Breast Carcinoma HER2 Protein Overexpression
Item
histologically confirmed diagnosis of her2-overexpression breast cancer
boolean
C0678222 (UMLS CUI [1,1])
C1515560 (UMLS CUI [1,2])
Neoplasm Metastasis
Item
stage iv metastatic disease
boolean
C0027627 (UMLS CUI [1])
Prior Therapy | trastuzumab | Disease Progression
Item
must have progressed on one prior trastuzumab treatment
boolean
C1514463 (UMLS CUI [1])
C0728747 (UMLS CUI [2])
C0242656 (UMLS CUI [3])
trastuzumab | Prior Therapy Adjuvant | First line treatment Previous
Item
no more than one prior trastuzumab based therapy regimen (either adjuvant or first-line)
boolean
C0728747 (UMLS CUI [1])
C1514463 (UMLS CUI [2,1])
C1522673 (UMLS CUI [2,2])
C1708063 (UMLS CUI [3,1])
C0205156 (UMLS CUI [3,2])
Adjuvant Chemotherapy Breast Carcinoma | Anthracyclines | taxane | First line treatment Secondary malignant neoplasm of female breast
Item
must have received anthracycline and/or taxane based chemotherapy for adjuvant treatment of breast cancer or first-line treatment of metastatic breast cancer
boolean
C0085533 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0282564 (UMLS CUI [2])
C0215136 (UMLS CUI [3])
C1708063 (UMLS CUI [4,1])
C0346993 (UMLS CUI [4,2])
Availability of Tumor tissue sample | Assessment Repeated HER2 Status
Item
must have (archived) tumour tissue sample available for central re-assessment of her2-status
boolean
C0470187 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
C1516048 (UMLS CUI [2,1])
C0205341 (UMLS CUI [2,2])
C1512413 (UMLS CUI [2,3])
Measurable lesion Quantity
Item
at least one measurable lesion according to recist 1.1.
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
ECOG performance status
Item
ecog score of 0 or 1 .
boolean
C1520224 (UMLS CUI [1])
Prior Therapy | Small Molecules HER2 Targeted | Antibodies HER2 Targeted | Exception Trastuzumab
Item
prior treatment with egfr/her2-targeted small molecules or antibodies other than trastuzumab
boolean
C1514463 (UMLS CUI [1])
C1328819 (UMLS CUI [2,1])
C0069515 (UMLS CUI [2,2])
C1521840 (UMLS CUI [2,3])
C0003241 (UMLS CUI [3,1])
C0069515 (UMLS CUI [3,2])
C1521840 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0728747 (UMLS CUI [4,2])
Prior Therapy | vinorelbine
Item
prior treatment with vinorelbine
boolean
C1514463 (UMLS CUI [1])
C0078257 (UMLS CUI [2])
Interstitial Lung Disease Pre-existing
Item
known pre-existing interstitial lung disease
boolean
C0206062 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
Metastatic malignant neoplasm to brain
Item
active brain metastases
boolean
C0220650 (UMLS CUI [1])
Cardiovascular Abnormalities | Uncontrolled hypertension | Congestive heart failure New York Heart Association Classification | Angina, Unstable | Cardiac Arrhythmia Poorly controlled | Myocardial Infarction
Item
history or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure nyha classification of 3, unstable angina or poorly controlled arrhythmia. myocardial infarction within 6 months prior to randomisation.
boolean
C0243050 (UMLS CUI [1])
C1868885 (UMLS CUI [2])
C0018802 (UMLS CUI [3,1])
C1275491 (UMLS CUI [3,2])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5,1])
C3853134 (UMLS CUI [5,2])
C0027051 (UMLS CUI [6])
Left Ventricular Function | EJECTION FRACTION RESTING
Item
cardiac left ventricular function with resting ejection fraction of less than 50%.
boolean
C0080310 (UMLS CUI [1])
C0743403 (UMLS CUI [2])
Protocol Compliance Unable
Item
patients unable to comply with the protocol.
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Medical contraindication Vinorelbine | Medical contraindication Trastuzumab
Item
any contraindications for therapy with vinorelbine or trastuzumab.
boolean
C1301624 (UMLS CUI [1,1])
C0078257 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0728747 (UMLS CUI [2,2])
Hypersensitivity BIBW 2992 | Hypersensitivity Investigational New Drug Excipient
Item
known hypersensitivity to bibw 2992 or the excipients of any of the trial drugs.
boolean
C0020517 (UMLS CUI [1,1])
C4083270 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
Use of Investigational New Drugs Recently
Item
use of any investigational drug within 4 weeks of randomisation.
boolean
C1524063 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
Liver function Inadequate | Renal function Inadequate | Hematologic function Inadequate
Item
inadequate hepatic, renal and haematologic organ function
boolean
C0232741 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
C0232804 (UMLS CUI [2,1])
C0205412 (UMLS CUI [2,2])
C0221130 (UMLS CUI [3,1])
C0205412 (UMLS CUI [3,2])