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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
327
Progression Free Survival (PFS)
PFS is defined as the time from randomization to the earlier of disease progression or death due to any cause. Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or progression in a non-target lesion, or the appearance of new lesions. The primary analysis of PFS was based on PFS events determined retrospectively by the central independent review committee, blinded to treatment assignment and investigator assessments according to RECIST 1.1 criteria.
Time frame: Evaluated every 6 - 9 weeks following treatment initiation
Objective Response Rate (ORR)
ORR is defined as the percentage of patients who achieve best overall response of complete or partial response. The analysis of ORR was based on ORR events determined retrospectively by the central independent review committee, blinded to treatment assignment and investigator assessments according to RECIST 1.1 criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), Complete Response (CR) = Disappearance of all target lesions and non-target lesions, Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions with no progression in non-target lesions and no new lesions.
Time frame: Evaluated every 6 - 9 weeks following treatment initiation
Duration of Response
Duration of response (DOR) is the number of months from the time criteria are first met for either CR or PR, until the first date that PD is objectively documented. The analysis of DOR was determined retrospectively by the central independent review committee,blinded to treatment assignment and investigator assessments according to RECIST 1.1 criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), Complete Response (CR) = Disappearance of all target lesions and non-target lesions, Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions with no progression in non-target lesions and no new lesions.
Time frame: Evaluated every 6 - 9 weeks following treatment initiation
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Alabama Oncology
Birmingham, Alabama, United States
University of Alabama at Birmingham
Birmingham, Alabama, United States
University of South Alabama Cancer Research Insititute
Mobile, Alabama, United States
Arizona Cancer Research Alliance
Glendale, Arizona, United States
Arizona Cancer Center
Tucson, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Compassionate Care Research Group
Fountain Valley, California, United States
St. Jude Heritage Medical Group
Fullerton, California, United States
USC Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States
University of California Davis Medical Center
Sacramento, California, United States
...and 130 more locations
Overall Survival
Overall Survival (OS) is defined as the number of months from randomization to the date of death due to any cause.
Time frame: During treatment and 3 months from end of treatment through end of study or approximately up to 5 years.
Adverse Events (AE)
The percentage of patients experiencing one or more adverse events will be summarized by treatment arm, relationship to study drug, and severity.
Time frame: Usually following at least 1 cycle of study treatment (1 dose of CDX-011 or capecitabine and until discontinuation of follow-up)
Pharmacokinetics (PK)
Concentration of the antibody drug conjugate (ADC), total antibody (TA) and free MMAE will be determined.
Time frame: Following 1 dose of CDX-011.