Researchers at Cleveland Clinic are participating in a randomized multicenter pivotal study of CDX-011 for patients with metastatic, glycoprotein NMB (GPNMB) over-expressing triple negative breast cancer. The study is being conducted by a premier academic medical oncology group with extensive experience in writing and conducting clinical trials.
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“This is the most promising phase 3 trial in triple negative breast cancer in the last five years, since the phase 3 trial with the PARP inhibitor iniparib,” says Cleveland Clinic oncologist and principal investigator Alberto Montero, MD. “CDX-011 is a novel targeted drug for a disease that is defined clinically by the absence of any targets. A potent chemotherapy is delivered in a targeted fashion by being attached to an antibody that recognizes GPNMB, which is overexpressed in about 25 to 30 percent of all triple negative breast cancers.”
The primary objective of the study is to evaluate the anti-cancer activity of CDX-011, as measured by the objective response rate and duration of progression-free survival. Secondary objectives are to further assess the anti-cancer activity of CDX-011, as assessed by duration of response and overall survival; to further characterize the safety of CDX-011; and to obtain pharmacokinetic parameters and explore the relationships between patient-specific measures of exposure and safety and activity parameters. Researchers are also planning to explore whether treatment with CDX-011 is associated with improvement in quality of life and/or cancer-related pain, as reflected by reduced analgesic use.
Patients who are eligible for the study will be randomized (2:1) to receive CDX-011 or capecitabine, an orally-administered systemic prodrug of 5’-deoxy-5-fluorouridine, which is converted to 5-fluorouracil. Treatment and associated study visits will continue at three-week intervals until disease progression or intolerance. Tumor assessments will be performed at six-week intervals for six months and at nine-week intervals thereafter, until disease progression.
“The CDX-011study provides new hope for patients with triple negative breast cancer since it involves a trial with targeted delivery of chemotherapy with a monoclonal antibody and is testing the utility of GPNMB as a potential therapeutic target in triple negative breast cancer,” says Dr. Montero. “Just like the new drug T-DM1 is an antibody-drug combination that was recently approved for use in advanced HER2 positive breast cancer, this drug could be the first FDA-approved targeted treatment for triple negative breast cancer.”
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