Adult | Age
Item
adult patients >/=18 years of age
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
HER2-positive carcinoma of breast
Item
her2-positive breast cancer
boolean
C1960398 (UMLS CUI [1])
Breast adenocarcinoma recurrent Locally | Breast adenocarcinoma metastatic | Patients Appropriate Chemotherapy | Recurrent disease Advanced Locally | Progressive Disease Advanced Locally | Excision Curative intent Unsuccessful
Item
histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease, and be a candidate for chemotherapy. patients with locally advanced disease must have recurrent or progressive disease, which must not be amenable to resection with curative intent.
boolean
C0861355 (UMLS CUI [1,1])
C1517927 (UMLS CUI [1,2])
C1697918 (UMLS CUI [2])
C0030705 (UMLS CUI [3,1])
C1548787 (UMLS CUI [3,2])
C0392920 (UMLS CUI [3,3])
C0277556 (UMLS CUI [4,1])
C0205179 (UMLS CUI [4,2])
C1517927 (UMLS CUI [4,3])
C1335499 (UMLS CUI [5,1])
C0205179 (UMLS CUI [5,2])
C1517927 (UMLS CUI [5,3])
C0728940 (UMLS CUI [6,1])
C1276305 (UMLS CUI [6,2])
C1272705 (UMLS CUI [6,3])
Measurable Disease | Non-Measurable Lesion | Evaluable Disease
Item
patients must have measurable and/or non-measurable disease which must be evaluable per recist 1.1
boolean
C1513041 (UMLS CUI [1])
C1334988 (UMLS CUI [2])
C1516986 (UMLS CUI [3])
ECOG performance status
Item
ecog performance status 0 or 1
boolean
C1520224 (UMLS CUI [1])
Organ function Laboratory Results
Item
adequate organ function as determined by laboratory results
boolean
C0678852 (UMLS CUI [1,1])
C1254595 (UMLS CUI [1,2])
Prior Chemotherapy Secondary malignant neoplasm of female breast | Chemotherapy Secondary malignant neoplasm of female breast | Prior Chemotherapy Recurrent disease Advanced Locally | Chemotherapy Recurrent disease Advanced Locally
Item
history of prior (or any) chemotherapy for metastatic breast cancer or recurrent locally advanced disease
boolean
C1514457 (UMLS CUI [1,1])
C0346993 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C0346993 (UMLS CUI [2,2])
C1514457 (UMLS CUI [3,1])
C0277556 (UMLS CUI [3,2])
C0205179 (UMLS CUI [3,3])
C1517927 (UMLS CUI [3,4])
C0392920 (UMLS CUI [4,1])
C0277556 (UMLS CUI [4,2])
C0205179 (UMLS CUI [4,3])
C1517927 (UMLS CUI [4,4])
Vinca Alkaloid Cytotoxic Chemotherapy | Taxane Cytotoxic Chemotherapy
Item
an interval of <6 months from the last dose of vinca-alkaloid or taxane cytotoxic chemotherapy until the time of metastatic diagnosis
boolean
C0042672 (UMLS CUI [1,1])
C0677881 (UMLS CUI [1,2])
C0215136 (UMLS CUI [2,1])
C0677881 (UMLS CUI [2,2])
Hormone Therapy
Item
hormone therapy <7 days prior to randomization
boolean
C0279025 (UMLS CUI [1])
Trastuzumab Neoadjuvant Therapy | Lapatinib Neoadjuvant Therapy | Trastuzumab Adjuvant therapy | Lapatinib Adjuvant therapy
Item
trastuzumab therapy and/or lapatinib (neo- or adjuvant setting) <21 days prior to randomization
boolean
C0728747 (UMLS CUI [1,1])
C0600558 (UMLS CUI [1,2])
C1506770 (UMLS CUI [2,1])
C0600558 (UMLS CUI [2,2])
C0728747 (UMLS CUI [3,1])
C0677850 (UMLS CUI [3,2])
C1506770 (UMLS CUI [4,1])
C0677850 (UMLS CUI [4,2])
trastuzumab emtansine | pertuzumab
Item
prior trastuzumab emtansine or pertuzumab therapy
boolean
C2935436 (UMLS CUI [1])
C1328025 (UMLS CUI [2])