Age
Item
female and male patients, >/= 18 years of age
boolean
C0001779 (UMLS CUI [1])
Breast adenocarcinoma Invasive | Neoplasm Metastasis Absent
Item
histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast
boolean
C0858252 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Disease HER2 Positive Immunohistochemistry | Disease HER2 Positive In Situ Hybridization Staining Method
Item
her2-positive disease immunohistochemistry (ihc) 3+ or in situ hybridization (ish) positive
boolean
C0012634 (UMLS CUI [1,1])
C2348909 (UMLS CUI [1,2])
C0021044 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C2348909 (UMLS CUI [2,2])
C3853647 (UMLS CUI [2,3])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status 0-1
boolean
C1520224 (UMLS CUI [1])
Left ventricular ejection fraction | Status pre- Trastuzumab Subcutaneous
Item
left ventricular ejection fraction (lvef) of >/= 55% prior to first dose of trastuzumab sc
boolean
C0428772 (UMLS CUI [1])
C0332152 (UMLS CUI [2,1])
C0728747 (UMLS CUI [2,2])
C1522438 (UMLS CUI [2,3])
Intact skin | Thigh Site Subcutaneous Injection
Item
intact skin at site of sc injection on the thigh
boolean
C2712179 (UMLS CUI [1])
C0039866 (UMLS CUI [2,1])
C1515974 (UMLS CUI [2,2])
C0021499 (UMLS CUI [2,3])
Cancer Other | Exception Curative treatment Carcinoma in situ of uterine cervix | Exception Curative treatment Basal cell carcinoma | Exception Curative treatment Cancer Other | Exception Disease Free Duration
Item
history of other malignancy, except for patients with curatively treated carcinoma in situ of the cervix or basal cell carcinoma and patients with other curatively treated malignancies, other than breast cancer, who have been disease-free for at least 5 years
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1273390 (UMLS CUI [2,2])
C0851140 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0007117 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1273390 (UMLS CUI [4,2])
C1707251 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0012634 (UMLS CUI [5,2])
C0332296 (UMLS CUI [5,3])
C0449238 (UMLS CUI [5,4])
Resting Dyspnea Severe | Requirement Oxygen supplementation
Item
severe dyspnea at rest or requiring supplementary oxygen therapy
boolean
C0743330 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C0919655 (UMLS CUI [2,2])
Comorbidity Serious Interferes with Planned Treatment | Lung diseases Severe
Item
concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C3641097 (UMLS CUI [1,4])
C0024115 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Heart Disease Serious | Medical condition Excludes Trastuzumab | Congestive heart failure | High risk of Cardiac Arrhythmia Uncontrolled | Angina Pectoris Requirement Pharmaceutical Preparations | Valvular disease | Transmural myocardial infarction Electrocardiography | Poor hypertension control
Item
serious cardiac illness or medical conditions that would preclude the use of trastuzumab, specifically: history of documented congestive heart failure (chf), high-risk uncontrolled arrhythmias, angina pectoris requiring medication, clinically significant valvular disease, evidence of transmural infarction on electrocardiogram (ecg), diagnosed poorly controlled hypertension
boolean
C0018799 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C3843040 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0728747 (UMLS CUI [2,3])
C0018802 (UMLS CUI [3])
C0332167 (UMLS CUI [4,1])
C0003811 (UMLS CUI [4,2])
C0205318 (UMLS CUI [4,3])
C0002962 (UMLS CUI [5,1])
C1514873 (UMLS CUI [5,2])
C0013227 (UMLS CUI [5,3])
C3258293 (UMLS CUI [6])
C1400513 (UMLS CUI [7,1])
C1623258 (UMLS CUI [7,2])
C0421190 (UMLS CUI [8])
HIV Infection | Hepatitis B | Hepatitis C
Item
known infection with human immunodeficiency virus (hiv), active hepatitis b virus (hbv) or hepatitis c virus (hcv)
boolean
C0019693 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Study Subject Participation Status | Cancer treatment Investigational | Hormone Therapy | Diphosphonates | Immunotherapy
Item
concurrent enrolment in another clinical trial using an investigational anti-cancer treatment, including hormonal therapy, bisphosphonate therapy and immunotherapy, within 28 days prior to the first dose of study treatment
boolean
C2348568 (UMLS CUI [1])
C0920425 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
C0279025 (UMLS CUI [3])
C0012544 (UMLS CUI [4])
C0021083 (UMLS CUI [5])
Hypersensitivity Trastuzumab | Hypersensitivity Murine protein | Hypersensitivity Herceptin Excipient | Hyaluronidase allergy | Hypersensitivity Adhesive Device | Severe allergic reaction | Immunologic reaction Severe | Difficulty with Asthma Control
Item
known hypersensitivity to trastuzumab, murine proteins, to any of the excipients of herceptin including hyaluronidase, or the adhesive of the sc device (for cohort b), or a history of severe allergic or immunological reactions, e.g. difficulty to control asthma
boolean
C0020517 (UMLS CUI [1,1])
C0728747 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1699668 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0338204 (UMLS CUI [3,2])
C0015237 (UMLS CUI [3,3])
C0572015 (UMLS CUI [4])
C0020517 (UMLS CUI [5,1])
C0001516 (UMLS CUI [5,2])
C0025080 (UMLS CUI [5,3])
C2220378 (UMLS CUI [6])
C0301873 (UMLS CUI [7,1])
C0205082 (UMLS CUI [7,2])
C0332218 (UMLS CUI [8,1])
C0004096 (UMLS CUI [8,2])
C2587213 (UMLS CUI [8,3])
Bone Marrow function Inadequate | Liver function Inadequate | Renal function Inadequate
Item
inadequate bone marrow, hepatic or renal function
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0205412 (UMLS CUI [1,3])
C0232741 (UMLS CUI [2,1])
C0205412 (UMLS CUI [2,2])
C0232804 (UMLS CUI [3,1])
C0205412 (UMLS CUI [3,2])
Motor neuropathy Pre-existing CTCAE Grades | Sensory neuropathy Pre-existing CTCAE Grades
Item
pre-existing motor or sensory neuropathy of grade > 1
boolean
C0235025 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
C0151313 (UMLS CUI [2,1])
C2347662 (UMLS CUI [2,2])
C1516728 (UMLS CUI [2,3])