Study of Glembatumumab Vedotin (CDX-011) in Patients With Metastatic, gpNMB Over-Expressing, Triple Negative Breast Cancer
Condition: Metastatic gpNMB Over-expressing Triple Negative Breast Cancer
MeSH terms: Breast Neoplasms; Triple Negative Breast Neoplasms
Intervention: CDX-011; Capecitabine
Intervention MeSH terms: Capecitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 327.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Metastatic Breast Cancer; Locally advanced breast cancer; Breast cancer; Triple negative; Estrogen; Progesterone; HER2 receptors; Targeted treatment for breast cancer; Antibody-drug-conjugate; Breast Neoplasms; CDX-011; gpNMB; METRIC; Glembatumumab vedotin; Triple Negative Breast Cancer; TNBC

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

        Among other criteria, patients must meet all of the following conditions to be eligible for
        the study:

          1. Diagnosed with metastatic (i.e., cancer that has spread) TNBC

               -  minimal or no expression of estrogen and progesterone receptors (ER/PR) <10% of
                  cells positive by immunohistochemistry

               -  HER 2 staining 0 or 1+ by IHC or copy number <4.0 signals/cell

          2. Documented progression of disease based on radiographic, clinical or pathologic
             assessment during or subsequent to the last anticancer regimen received.

          3. Breast cancer tumor confirmed to express gpNMB. This will be determined by submitting
             a tissue sample from the advanced (locally advanced/recurrent or metastatic) disease
             setting to a central laboratory for analysis.

          4. Received no more than two prior chemotherapy treatments for advanced (locally
             advanced/recurrent or metastatic) breast cancer.

          5. Prior chemotherapy treatment must have contained an anthracycline (e.g. doxorubicin or
             Doxil) if clinically indicated and a taxane (eg: Taxol).

          6. ECOG performance status of 0 - 1.

          7. Adequate bone marrow, liver and renal function.

        Exclusion:

        Among other criteria, patients who meet any of the following conditions are NOT eligible
        for the study:

          1. Progression/recurrence of breast cancer during or within 3 months of completion of
             neoadjuvant or adjuvant chemotherapy.

          2. Ongoing neuropathy or other chemotherapy or radiation-related toxicities that are
             moderate (Grade 2) or worse in severity.

          3. Known brain metastases, unless previously treated and asymptomatic for 2 months and
             not progressive in size or number for 2 months.

          4. Significant cardiovascular disease.

          5. Previously received capecitabine and discontinued due to progression or intolerance;
             previously received CDX-011 or other MMAE containing agents.

          6. Active systemic infection requiring treatment. Infection controlled by oral therapy
             will not be exclusionary.

          7. Chronic use of systemic corticosteroids.