ID

27333

Beskrivning

6 Weeks Treatment of Locally Advanced Breast Cancer With BIBW 2992 (Afatinib) or Lapatinib or Trastuzumab; ODM derived from: https://clinicaltrials.gov/show/NCT00826267

Länk

https://clinicaltrials.gov/show/NCT00826267

Nyckelord

Versioner (1)
  1. 2017-11-08 2017-11-08 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

8 november 2017

DOI

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Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT00826267

Engelsk

Eligibility Breast Neoplasms NCT00826267

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. female, age 18 years or older.
Beskrivning

Gender | Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
2. histologically proven breast cancer who have not received any prior therapy.
Beskrivning

Breast Carcinoma untreated

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0332155
3. locally advanced disease stage iiia with no evidence of distant metastatic disease other than anatomical site lymph nodes.
Beskrivning

Locally advanced breast cancer TNM Breast tumor staging | Distant metastasis Absent | Exception Secondary malignant neoplasm of lymph node

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3495949
UMLS CUI [1,2]
C0474926
UMLS CUI [2,1]
C1269798
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0686619
4. her2-positive.
Beskrivning

HER2/Neu Positive

Datatyp

boolean

Alias
UMLS CUI [1]
C2348909
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. absolute neutrophil count (anc) less than 1500/mm3.
Beskrivning

Absolute neutrophil count

Datatyp

boolean

Alias
UMLS CUI [1]
C0948762
2. platelet count less than 100 000/ mm3.
Beskrivning

Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0032181
3. hemoglobin level less than 9.0 g/dl.
Beskrivning

Hemoglobin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0518015
4. bilirubin greater than 1.5 mg/di.
Beskrivning

Serum total bilirubin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C1278039
5. aspartate amino transferase (ast) or alanine amino transferase (alt) greater than twice the upper limit of normal.
Beskrivning

Aspartate aminotransferase increased | Alanine aminotransferase increased

Datatyp

boolean

Alias
UMLS CUI [1]
C0151904
UMLS CUI [2]
C0151905
6. serum creatinine greater than 1.5 times of the upper normal limit.
Beskrivning

Serum creatinine raised

Datatyp

boolean

Alias
UMLS CUI [1]
C0700225
7. significant or recent acute gastrointestinal disorders with diarrhea
Beskrivning

Gastrointestinal Diseases | Diarrhea

Datatyp

boolean

Alias
UMLS CUI [1]
C0017178
UMLS CUI [2]
C0011991
8. pregnancy or breast-feeding.
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
9. organ system dysfunction including cardiac (lvef < 50%).
Beskrivning

Organ system Dysfunction | Cardiac dysfunction | Left ventricular ejection fraction

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0460002
UMLS CUI [1,2]
C3887504
UMLS CUI [2]
C3277906
UMLS CUI [3]
C0428772
10. prior chemotherapy, radiotherapy or hormone therapy. previous treatment with trastuzumab, egfr, or egfr/her2-inhibitors.
Beskrivning

Prior Chemotherapy | Prior radiation therapy | Prior Hormone Therapy | Trastuzumab | EGFR | EGFR inhibitor | HER2 inhibitors

Datatyp

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2]
C0279134
UMLS CUI [3]
C1514460
UMLS CUI [4]
C0728747
UMLS CUI [5]
C0034802
UMLS CUI [6]
C1443775
UMLS CUI [7]
C2916795
11. other malignancies diagnosed within the past five years.
Beskrivning

Cancer Other

Datatyp

boolean

Alias
UMLS CUI [1]
C1707251
12. serious active infection. hiv, active hepatitis b or c.
Beskrivning

Communicable Disease Serious | HIV Infection | Hepatitis B | Hepatitis C

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0019693
UMLS CUI [3]
C0019163
UMLS CUI [4]
C0019196
Tillbaka till toppen

Similar models

Eligibility Breast Neoplasms NCT00826267

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
1. female, age 18 years or older.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Breast Carcinoma untreated
Item
2. histologically proven breast cancer who have not received any prior therapy.
boolean
C0678222 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
Locally advanced breast cancer TNM Breast tumor staging | Distant metastasis Absent | Exception Secondary malignant neoplasm of lymph node
Item
3. locally advanced disease stage iiia with no evidence of distant metastatic disease other than anatomical site lymph nodes.
boolean
C3495949 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
C1269798 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0686619 (UMLS CUI [3,2])
HER2/Neu Positive
Item
4. her2-positive.
boolean
C2348909 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Absolute neutrophil count
Item
1. absolute neutrophil count (anc) less than 1500/mm3.
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
2. platelet count less than 100 000/ mm3.
boolean
C0032181 (UMLS CUI [1])
Hemoglobin measurement
Item
3. hemoglobin level less than 9.0 g/dl.
boolean
C0518015 (UMLS CUI [1])
Serum total bilirubin measurement
Item
4. bilirubin greater than 1.5 mg/di.
boolean
C1278039 (UMLS CUI [1])
Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
5. aspartate amino transferase (ast) or alanine amino transferase (alt) greater than twice the upper limit of normal.
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
Serum creatinine raised
Item
6. serum creatinine greater than 1.5 times of the upper normal limit.
boolean
C0700225 (UMLS CUI [1])
Gastrointestinal Diseases | Diarrhea
Item
7. significant or recent acute gastrointestinal disorders with diarrhea
boolean
C0017178 (UMLS CUI [1])
C0011991 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
8. pregnancy or breast-feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Organ system Dysfunction | Cardiac dysfunction | Left ventricular ejection fraction
Item
9. organ system dysfunction including cardiac (lvef < 50%).
boolean
C0460002 (UMLS CUI [1,1])
C3887504 (UMLS CUI [1,2])
C3277906 (UMLS CUI [2])
C0428772 (UMLS CUI [3])
Prior Chemotherapy | Prior radiation therapy | Prior Hormone Therapy | Trastuzumab | EGFR | EGFR inhibitor | HER2 inhibitors
Item
10. prior chemotherapy, radiotherapy or hormone therapy. previous treatment with trastuzumab, egfr, or egfr/her2-inhibitors.
boolean
C1514457 (UMLS CUI [1])
C0279134 (UMLS CUI [2])
C1514460 (UMLS CUI [3])
C0728747 (UMLS CUI [4])
C0034802 (UMLS CUI [5])
C1443775 (UMLS CUI [6])
C2916795 (UMLS CUI [7])
Cancer Other
Item
11. other malignancies diagnosed within the past five years.
boolean
C1707251 (UMLS CUI [1])
Communicable Disease Serious | HIV Infection | Hepatitis B | Hepatitis C
Item
12. serious active infection. hiv, active hepatitis b or c.
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0019693 (UMLS CUI [2])
C0019163 (UMLS CUI [3])
C0019196 (UMLS CUI [4])
Tillbaka till toppen 

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