Solid tumour incurable | Treatment option | Neratinib | Capecitabine
Item
part 1: confirmed pathologic diagnosis of a solid tumor not curable with available therapies for which neratinib plus capecitabine is a reasonable treatment option.
boolean
C0280100 (UMLS CUI [1,1])
C0175969 (UMLS CUI [1,2])
C0683525 (UMLS CUI [2])
C2713008 (UMLS CUI [3])
C0671970 (UMLS CUI [4])
Secondary malignant neoplasm of female breast | Locally advanced breast cancer
Item
part 2: confirmed histologically and/or cytologically confirmed diagnosis of breast cancer, metastatic or locally advanced.
boolean
C0346993 (UMLS CUI [1])
C3495949 (UMLS CUI [2])
HER2 gene amplification Neoplasm FISH | HER2 gene amplification Neoplasm CISH | ERBB2 Protein Overexpression Immunohistochemistry Positive
Item
part 2: erbb-2 gene amplified tumor (fish or cish) or erbb-2 overexpression (ihc 3+, or ihc2+ with fish or cish confirmation), based on local testing, or based on centralized fish testing prior to day 1.
boolean
C1512127 (UMLS CUI [1,1])
C0027651 (UMLS CUI [1,2])
C0162789 (UMLS CUI [1,3])
C1512127 (UMLS CUI [2,1])
C0027651 (UMLS CUI [2,2])
C1516514 (UMLS CUI [2,3])
C1515560 (UMLS CUI [3,1])
C0021044 (UMLS CUI [3,2])
C1514241 (UMLS CUI [3,3])
Disease Progression | trastuzumab | Therapeutic procedure Quantity Secondary malignant neoplasm of female breast | Therapeutic procedure Quantity Locally advanced breast cancer
Item
part 2: disease progression on or following at least 1 prior trastuzumab containing treatment regimen (at least 6 weeks) for metastatic or locally advanced disease. (prior adjuvant trastuzumab is allowed but not required). a 2 week period is required between the last dose of trastuzumab treatment and first dose of the test article.
boolean
C0242656 (UMLS CUI [1])
C0728747 (UMLS CUI [2])
C0087111 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0346993 (UMLS CUI [3,3])
C0087111 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C3495949 (UMLS CUI [4,3])
Taxane | Neoadjuvant Therapy | Adjuvant therapy | Locally advanced breast cancer | Secondary malignant neoplasm of female breast
Item
prior treatment with a taxane in the neoadjuvant, adjuvant, locally advanced, and/or metastatic disease treatment setting.
boolean
C0215136 (UMLS CUI [1])
C0600558 (UMLS CUI [2])
C0677850 (UMLS CUI [3])
C3495949 (UMLS CUI [4])
C0346993 (UMLS CUI [5])
Measurable lesion Quantity
Item
parts 1+2: at least 1 measurable lesion as defined by recist criteria.
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Left ventricular ejection fraction MUGA | Left ventricular ejection fraction Echocardiography
Item
parts 1+2: lvef within institutional range of normal as measured by multi-gated acquisition (muga) or echocardiogram (echo).
boolean
C0428772 (UMLS CUI [1,1])
C0521317 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2,1])
C0013516 (UMLS CUI [2,2])
capecitabine | lapatinib | Pharmaceutical Preparations Targeting ERBB2 | Exception Trastuzumab
Item
part 2: prior treatment with capecitabine, lapatinib (20 subjects with prior lapatinib exposure will be enrolled) or any erbb-2 targeted agents except trastuzumab. treatment with erbb-2 targeted therapy must exceed 2 weeks (14 days) in order to be exclusionary.
boolean
C0671970 (UMLS CUI [1])
C1506770 (UMLS CUI [2])
C0013227 (UMLS CUI [3,1])
C1521840 (UMLS CUI [3,2])
C0242957 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0728747 (UMLS CUI [4,2])
Anthracyclines | Doxorubicin Cumulative Dose | Epirubicin Dose | Anthracyclines Dose Equivalent
Item
part 2: prior treatment with anthracyclines with a cumulative dose of doxorubicin of greater than 400 mg/m2, epirubicin dose of greater than 800 mg/m2, or the equivalent dose for other anthracyclines.
boolean
C0282564 (UMLS CUI [1])
C0013089 (UMLS CUI [2,1])
C2986497 (UMLS CUI [2,2])
C0014582 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0282564 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0205163 (UMLS CUI [4,3])
Disease Bone Site only
Item
parts 1+2: subjects with bone as the only site of disease.
boolean
C0012634 (UMLS CUI [1,1])
C0262950 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
C0205171 (UMLS CUI [1,4])
CNS metastases Uncontrolled | CNS metastases Symptomatic | Symptoms Clinical | Cerebral Edema | CNS metastases Growth Progressive | Definitive Treatment CNS metastases allowed | Definitive Treatment Compression of spinal cord allowed | Anticonvulsants Discontinued | Steroids Discontinued
Item
parts 1+2: active uncontrolled or symptomatic central nervous system (cns) metastases, as indicated by clinical symptoms, cerebral edema, and/or progressive growth. subjects with a history of cns metastases or cord compression are allowable if they have been considered definitively treated and are off anticonvulsants and steroids for at least 4 weeks before the first dose of test article.
boolean
C0686377 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0686377 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C1457887 (UMLS CUI [3,1])
C0205210 (UMLS CUI [3,2])
C0006114 (UMLS CUI [4])
C0686377 (UMLS CUI [5,1])
C2911660 (UMLS CUI [5,2])
C0205329 (UMLS CUI [5,3])
C2986592 (UMLS CUI [6,1])
C0686377 (UMLS CUI [6,2])
C0683607 (UMLS CUI [6,3])
C2986592 (UMLS CUI [7,1])
C0037926 (UMLS CUI [7,2])
C0683607 (UMLS CUI [7,3])
C0003286 (UMLS CUI [8,1])
C1444662 (UMLS CUI [8,2])
C0038317 (UMLS CUI [9,1])
C1444662 (UMLS CUI [9,2])
Cancer Other | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated
Item
parts 1+2: any other cancer within 5 years prior to screening with the exception of adequately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])