ID

19736

Descripción

Preliminary Study of Mycograb and Docetaxel in Advanced Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00217815

Link

https://clinicaltrials.gov/show/NCT00217815

Palabras clave

Versiones (1)
  1. 24/1/17 24/1/17 -
Subido en

24 de enero de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Cancer of the Breast NCT00217815

Inglés

Eligibility Cancer of the Breast NCT00217815

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients must be female between the ages of 18 to 70 years old.
Descripción

Gender | Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
2. patients must have histologically or clinically confirmed metastatic and/or recurrent breast cancer amenable to treatment with docetaxel.
Descripción

Secondary malignant neoplasm of female breast Amenable docetaxel | Breast cancer recurrent Amenable docetaxel

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0346993
UMLS CUI [1,2]
C3900053
UMLS CUI [1,3]
C0246415
UMLS CUI [2,1]
C0278493
UMLS CUI [2,2]
C3900053
UMLS CUI [2,3]
C0246415
3. patients must have presence of at least one uni-dimensional measurable lesion with minimal lesion size > 20 mm at the largest diameter.
Descripción

Measurable Disease Linear Quantity | Lesion size Minimal Diameter Largest

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0205132
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0449453
UMLS CUI [2,2]
C0547040
UMLS CUI [2,3]
C1301886
UMLS CUI [2,4]
C0443228
4. patients may have had one previous chemotherapy regimen and must not have received prior chemotherapy with docetaxel.
Descripción

Chemotherapy Regimen Quantity | Chemotherapy docetaxel

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0246415
5. patients must have been off all hormonal therapy for at least 2 weeks prior to initiation of therapy.
Descripción

Hormone Therapy Discontinued

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C1444662
6. patients must have been off all chemotherapy or radiotherapy regimens for at least 4 weeks prior to initiation of chemotherapy.
Descripción

Chemotherapy Discontinued | Therapeutic radiology procedure Discontinued

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1444662
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C1444662
7. patients must have a life expectancy of at least 6 months.
Descripción

Life Expectancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023671
8. patients must have a ecog status of 0, 1 or 2.
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
9. patients must be willing to complete all procedures and visits as outlined in the protocol.
Descripción

Protocol Compliance

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0525058
10. patients must sign an informed consent form.
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
11. patients must have negative blood test for hiv and hepatitis b and c.
Descripción

Hematologic Test Negative HIV Infection | Hematologic Test Negative Hepatitis B | Hematologic Test Negative Hepatitis C

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C1513916
UMLS CUI [1,3]
C0019693
UMLS CUI [2,1]
C0018941
UMLS CUI [2,2]
C1513916
UMLS CUI [2,3]
C0019163
UMLS CUI [3,1]
C0018941
UMLS CUI [3,2]
C1513916
UMLS CUI [3,3]
C0019196
12. female patients of child bearing potential should use an effective method of contraception.
Descripción

Childbearing Potential Contraceptive method

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients with brain or meningeal metastases.
Descripción

Metastatic malignant neoplasm to brain | Metastatic Malignant Neoplasm to the Leptomeninges

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2]
C1704231
2. patients whose only measurable lesion is in the bone.
Descripción

Measurable Disease only bone

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0205171
UMLS CUI [1,3]
C0262950
3. patients with clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, respiratory, neurologic, psychiatric, immunologic, gastrointestinal, hematologic, metabolic or any other condition or laboratory abnormality that in the opinion of the investigator makes the patient unsuitable for participation in the study.
Descripción

Cardiovascular Diseases Clinical Significance | Lung diseases | Kidney Diseases | Endocrine System Diseases | Liver diseases | Respiration Disorders | nervous system disorder | Mental disorders | Immune System Diseases | Gastrointestinal Diseases | Hematological Disease | Metabolic Diseases | Condition Study Subject Participation Status Inappropriate | Laboratory test result abnormal Study Subject Participation Status Inappropriate

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C2826293
UMLS CUI [2]
C0024115
UMLS CUI [3]
C0022658
UMLS CUI [4]
C0014130
UMLS CUI [5]
C0023895
UMLS CUI [6]
C0035204
UMLS CUI [7]
C0027765
UMLS CUI [8]
C0004936
UMLS CUI [9]
C0021053
UMLS CUI [10]
C0017178
UMLS CUI [11]
C0018939
UMLS CUI [12]
C0025517
UMLS CUI [13,1]
C0348080
UMLS CUI [13,2]
C2348568
UMLS CUI [13,3]
C1548788
UMLS CUI [14,1]
C0438215
UMLS CUI [14,2]
C2348568
UMLS CUI [14,3]
C1548788
4. patients with history of seizure disorder.
Descripción

Epilepsy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0014544
5. patients who have received treatment with any other investigational drug within the preceding one month.
Descripción

Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013230
6. patients who are pregnant or breast feeding.
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Cancer of the Breast NCT00217815

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
1. patients must be female between the ages of 18 to 70 years old.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Secondary malignant neoplasm of female breast Amenable docetaxel | Breast cancer recurrent Amenable docetaxel
Item
2. patients must have histologically or clinically confirmed metastatic and/or recurrent breast cancer amenable to treatment with docetaxel.
boolean
C0346993 (UMLS CUI [1,1])
C3900053 (UMLS CUI [1,2])
C0246415 (UMLS CUI [1,3])
C0278493 (UMLS CUI [2,1])
C3900053 (UMLS CUI [2,2])
C0246415 (UMLS CUI [2,3])
Measurable Disease Linear Quantity | Lesion size Minimal Diameter Largest
Item
3. patients must have presence of at least one uni-dimensional measurable lesion with minimal lesion size > 20 mm at the largest diameter.
boolean
C1513041 (UMLS CUI [1,1])
C0205132 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0449453 (UMLS CUI [2,1])
C0547040 (UMLS CUI [2,2])
C1301886 (UMLS CUI [2,3])
C0443228 (UMLS CUI [2,4])
Chemotherapy Regimen Quantity | Chemotherapy docetaxel
Item
4. patients may have had one previous chemotherapy regimen and must not have received prior chemotherapy with docetaxel.
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C0246415 (UMLS CUI [2,2])
Hormone Therapy Discontinued
Item
5. patients must have been off all hormonal therapy for at least 2 weeks prior to initiation of therapy.
boolean
C0279025 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
Chemotherapy Discontinued | Therapeutic radiology procedure Discontinued
Item
6. patients must have been off all chemotherapy or radiotherapy regimens for at least 4 weeks prior to initiation of chemotherapy.
boolean
C0392920 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
Life Expectancy
Item
7. patients must have a life expectancy of at least 6 months.
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
8. patients must have a ecog status of 0, 1 or 2.
boolean
C1520224 (UMLS CUI [1])
Protocol Compliance
Item
9. patients must be willing to complete all procedures and visits as outlined in the protocol.
boolean
C0525058 (UMLS CUI [1])
Informed Consent
Item
10. patients must sign an informed consent form.
boolean
C0021430 (UMLS CUI [1])
Hematologic Test Negative HIV Infection | Hematologic Test Negative Hepatitis B | Hematologic Test Negative Hepatitis C
Item
11. patients must have negative blood test for hiv and hepatitis b and c.
boolean
C0018941 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
C0019693 (UMLS CUI [1,3])
C0018941 (UMLS CUI [2,1])
C1513916 (UMLS CUI [2,2])
C0019163 (UMLS CUI [2,3])
C0018941 (UMLS CUI [3,1])
C1513916 (UMLS CUI [3,2])
C0019196 (UMLS CUI [3,3])
Childbearing Potential Contraceptive method
Item
12. female patients of child bearing potential should use an effective method of contraception.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Metastatic malignant neoplasm to brain | Metastatic Malignant Neoplasm to the Leptomeninges
Item
1. patients with brain or meningeal metastases.
boolean
C0220650 (UMLS CUI [1])
C1704231 (UMLS CUI [2])
Measurable Disease only bone
Item
2. patients whose only measurable lesion is in the bone.
boolean
C1513041 (UMLS CUI [1,1])
C0205171 (UMLS CUI [1,2])
C0262950 (UMLS CUI [1,3])
Cardiovascular Diseases Clinical Significance | Lung diseases | Kidney Diseases | Endocrine System Diseases | Liver diseases | Respiration Disorders | nervous system disorder | Mental disorders | Immune System Diseases | Gastrointestinal Diseases | Hematological Disease | Metabolic Diseases | Condition Study Subject Participation Status Inappropriate | Laboratory test result abnormal Study Subject Participation Status Inappropriate
Item
3. patients with clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, respiratory, neurologic, psychiatric, immunologic, gastrointestinal, hematologic, metabolic or any other condition or laboratory abnormality that in the opinion of the investigator makes the patient unsuitable for participation in the study.
boolean
C0007222 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0024115 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0014130 (UMLS CUI [4])
C0023895 (UMLS CUI [5])
C0035204 (UMLS CUI [6])
C0027765 (UMLS CUI [7])
C0004936 (UMLS CUI [8])
C0021053 (UMLS CUI [9])
C0017178 (UMLS CUI [10])
C0018939 (UMLS CUI [11])
C0025517 (UMLS CUI [12])
C0348080 (UMLS CUI [13,1])
C2348568 (UMLS CUI [13,2])
C1548788 (UMLS CUI [13,3])
C0438215 (UMLS CUI [14,1])
C2348568 (UMLS CUI [14,2])
C1548788 (UMLS CUI [14,3])
Epilepsy
Item
4. patients with history of seizure disorder.
boolean
C0014544 (UMLS CUI [1])
Investigational New Drugs
Item
5. patients who have received treatment with any other investigational drug within the preceding one month.
boolean
C0013230 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
6. patients who are pregnant or breast feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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