Breast Carcinoma Operable | Locally advanced breast cancer | Inflammatory Breast Carcinoma
Item
1. histologically-confirmed breast cancer (operable, locally advanced or inflammatory)
boolean
C0678222 (UMLS CUI [1,1])
C0205188 (UMLS CUI [1,2])
C3495949 (UMLS CUI [2])
C0278601 (UMLS CUI [3])
Age
Item
2. age less than 70 years
boolean
C0001779 (UMLS CUI [1])
Gender
Item
3. female patient
boolean
C0079399 (UMLS CUI [1])
Tumor size | Ultrasound examination
Item
4. tumor size 2 cm at ultrasound examination.
boolean
C0475440 (UMLS CUI [1])
C0948501 (UMLS CUI [2])
Estrogen receptor negative neoplasm | Immunohistochemistry | percent positive cells
Item
5. er-negative tumors defined according to immunohistochemistry (i.e. < 10% of positive cells after immunostaining).
boolean
C2584629 (UMLS CUI [1])
C0021044 (UMLS CUI [2])
C0439178 (UMLS CUI [3])
Multifocal breast carcinoma | Multicentric Breast Carcinoma | Foci Estrogen receptor negative
Item
6. multifocal and multicentric breast tumors are allowed if all foci are er-negative.
boolean
C2986662 (UMLS CUI [1])
C2986664 (UMLS CUI [2])
C0205234 (UMLS CUI [3,1])
C0279756 (UMLS CUI [3,2])
primary tumor Fixed Specimen | primary tumor Frozen Specimen | Epirubicin | Biological Markers Evaluation | TOP2A gene | DNA topoisomerase II alpha | ERBB2 gene | TP53 gene | Oligonucleotide Arrays
Item
7. fixed and frozen samples from the primary tumor, obtained before treatment with epirubicin, must be available for evaluation of biological markers (topo ii alpha gene and protein, her-2 gene, p-53 gene, oligonucleotides microarrays).
boolean
C0677930 (UMLS CUI [1,1])
C2827483 (UMLS CUI [1,2])
C0677930 (UMLS CUI [2,1])
C1548793 (UMLS CUI [2,2])
C0014582 (UMLS CUI [3])
C0005516 (UMLS CUI [4,1])
C1261322 (UMLS CUI [4,2])
C1336657 (UMLS CUI [5])
C0256022 (UMLS CUI [6])
C0242957 (UMLS CUI [7])
C0079419 (UMLS CUI [8])
C0600597 (UMLS CUI [9])
Informed consent
Item
8. written informed consent before study registration.
boolean
C0021430 (UMLS CUI [1])
ECOG performance status
Item
9. performance status 0 or 1 (ecog scale)
boolean
C1520224 (UMLS CUI [1])
Complete Blood Count | Liver function | Renal function
Item
10. normal cbc, hepatic and renal functions
boolean
C0009555 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Left ventricular ejection fraction | Echocardiography | Multiple gated acquisition scanning
Item
11. normal left ventricular ejection fraction by echocardiography or muga scan
boolean
C0428772 (UMLS CUI [1])
C0013516 (UMLS CUI [2])
C0521317 (UMLS CUI [3])
Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods | Hormonal contraception
Item
12. negative pregnancy test for all women of childbearing potential. patients of childbearing potential must implement adequate non-hormonal measures to avoid pregnancy during treatment.
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C2985296 (UMLS CUI [3])
Carcinoma breast stage IV
Item
1. metastatic breast cancer
boolean
C0278488 (UMLS CUI [1])
medical condition Serious
Item
2. serious medical conditions like:
boolean
C3843040 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Congestive heart failure | Angina, Unstable | Myocardial Infarction | Cardiac Arrhythmia Uncontrolled
Item
1. congestive heart failure or unstable angina pectoris, previous history of myocardial infarction within 1 year from study entry, uncontrolled arrhythmias.
boolean
C0018802 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0003811 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
nervous system disorder Significant | Mental disorders Significant
Item
2. history of significant neurologic or psychiatric disorders
boolean
C0027765 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0004936 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
Communicable Diseases Uncontrolled
Item
3. active uncontrolled infection
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Peptic Ulcer | Brittle diabetes
Item
4. active peptic ulcer, unstable diabetes mellitus
boolean
C0030920 (UMLS CUI [1])
C0342302 (UMLS CUI [2])
Contralateral breast cancer Invasive
Item
3. concomitant contralateral invasive breast cancer
boolean
C1096616 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
Hormone replacement therapy
Item
4. concurrent treatment with hormonal replacement therapy
boolean
C0282402 (UMLS CUI [1])
cancer treatment
Item
5. concurrent treatment with any other anti-cancer therapy
boolean
C0920425 (UMLS CUI [1])
prior anthracycline therapy Breast Carcinoma
Item
6. previous treatment with anthracyclines for breast cancer
boolean
C0278941 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])