ID

43788

Description

Study part: Patient eligibility worksheet. A phase III multinational, randomized, single-blind study of recombinant humanized anti-p185HER2 monoclonal antibody (rhuMAb HER2) in patients with HER2/neu overexpression who have not received prior cytotoxic chemotherapy for metastatic breast cancer. "Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche"

Keywords

Versions (2)
  1. 5/14/17 5/14/17 -
  2. 9/20/21 9/20/21 -
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Roche

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September 20, 2021

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PATIENT ELIGIBILITY WORKSHEET Roche H0650g Breast Cancer

English

PATIENT ELIGIBILITY WORKSHEET

1 forms  
INCLUSION CRITERIA
Description

INCLUSION CRITERIA

Alias
UMLS CUI-1
C1512693
PATIENT INT.
Description

Patient initial

Data type

text

Alias
UMLS CUI [1]
C2986440
PATIENT SCREENING NUMBER
Description

Patient id

Data type

text

Alias
UMLS CUI [1]
C2348585
DATE:
Description

date

Data type

date

Alias
UMLS CUI [1]
C0011008
1 PATIENT IS FEMALE AGE 18 OR OLDER.
Description

gender; age

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0001779
2. HISTOLOGICALLY CONFIRMED METASTATIC BREAST CANCER.
Description

histology Breast cancer metastasis

Data type

boolean

Alias
UMLS CUI [1,1]
C0019638
UMLS CUI [1,2]
C0678222
UMLS CUI [1,3]
C0027627
3. HISTOLOGICALLY DOCUMENTED PRIMARY BREAST CANCER OR BIOPSY OF METASTATIC SITE SHOW· ING 2+ TO 3+ OVEREXPRESSION OF THE HER2 ONCOGENE BY IMMUNOHISTOCHEMISTRY.
Description

histology Breast cancer metastasis; IMMUNOHISTOCHEMISTRY HER2

Data type

boolean

Alias
UMLS CUI [1,1]
C0019638
UMLS CUI [1,2]
C0678222
UMLS CUI [1,3]
C0027627
UMLS CUI [2,1]
C0021044
UMLS CUI [2,2]
C0941291
4 BIOIMENSIONALLY MEASURABLE DISEASE BY RADIOGRAPHIC MEANS OR PHYSICAL EXAMINATION · NOT BONE DISEASE ALONE.
Description

MEASURABLE DISEASE IS DEFINED AS ANY MASS REPRODUCIBLY MEASURABLE IN TWO PERPENDICU- LAR DIAMETERS BY PHYSICAL EXAMINATION, X-RAY (PLAIN FILMS}, COMPUTERIZED TOMOGRAPHY (CT). MAGNETIC RESONANCE IMAGING (MRI}, OR ULTRASOUND. LESIONS ON BONE SCAN, OSTEOBLAS- TIC METASTASES, AND PLEURAL OR PERITONEAL EFFUSIONS ARE NOT CONSIDERED TO BE MEASUR· ABLE. MEASURABLE LESIONS MUST BE AT LEAST 1 cm IN GREATEST DIMENSION. ENUMERATION OF EVALUABLE SITES OF METASTATIC DISEASE AND NUMBER OF LESIONS IN AN EVALUABLE SITE (E.G .. LUNG) MUST BE RECORDED ON THE APPROPRIATE CASE REPORT FORM (CRF). IF A LARGER NUMBER OF PULMONARY OR HEPATIC LESIONS ARE PRESENT. THE SIX LARGEST LESIONS PER SITE WILL BE FOLLOWED.

Data type

boolean

Alias
UMLS CUI [1]
C0043299
UMLS CUI [2]
C0031809
UMLS CUI [3]
C0005940
5. THE ABILITY TO UNDERSTAND AND WILLINGNESS TO SIGN AN INFORMED CONSENT FORM.
Description

THE PATIENT MUST HAVE DECLINED CYTOTOXIC CHEMOTHERAPY FOLLOWING A DETAILED DISCUSSION OF THERAPEUTIC OPTIONS WITH THE PHYSICIAN-INVESTIGATOR. PATIENTS MUST COMPREHEND THAT THEY ARE PARTICIPATING IN A TRIAL THAT IS UTILIZING A MONOCLONAL ANTIBODY RATHER THAN CHEMOTHERAPY.

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C3665472
UMLS CUI [3]
C0003250
EXCLUSION CRITERIA
Description

EXCLUSION CRITERIA

Alias
UMLS CUI-1
C0680251
6 PRlOR CYTOTOXIC CHEMOTHERAPY FOR METASTATIC BREAST CANCER .
Description

CHEMOTHERAPY METASTATIC BREAST CANCER

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0278488
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 .
Description

cardiac disease NYHA III or IV Decompensated congestive heart failure Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0278962
UMLS CUI [1,3]
C0742746
UMLS CUI [1,4]
C0027051
8 CLINICALLY SIGNIFICANT ACTIVE INFECTIONS.
Description

INFECTIONS ACTIVE

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205177
9. KNOWN HEMORRHAGIC DIATHESIS OR ACTIVE BLEEDING DISORDER.
Description

Hemorrhagic Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0019087
10. PREGNANT OR NURSING WOMEN; WOMEN OF CHILDBEARING POTENTIAL UNLESS USING EFFECTIVE CONTRACEPTION AS DETERMINED BY THE INVESTIGATOR.
Description

pregnancy; breast feeding; contraception

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0700589
11. BILATERAL BREAST CANCER. UNLESS BOTH PRIMARY TUMORS HAVE 2+ TO 3+ HER2 OVEREXPRESSION.
Description

BILATERAL BREAST CANCER; Her2 positive

Data type

boolean

Alias
UMLS CUI [1]
C0281267
UMLS CUI [2]
C1960398
12. HISTORY OF BRAIN OR LEPTOMENINGEAL METASTATIC DISEASE.
Description

Brain Neoplasms Leptomeningeal metastasis

Data type

boolean

Alias
UMLS CUI [1,1]
C0006118
UMLS CUI [1,2]
C1704231
13. BONE METASTASES AS THE ONLY SITE OF MEASURABLE AND EVALUABLE DISEASE.
Description

BONE METASTASES

Data type

boolean

Alias
UMLS CUI [1]
C0153690
14. LIVER METASTASES> 30% OF HEPATIC PARENCHYMA
Description

Liver metastases

Data type

boolean

Alias
UMLS CUI [1]
C0494165
15. PREVIOUS OR CONCOMITANT MALIGNANCY OTHER THAN CURATIVELY TREATED CARCINOMA IN SITU OF CERVIX OR BASAL CELL CARCINOMA OF SKIN.
Description

CONCOMITANT MALIGNANCY; Basal cell carcinoma; Carcinoma in situ of uterine cervix

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0006826
UMLS CUI [2]
C0007117
UMLS CUI [3]
C0851140
16. A PERFORMANCE STATUS OF< 70% ON THE KARNOFSKY SCALE.
Description

Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
17. RENAL FUNCTION: CREATININE >= 1.7 mg/dL (150 µmol/L); >= 2+ PROTEINURIA.
Description

RENAL FUNCTION Creatinine Proteinuria

Data type

boolean

Alias
UMLS CUI [1,1]
C0201976
UMLS CUI [1,2]
C0373595
UMLS CUI [1,3]
C0033687
18. A LIFE EXPECTANCY OF LESS THAN 6 MONTHS.
Description

Life expectancy limited

Data type

boolean

Alias
UMLS CUI [1,1]
C0023671
UMLS CUI [1,2]
C0439801
19. HEPATIC FUNCTION: BILIRUBIN >= 1.5 mg/dL (25.7 µmol/L), PROTHROMBIN TIME > 15 SEC.
Description

Liver function bilirubin prothrombin time

Data type

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C0201913
UMLS CUI [1,3]
C0033707
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).
Description

Hematologic Tests WBC Granulocytes Platelets Hemoglobin

Data type

boolean

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0023508
UMLS CUI [1,3]
C0857490
UMLS CUI [1,4]
C0032181
UMLS CUI [1,5]
C0518015
21. PULMONARY FUNCTION: FEV, OR PEFR < 70% OF PREDICTED VALUE.
Description

Lung function Forced expiratory volume function Peak expiratory flow rate measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0024119
UMLS CUI [1,2]
C0016529
UMLS CUI [1,3]
C0030735
22. ELEVATED SERUM CALCIUM (>= 11.0 mg/dL) (2.7 mmol/L).
Description

SERUM CALCIUM

Data type

boolean

Alias
UMLS CUI [1]
C0036785
23. RADIOTHERAPY WITHIN 2 WEEKS PRIOR TO STUDY ENTRY.
Description

RADIOTHERAPY

Data type

boolean

Alias
UMLS CUI [1]
C1522449
EXCLUDED PREADMISSION THERAPY OR MEDICATION
Description

EXCLUDED PREADMISSION THERAPY OR MEDICATION

Alias
UMLS CUI-1
C2114510
UMLS CUI-3
C2826667
24. PREVlOUS THERAPY WITH A MONOCLONAL OR POLYCLONAL ANTIBODY.
Description

previous therapy Monoclonal Antibodies Polyclonal antibody

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0003250
UMLS CUI [1,3]
C0312586
25. ANY INYESTIGATIONAL OR UNLICENSED AGENTS FOR METASTATIC BREAST CANCER.
Description

Medication Breast cancer

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0006142
26. ANY PRIOR CYTOKINE THERAPY FOR CANCER.
Description

CYTOKINE THERAPY

Data type

boolean

Alias
UMLS CUI [1]
C0199974
27. ANY HORMONAL THERAPY SUCH AS TAMOXIFEN. MEGESTROL ACETATE, FLUOXYMESTEAONE OR AMINOGLUTETHIMIDE WITHIN 2 WEEKS PRIOR TO STUDY ENTRY.
Description

HORMONAL THERAPY MEGESTROL ACETATE AMINOGLUTETHIMIDE

Data type

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C0065879
UMLS CUI [1,3]
C0002555
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Similar models

PATIENT ELIGIBILITY WORKSHEET

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
INCLUSION CRITERIA
C1512693 (UMLS CUI-1)
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])
Item Group
EXCLUSION CRITERIA
C0680251 (UMLS CUI-1)
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])
Item Group
EXCLUDED PREADMISSION THERAPY OR MEDICATION
C2114510 (UMLS CUI-1)
C2826667 (UMLS CUI-3)
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])
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