ID

27333

Descripción

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

Link

https://clinicaltrials.gov/show/NCT00826267

Palabras clave

Versiones (1)
  1. 8/11/17 8/11/17 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

8 de noviembre de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT00826267

Inglés

Eligibility Breast Neoplasms NCT00826267

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

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

Gender | Age

Tipo de datos

boolean

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

Breast Carcinoma untreated

Tipo de datos

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.
Descripción

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

Tipo de datos

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.
Descripción

HER2/Neu Positive

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348909
Exclusion Criteria
Descripción

Exclusion Criteria

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

Absolute neutrophil count

Tipo de datos

boolean

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

Platelet Count measurement

Tipo de datos

boolean

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

Hemoglobin measurement

Tipo de datos

boolean

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

Serum total bilirubin measurement

Tipo de datos

boolean

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

Aspartate aminotransferase increased | Alanine aminotransferase increased

Tipo de datos

boolean

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

Serum creatinine raised

Tipo de datos

boolean

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

Gastrointestinal Diseases | Diarrhea

Tipo de datos

boolean

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

Pregnancy | Breast Feeding

Tipo de datos

boolean

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

Organ system Dysfunction | Cardiac dysfunction | Left ventricular ejection fraction

Tipo de datos

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.
Descripción

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

Tipo de datos

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.
Descripción

Cancer Other

Tipo de datos

boolean

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

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

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0019693
UMLS CUI [3]
C0019163
UMLS CUI [4]
C0019196
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Similar models

Eligibility Breast Neoplasms NCT00826267

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
Volver a la parte superior de la página 

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