ECOG performance status
Item
1. performance status ecog 0-1
boolean
C1520224 (UMLS CUI [1])
Invasive carcinoma of breast
Item
2. histologically confirmed invasive breast cancer,
boolean
C0853879 (UMLS CUI [1])
Primary tumor Diameter | Primary tumor Clinical examination | Primary tumor Mammography | Primary tumor Ultrasonography | Primary tumor MRI | Patient Appropriate Neoadjuvant Chemotherapy
Item
3. primary tumour greater ≥ 2 cm diameter, measured by clinical examination and mammography or echography or rmn candidate to neoadjuvant chemotherapy ,
boolean
C0677930 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C0677930 (UMLS CUI [2,1])
C1456356 (UMLS CUI [2,2])
C0677930 (UMLS CUI [3,1])
C0024671 (UMLS CUI [3,2])
C0677930 (UMLS CUI [4,1])
C0041618 (UMLS CUI [4,2])
C0677930 (UMLS CUI [5,1])
C0024485 (UMLS CUI [5,2])
C0030705 (UMLS CUI [6,1])
C1548787 (UMLS CUI [6,2])
C0600558 (UMLS CUI [6,3])
C3665472 (UMLS CUI [6,4])
Lymph nodal status Any
Item
4. any n,
boolean
C0449927 (UMLS CUI [1,1])
C1552551 (UMLS CUI [1,2])
Neoplasm Metastasis Absent
Item
5. no evidence of metastasis (m0);
boolean
C0027627 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
HER2 Overexpression Component Invasive | HER2 gene amplification Component Invasive | Component Invasive Primary tumor
Item
6. over expression and/or amplification of her2 in the invasive component of the primary tumour according to one of the following definitions:
boolean
C1515560 (UMLS CUI [1,1])
C1705248 (UMLS CUI [1,2])
C0205281 (UMLS CUI [1,3])
C1512127 (UMLS CUI [2,1])
C1705248 (UMLS CUI [2,2])
C0205281 (UMLS CUI [2,3])
C1705248 (UMLS CUI [3,1])
C0205281 (UMLS CUI [3,2])
C0677930 (UMLS CUI [3,3])
Overexpression Immunohistochemistry | Tumor Cell Invasive Percentage
Item
7. 3+ over expression by ihc (> 30% of invasive tumour cells),
boolean
C1514559 (UMLS CUI [1,1])
C0021044 (UMLS CUI [1,2])
C0597032 (UMLS CUI [2,1])
C0205281 (UMLS CUI [2,2])
C0439165 (UMLS CUI [2,3])
Overexpression Immunohistochemistry | Tumor Cell Percentage | HER2 gene amplification FISH | HER2 gene amplification CISH
Item
8. 2+ or 3+ (in 30% o less neoplastic cells) overexpression by ihc and in situ hybridization (fish/cish) test demonstrating her2 gene amplication ,
boolean
C1514559 (UMLS CUI [1,1])
C0021044 (UMLS CUI [1,2])
C0597032 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C1512127 (UMLS CUI [3,1])
C0162789 (UMLS CUI [3,2])
C1512127 (UMLS CUI [4,1])
C1516514 (UMLS CUI [4,2])
HER2 gene amplification FISH | HER2 gene amplification CISH | Ratio measurement
Item
9. her 2 gene amplication by fish/cish (ratio > 2.2);
boolean
C1512127 (UMLS CUI [1,1])
C0162789 (UMLS CUI [1,2])
C1512127 (UMLS CUI [2,1])
C1516514 (UMLS CUI [2,2])
C1261161 (UMLS CUI [3])
Hormone Receptor Status Known
Item
10. known hormone receptor status
boolean
C0019929 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C0205309 (UMLS CUI [1,3])
Status Hematopoietic
Item
11. hematopoietic status:
boolean
C0449438 (UMLS CUI [1,1])
C0229601 (UMLS CUI [1,2])
Absolute neutrophil count
Item
1. absolute neutrophil count ≥ 1.5 x 109/l,
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
2. platelet count ≥ 100 x 109/l,
boolean
C0032181 (UMLS CUI [1])
Status Hepatic
Item
12. hepatic status:
boolean
C0449438 (UMLS CUI [1,1])
C0205054 (UMLS CUI [1,2])
Serum total bilirubin measurement | Gilbert Disease
Item
1. serum total bilirubin ≤ 1.5 x uln. in the case of known gilbert's syndrome a higher serum total bilirubin (< 2 x uln) is allowed,
boolean
C1278039 (UMLS CUI [1])
C0017551 (UMLS CUI [2])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
2. ast and alt ≤ 2.5 times uln,
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Alkaline phosphatase measurement
Item
3. alkaline phosphatase ≤ 2.5 times uln;
boolean
C0201850 (UMLS CUI [1])
Status renal
Item
13. renal status:
boolean
C0449438 (UMLS CUI [1,1])
C0022646 (UMLS CUI [1,2])
Creatinine measurement, serum
Item
a. creatinine ≤ 2.0 mg/dl;
boolean
C0201976 (UMLS CUI [1])
Status Cardiovascular
Item
14. cardiovascular:
boolean
C0449438 (UMLS CUI [1,1])
C3887460 (UMLS CUI [1,2])
Left ventricular ejection fraction Echocardiography | Left ventricular ejection fraction MUGA scan
Item
a. baseline lvef ≥ 50% measured by echocardiography or muga scan;
boolean
C0428772 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2,1])
C0521317 (UMLS CUI [2,2])
Childbearing Potential Serum pregnancy test negative | Informed Consent
Item
15. for women of childbearing potential negative serum pregnancy test12) r. 16. written informed consent.
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
Gender
Item
1. male gender
boolean
C0079399 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
2. pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Prior Therapy Invasive carcinoma of breast Primary
Item
3. received any prior treatment for primary invasive breast cancer
boolean
C1514463 (UMLS CUI [1,1])
C0853879 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
Angina Pectoris Uncontrolled | Angina Pectoris Symptomatic | Cardiac Arrhythmia | Congestive heart failure | Transmural myocardial infarction | Uncontrolled hypertension | Blood pressure determination | Unstable diabetes mellitus | Resting Dyspnea | Oxygen Therapy chronic
Item
4. known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension (> 180/110), unstable diabetes mellitus, dyspnoea at rest or chronic therapy with oxygen;
boolean
C0002962 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0002962 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0003811 (UMLS CUI [3])
C0018802 (UMLS CUI [4])
C1400513 (UMLS CUI [5])
C1868885 (UMLS CUI [6])
C0005824 (UMLS CUI [7])
C0342302 (UMLS CUI [8])
C0743330 (UMLS CUI [9])
C0184633 (UMLS CUI [10,1])
C0205191 (UMLS CUI [10,2])
Communicable Disease | Communicable Disease Uncontrolled
Item
5. active or uncontrolled infection,
boolean
C0009450 (UMLS CUI [1])
C0009450 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Dementia | Abnormal mental state | Mental condition Preventing Informed Consent
Item
6. dementia altered mental status or any psychiatric condition that would prevent the under standing or rendering of icf,
boolean
C0497327 (UMLS CUI [1])
C0278061 (UMLS CUI [2])
C3840291 (UMLS CUI [3,1])
C1292733 (UMLS CUI [3,2])
C0021430 (UMLS CUI [3,3])
Neoadjuvant Therapy Malignant Neoplasm | Chemotherapy | Therapeutic radiology procedure | Immunotherapy | Biological treatment | Exception Investigational Therapy
Item
7. concurrent neoadjuvant cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy other than the trial therapies),
boolean
C0600558 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0021083 (UMLS CUI [4])
C1531518 (UMLS CUI [5])
C1705847 (UMLS CUI [6,1])
C0949266 (UMLS CUI [6,2])
Malignant Neoplasms | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated
Item
8. previous or concomitant malignancy within the past 3 years except adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix.
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
Comorbidity Study Subject Participation Status Inappropriate | Condition Study Subject Participation Status Inappropriate | Disease Interferes with Patient safety
Item
9. concurrent disease or condition that would have make the subject inappropriate for study participation or any serious medical disorder that would interfere with the subject's safety.
boolean
C0009488 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C1548788 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C1113679 (UMLS CUI [3,3])