Criteria Fulfill
Item
among other criteria, patients must meet all of the following conditions to be eligible for the study:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Age
Item
1. 18 years of age or older.
boolean
C0001779 (UMLS CUI [1])
Locally advanced breast cancer | Secondary malignant neoplasm of female breast
Item
2. locally advanced or metastatic breast cancer.
boolean
C3495949 (UMLS CUI [1])
C0346993 (UMLS CUI [2])
Prior Chemotherapy Quantity Breast Carcinoma Progressive | Prior Chemotherapy Quantity Breast cancer recurrent | Prior Chemotherapy Quantity Secondary malignant neoplasm of female breast
Item
3. previous treatment with at least two but no more than seven prior chemotherapy treatments for progressive, recurrent or metastatic breast cancer.
boolean
C1514457 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
C0205329 (UMLS CUI [1,4])
C1514457 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0278493 (UMLS CUI [2,3])
C1514457 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0346993 (UMLS CUI [3,3])
Exception Patient Inappropriate Pharmaceutical Preparations | Prior Therapy Including Pharmaceutical Preparations | taxane | Anthracycline | capecitabine | trastuzumab | lapatinib | Tumor HER2 Positive
Item
4. unless not a candidate for these agents, prior therapies must have included a taxane, an anthracycline, and capecitabine, as well as trastuzumab and lapatinib for patients whose tumors are positive for the human epidermal growth factor receptor 2 (her2). (patients who received incomplete courses of therapy with these agents due to intolerance will be eligible.)
boolean
C1705847 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,4])
C1514463 (UMLS CUI [2,1])
C0332257 (UMLS CUI [2,2])
C0013227 (UMLS CUI [2,3])
C0215136 (UMLS CUI [3])
C0282564 (UMLS CUI [4])
C0671970 (UMLS CUI [5])
C0728747 (UMLS CUI [6])
C1506770 (UMLS CUI [7])
C0027651 (UMLS CUI [8,1])
C2348909 (UMLS CUI [8,2])
Breast Carcinoma GPNMB Expression | Determined by Tissue specimen Analysis
Item
5. breast cancer tumor confirmed to express gpnmb. this will be determined by submitting a tissue sample (obtained during a diagnostic biopsy or surgery) to a central laboratory for analysis.
boolean
C0678222 (UMLS CUI [1,1])
C1415205 (UMLS CUI [1,2])
C0017262 (UMLS CUI [1,3])
C0521095 (UMLS CUI [2,1])
C1292533 (UMLS CUI [2,2])
C0002778 (UMLS CUI [2,3])
Criteria Fulfill
Item
among other criteria, patients who meet any of the following conditions are not eligible for the study:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Neuropathy CTCAE Grades | Toxicity CTCAE Grades | Relationship Chemotherapy | Relationship Therapeutic radiology procedure
Item
1. ongoing neuropathy or other chemotherapy or radiation-related toxicities that are moderate (grade 2) or worse in severity.
boolean
C0442874 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C0600688 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
C0439849 (UMLS CUI [3,1])
C0392920 (UMLS CUI [3,2])
C0439849 (UMLS CUI [4,1])
C1522449 (UMLS CUI [4,2])
Metastatic malignant neoplasm to brain | Exception Prior Therapy | Exception Disease Asymptomatic | Exception Progressive Disease Absent
Item
2. known brain metastases, unless previously treated and asymptomatic for 2 months and not progressive in size or number for 2 months.
boolean
C0220650 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1514463 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
C0231221 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1335499 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
Cardiovascular Disease | Medical condition Investigational Therapy At risk | CDX-011 | Chemotherapy | Medical condition Interferes with Interpretation Side effects
Item
3. significant cardiovascular disease or any other underlying medical condition that, in the investigator's opinion, will make the administration of study treatment (cdx-011 or chemotherapy) hazardous or would obscure the interpretation of side effects.
boolean
C0007222 (UMLS CUI [1])
C3843040 (UMLS CUI [2,1])
C0949266 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
C2935737 (UMLS CUI [3])
C0392920 (UMLS CUI [4])
C3843040 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C0459471 (UMLS CUI [5,3])
C0879626 (UMLS CUI [5,4])