Age
Item
female and male patients, >/= 18 years of age
boolean
C0001779 (UMLS CUI [1])
Breast adenocarcinoma Invasive Primary
Item
histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast
boolean
C0858252 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
Disease HER2 Positive
Item
her2-positive disease
boolean
C0012634 (UMLS CUI [1,1])
C2348909 (UMLS CUI [1,2])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status 0-1
boolean
C1520224 (UMLS CUI [1])
Hormone Therapy
Item
hormonal therapy will be allowed as per institutional guidelines
boolean
C0279025 (UMLS CUI [1])
Prior Therapy Against HER2 | Exception Neoadjuvant Therapy Early-Stage Breast Carcinoma
Item
prior use of anti-her2 therapy will be allowed except for early breast cancer patients in the neo-adjuvant setting
boolean
C1514463 (UMLS CUI [1,1])
C0521124 (UMLS CUI [1,2])
C0069515 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0600558 (UMLS CUI [2,2])
C2986665 (UMLS CUI [2,3])
Left ventricular ejection fraction
Item
left ventricular ejection fraction >/= 55%
boolean
C0428772 (UMLS CUI [1])
Residual disease Absent | Recurrent disease Locally Absent | Neoplasm Metastasis Absent | Status post Operative Surgical Procedures Completion | Status post Chemotherapy Completion | Chemotherapy Neoadjuvant | Chemotherapy, Adjuvant
Item
no evidence of residual, locally recurrent or metastatic disease after completion of surgery and chemotherapy, or during concurrent chemotherapy (neo-adjuvant or adjuvant)
boolean
C0543478 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0277556 (UMLS CUI [2,1])
C1517927 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0027627 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0231290 (UMLS CUI [4,1])
C0543467 (UMLS CUI [4,2])
C0205197 (UMLS CUI [4,3])
C0231290 (UMLS CUI [5,1])
C0392920 (UMLS CUI [5,2])
C0205197 (UMLS CUI [5,3])
C0392920 (UMLS CUI [6,1])
C0600558 (UMLS CUI [6,2])
C0085533 (UMLS CUI [7])
Therapeutic radiology procedure
Item
use of concurrent radiotherapy will be permitted
boolean
C1522449 (UMLS CUI [1])
Operative Surgical Procedures Completion Early-Stage Breast Carcinoma | Chemotherapy Completion Early-Stage Breast Carcinoma
Item
completion of surgery and chemotherapy (if applicable) for early breast cancer
boolean
C0543467 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C2986665 (UMLS CUI [1,3])
C0392920 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C2986665 (UMLS CUI [2,3])
Cancer Other | Exception Curative treatment Carcinoma in situ of uterine cervix | Exception Curative treatment Basal cell carcinoma | Exception Curative treatment Malignant Neoplasms | 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 who have been disease-free for the last 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])
C0006826 (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 | Severe dyspnea requiring oxygen supplement
Item
patients with severe dyspnea at rest or requiring supplementary oxygen therapy
boolean
C0743330 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2080706 (UMLS CUI [2])
Comorbidity Serious Interferes with Therapeutic procedure | Lung disease Severe
Item
patients with other concurrent serious diseases that might 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])
C0087111 (UMLS CUI [1,4])
C0024115 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Heart Disease Excludes Trastuzumab | Medical condition Excludes Trastuzumab | Congestive heart failure | High risk Cardiac Arrhythmia Uncontrolled | Angina Pectoris Requiring Pharmaceutical Preparations | Valvular disease | Transmural infarct ECG | Poor hypertension control
Item
serious cardiac illness or medical conditions that would preclude the use of trastuzumab, specifically: history of documented congestive heart failure, high-risk uncontrolled arrhythmias, angina pectoris requiring medication, clinically significant valvular disease, evidence of transmural infarction on ecg, poorly controlled hypertension
boolean
C0018799 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0728747 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0728747 (UMLS CUI [2,3])
C0018802 (UMLS CUI [3])
C4319571 (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])
C0333561 (UMLS CUI [7,1])
C0013798 (UMLS CUI [7,2])
C0421190 (UMLS CUI [8])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Unable | Childbearing Potential Contraceptive methods Unwilling | Gender Partner Childbearing Potential | Contraceptive methods Unable | Contraceptive methods Unwilling
Item
women of childbearing potential and male patients with female partners of childbearing potential who are unable or unwilling to use adequate contraceptive methods during study treatment
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
C0079399 (UMLS CUI [3,1])
C0682323 (UMLS CUI [3,2])
C3831118 (UMLS CUI [3,3])
C0700589 (UMLS CUI [4,1])
C1299582 (UMLS CUI [4,2])
C0700589 (UMLS CUI [5,1])
C0558080 (UMLS CUI [5,2])
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, biphosphonate 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 Pharmaceutical Excipient | Hyaluronidase allergy | Hypersensitivity Adhesives | Severe allergy | Immunologic reaction Severe | Asthma Control Difficult
Item
known hypersensitivity to trastuzumab, murine proteins, to any excipients of herceptin including hyaluronidase, or the adhesive of the sc device, or a history of severe allergic or immunological reactions, e.g. difficult 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])
C2945656 (UMLS CUI [6])
C0301873 (UMLS CUI [7,1])
C0205082 (UMLS CUI [7,2])
C0004096 (UMLS CUI [8,1])
C0243148 (UMLS CUI [8,2])
C0332218 (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])