HER2-positive carcinoma of breast Immunohistochemistry | HER2-positive carcinoma of breast Fluorescent in Situ Hybridization
Item
1. her-2 positive breast cancer by immunohistochemistry and/or fluorescence in-situ hybridisation.
boolean
C1960398 (UMLS CUI [1,1])
C0021044 (UMLS CUI [1,2])
C1960398 (UMLS CUI [2,1])
C0162789 (UMLS CUI [2,2])
Neoadjuvant Chemotherapy Planned | Adjuvant Chemotherapy Planned | trastuzumab | Combined Modality Therapy
Item
2. planned neoadjuvant and/or adjuvant treatment with chemotherapy and trastuzumab either sequentially or in combination or single agent trastuzumab.
boolean
C0392920 (UMLS CUI [1,1])
C0600558 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C0085533 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C0728747 (UMLS CUI [3])
C0009429 (UMLS CUI [4])
Age
Item
3. 18 years of age or older.
boolean
C0001779 (UMLS CUI [1])
Disease TNM Breast tumor staging | trastuzumab | Combined Modality Therapy
Item
4. disease stage i-iii, whose treatment plan includes trastuzumab either sequentially, in combination or as a single agent will be eligible for inclusion in the study.
boolean
C0012634 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
C0728747 (UMLS CUI [2])
C0009429 (UMLS CUI [3])
Study Subject Participation Status | Therapeutic Clinical Trial
Item
5. as this is a non-interventional study, patients enrolled in therapeutic clinical trials will also be eligible for inclusion.
boolean
C2348568 (UMLS CUI [1])
C1515364 (UMLS CUI [2])
Curative procedure
Item
6. treatment with curative intent.
boolean
C1276305 (UMLS CUI [1])
ECOG performance status
Item
7. ecog performance status 0, 1 or 2.
boolean
C1520224 (UMLS CUI [1])
Cardiac function MUGA | Cardiac function Echocardiography
Item
8. adequate cardiac function, with muga or echocardiograph > 50%.
boolean
C0232164 (UMLS CUI [1,1])
C0521317 (UMLS CUI [1,2])
C0232164 (UMLS CUI [2,1])
C0013516 (UMLS CUI [2,2])
Informed Consent
Item
9. written informed consent.
boolean
C0021430 (UMLS CUI [1])
Medical condition Study Subject Participation Status At risk Patient | Mental condition Study Subject Participation Status At risk Patient
Item
1. presence of a medical or psychiatric condition, which, in the opinion of the investigator, would potentially pose a risk to the patient by participating in this trial.
boolean
C3843040 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C0030705 (UMLS CUI [1,4])
C3840291 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
C0030705 (UMLS CUI [2,4])
Neoplasm Metastasis
Item
2. evidence of metastatic disease.
boolean
C0027627 (UMLS CUI [1])
Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure | Valvular disease | Aortic regurgitation Grade | Mitral regurgitation Grade | Aortic Valve Stenosis | Mitral Valve Stenosis | Cardiac Arrhythmia Uncontrolled | Myocardial Infarction Symptomatic | Myocardial Infarction Asymptomatic | Angina Pectoris Requirement Antianginals
Item
3. patients with uncontrolled hypertension (sustained systolic blood pressure >180mmhg or diastolic blood pressure >100mmhg), significant valvular disease (aortic or mitral regurgitation of 3 or 4+/ 4+ severity or stenosis of either valve), history of uncontrolled cardiac arrhythmias, prior symptomatic or asymptomatic myocardial infarction or angina pectoris requiring anti-anginal medication.
boolean
C1868885 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
C3258293 (UMLS CUI [4])
C0003504 (UMLS CUI [5,1])
C0441800 (UMLS CUI [5,2])
C0026266 (UMLS CUI [6,1])
C0441800 (UMLS CUI [6,2])
C0003507 (UMLS CUI [7])
C0026269 (UMLS CUI [8])
C0003811 (UMLS CUI [9,1])
C0205318 (UMLS CUI [9,2])
C0027051 (UMLS CUI [10,1])
C0231220 (UMLS CUI [10,2])
C0027051 (UMLS CUI [11,1])
C0231221 (UMLS CUI [11,2])
C0002962 (UMLS CUI [12,1])
C1514873 (UMLS CUI [12,2])
C3537168 (UMLS CUI [12,3])
Anthracyclines | trastuzumab
Item
4. prior anthracycline or trastuzumab therapy.
boolean
C0282564 (UMLS CUI [1])
C0728747 (UMLS CUI [2])
Informed Consent Unable
Item
5. inability to give informed consent for any reason.
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])