Patient initial
Item
PATIENT INT.
text
C2986440 (UMLS CUI [1])
Patient id
Item
PATIENT SCREENING NUMBER
text
C2348585 (UMLS CUI [1])
date
Item
DATE:
date
C0011008 (UMLS CUI [1])
gender; age
Item
1 PATIENT IS FEMALE AGE 18 OR OLDER.
boolean
C0079399 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
histology Breast cancer metastasis
Item
2. HISTOLOGICALLY CONFIRMED METASTATIC BREAST CANCER.
boolean
C0019638 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
histology Breast cancer metastasis; IMMUNOHISTOCHEMISTRY HER2
Item
3. HISTOLOGICALLY DOCUMENTED PRIMARY BREAST CANCER OR BIOPSY OF METASTATIC SITE SHOW· ING 2+ TO 3+ OVEREXPRESSION OF THE HER2 ONCOGENE BY IMMUNOHISTOCHEMISTRY.
boolean
C0019638 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
C0021044 (UMLS CUI [2,1])
C0941291 (UMLS CUI [2,2])
Diagnostic radiologic examination; Physical Examination; Bone Diseases
Item
4 BIOIMENSIONALLY MEASURABLE DISEASE BY RADIOGRAPHIC MEANS OR PHYSICAL EXAMINATION · NOT BONE DISEASE ALONE.
boolean
C0043299 (UMLS CUI [1])
C0031809 (UMLS CUI [2])
C0005940 (UMLS CUI [3])
informed consent; chemotherapy; monoclonal antibody
Item
5. THE ABILITY TO UNDERSTAND AND WILLINGNESS TO SIGN AN INFORMED CONSENT FORM.
boolean
C0021430 (UMLS CUI [1])
C3665472 (UMLS CUI [2])
C0003250 (UMLS CUI [3])
CHEMOTHERAPY METASTATIC BREAST CANCER
Item
6 PRlOR CYTOTOXIC CHEMOTHERAPY FOR METASTATIC BREAST CANCER .
boolean
C0392920 (UMLS CUI [1,1])
C0278488 (UMLS CUI [1,2])
cardiac disease NYHA III or IV Decompensated congestive heart failure Myocardial Infarction
Item
7. CLINICALLY SIGNIFICANT ACTIVE CARDIAC DISEASE. I.E., NEW YORK HEART ASSOCIATION CLASS III OR IV, DECOMPENSATED CONGESTIVE HEART FAILURE, OR HISTORY OF MYOCARDIAL INFARCTION WITHIN 3 MONTHS OF STUDY ENTRY .
boolean
C0018799 (UMLS CUI [1,1])
C0278962 (UMLS CUI [1,2])
C0742746 (UMLS CUI [1,3])
C0027051 (UMLS CUI [1,4])
INFECTIONS ACTIVE
Item
8 CLINICALLY SIGNIFICANT ACTIVE INFECTIONS.
boolean
C0009450 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
Hemorrhagic Disorders
Item
9. KNOWN HEMORRHAGIC DIATHESIS OR ACTIVE BLEEDING DISORDER.
boolean
C0019087 (UMLS CUI [1])
pregnancy; breast feeding; contraception
Item
10. PREGNANT OR NURSING WOMEN; WOMEN OF CHILDBEARING POTENTIAL UNLESS USING EFFECTIVE CONTRACEPTION AS DETERMINED BY THE INVESTIGATOR.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
BILATERAL BREAST CANCER; Her2 positive
Item
11. BILATERAL BREAST CANCER. UNLESS BOTH PRIMARY TUMORS HAVE 2+ TO 3+ HER2 OVEREXPRESSION.
boolean
C0281267 (UMLS CUI [1])
C1960398 (UMLS CUI [2])
Brain Neoplasms Leptomeningeal metastasis
Item
12. HISTORY OF BRAIN OR LEPTOMENINGEAL METASTATIC DISEASE.
boolean
C0006118 (UMLS CUI [1,1])
C1704231 (UMLS CUI [1,2])
BONE METASTASES
Item
13. BONE METASTASES AS THE ONLY SITE OF MEASURABLE AND EVALUABLE DISEASE.
boolean
C0153690 (UMLS CUI [1])
Liver metastases
Item
14. LIVER METASTASES> 30% OF HEPATIC PARENCHYMA
boolean
C0494165 (UMLS CUI [1])
CONCOMITANT MALIGNANCY; Basal cell carcinoma; Carcinoma in situ of uterine cervix
Item
15. PREVIOUS OR CONCOMITANT MALIGNANCY OTHER THAN CURATIVELY TREATED CARCINOMA IN SITU OF CERVIX OR BASAL CELL CARCINOMA OF SKIN.
boolean
C0009488 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C0007117 (UMLS CUI [2])
C0851140 (UMLS CUI [3])
Karnofsky Performance Status
Item
16. A PERFORMANCE STATUS OF< 70% ON THE KARNOFSKY SCALE.
boolean
C0206065 (UMLS CUI [1])
RENAL FUNCTION Creatinine Proteinuria
Item
17. RENAL FUNCTION: CREATININE >= 1.7 mg/dL (150 µmol/L); >= 2+ PROTEINURIA.
boolean
C0201976 (UMLS CUI [1,1])
C0373595 (UMLS CUI [1,2])
C0033687 (UMLS CUI [1,3])
Life expectancy limited
Item
18. A LIFE EXPECTANCY OF LESS THAN 6 MONTHS.
boolean
C0023671 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
Liver function bilirubin prothrombin time
Item
19. HEPATIC FUNCTION: BILIRUBIN >= 1.5 mg/dL (25.7 µmol/L), PROTHROMBIN TIME > 15 SEC.
boolean
C0232741 (UMLS CUI [1,1])
C0201913 (UMLS CUI [1,2])
C0033707 (UMLS CUI [1,3])
Hematologic Tests WBC Granulocytes Platelets Hemoglobin
Item
20. HEMATOLOGIC STATUS: WBC <= 3500/mm^3 (3.5 x 10^9/L); GRANULOCYTES <=1500/mm^3 (1.5 x 10^9/L); PLATELETS <= 100,000/mm^3 (100 x 10^9.); Hgb<= 10 g/dL (6.2 mmol/L).
boolean
C0018941 (UMLS CUI [1,1])
C0023508 (UMLS CUI [1,2])
C0857490 (UMLS CUI [1,3])
C0032181 (UMLS CUI [1,4])
C0518015 (UMLS CUI [1,5])
Lung function Forced expiratory volume function Peak expiratory flow rate measurement
Item
21. PULMONARY FUNCTION: FEV, OR PEFR < 70% OF PREDICTED VALUE.
boolean
C0024119 (UMLS CUI [1,1])
C0016529 (UMLS CUI [1,2])
C0030735 (UMLS CUI [1,3])
SERUM CALCIUM
Item
22. ELEVATED SERUM CALCIUM (>= 11.0 mg/dL) (2.7 mmol/L).
boolean
C0036785 (UMLS CUI [1])
RADIOTHERAPY
Item
23. RADIOTHERAPY WITHIN 2 WEEKS PRIOR TO STUDY ENTRY.
boolean
C1522449 (UMLS CUI [1])
previous therapy Monoclonal Antibodies Polyclonal antibody
Item
24. PREVlOUS THERAPY WITH A MONOCLONAL OR POLYCLONAL ANTIBODY.
boolean
C1514463 (UMLS CUI [1,1])
C0003250 (UMLS CUI [1,2])
C0312586 (UMLS CUI [1,3])
Medication Breast cancer
Item
25. ANY INYESTIGATIONAL OR UNLICENSED AGENTS FOR METASTATIC BREAST CANCER.
boolean
C0013227 (UMLS CUI [1,1])
C0006142 (UMLS CUI [1,2])
CYTOKINE THERAPY
Item
26. ANY PRIOR CYTOKINE THERAPY FOR CANCER.
boolean
C0199974 (UMLS CUI [1])
HORMONAL THERAPY MEGESTROL ACETATE AMINOGLUTETHIMIDE
Item
27. ANY HORMONAL THERAPY SUCH AS TAMOXIFEN. MEGESTROL ACETATE, FLUOXYMESTEAONE OR AMINOGLUTETHIMIDE WITHIN 2 WEEKS PRIOR TO STUDY ENTRY.
boolean
C0279025 (UMLS CUI [1,1])
C0065879 (UMLS CUI [1,2])
C0002555 (UMLS CUI [1,3])