enroll in the study will be randomly assigned (by chance) to receive
treatment with CDX-011 or with capecitabine. For every three patients enrolled, two will
receive CDX-011 and one will receive treatment with capecitabine. All patients enrolled in
the study will be closely monitored to determine if their cancer is responding to treatment
and for any side effects that may occur.
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