Invasive carcinoma of breast
Item
patients must have histologically or cytologically confirmed invasive cancer of the breast
boolean
C0853879 (UMLS CUI [1])
Advanced disease Locally | Neoplasm Metastasis | Excision Curative intent Unsuccessful
Item
patients must have documented locally advanced/metastatic disease, defined by the investigator, which is not amenable to resection with curative intent.
boolean
C0679246 (UMLS CUI [1,1])
C1517927 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2])
C0728940 (UMLS CUI [3,1])
C1276305 (UMLS CUI [3,2])
C1272705 (UMLS CUI [3,3])
HER2-positive carcinoma of breast
Item
patients must have her2-positive breast cancer as defined by asco/cap 2013 guidelines that is confirmed by a sponsor-designated central laboratory
boolean
C1960398 (UMLS CUI [1])
Disease Progression | Intolerance to Pertuzumab
Item
patients must have progressed on, or be intolerant to pertuzumab in the labc/mbc setting
boolean
C0242656 (UMLS CUI [1])
C1744706 (UMLS CUI [2,1])
C1328025 (UMLS CUI [2,2])
Disease Progression | Intolerance to Ado-trastuzumab emtansine
Item
patients must have progressed on, or be intolerant to ado-trastuzumab emtansine in the labc/mbc setting
boolean
C0242656 (UMLS CUI [1])
C1744706 (UMLS CUI [2,1])
C2935436 (UMLS CUI [2,2])
Trastuzumab Previous | Pertuzumab Previous
Item
patients must have been previously treated with trastuzumab in any setting (which may have been previously administered with or without pertuzumab)
boolean
C0728747 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C1328025 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
ECOG performance status
Item
ecog performance status of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Doxorubicin | doxorubicin liposome | Epirubicin | Mitoxantrone | Anthracycline Derivative
Item
patients who have previously been treated with doxorubicin, liposomal doxorubicin, epirubicin, mitoxantrone, or any other anthracycline derivative
boolean
C0013089 (UMLS CUI [1])
C0717726 (UMLS CUI [2])
C0014582 (UMLS CUI [3])
C0026259 (UMLS CUI [4])
C0282564 (UMLS CUI [5,1])
C1527240 (UMLS CUI [5,2])
CNS metastases | Exception Treatment completed | Exception Stable status Without Symptoms | Exception Steroids Absent
Item
subjects with central nervous system (cns) metastases, unless they have been treated and are stable without symptoms for 4 weeks after completion of treatment and must be off steroids for at least 4 weeks prior to enrollment
boolean
C0686377 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0580352 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0205360 (UMLS CUI [3,2])
C0332288 (UMLS CUI [3,3])
C1457887 (UMLS CUI [3,4])
C1705847 (UMLS CUI [4,1])
C0038317 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
Congestive heart failure New York Heart Association Classification | Heart failure with preserved ejection fraction [HFpEF]
Item
patients with any class of new york heart association (nyha) chf or heart failure with preserved ejection fraction (hfpef)
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C4509226 (UMLS CUI [2])
Coronary Artery Disease | Myocardial Infarction
Item
patients with a history of known coronary artery disease or a myocardial infarction within the last 12 months
boolean
C1956346 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
Cardiac Arrhythmia Serious Treatment required for | Exception Controlled atrial fibrillation | Exception Paroxysmal supraventricular tachycardia
Item
patients with a known history of serious cardiac arrhythmias requiring treatment (exception: controlled atrial fibrillation, paroxysmal supraventricular tachycardia)
boolean
C0003811 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0332121 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0577699 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0030590 (UMLS CUI [3,2])
Trastuzumab Discontinued Due to Cardiotoxicity
Item
patients who previously discontinued trastuzumab due to unacceptable cardiac toxicity
boolean
C0728747 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0876994 (UMLS CUI [1,4])
Left ventricular ejection fraction | trastuzumab | lapatinib | HER2 Targeted Therapy
Item
patients with a history of lvef decline to below 50% during or after prior trastuzumab/lapatinib or other her2 directed therapy.
boolean
C0428772 (UMLS CUI [1])
C0728747 (UMLS CUI [2])
C1506770 (UMLS CUI [3])
C0069515 (UMLS CUI [4,1])
C2985566 (UMLS CUI [4,2])