ID

38172

Descripción

Nimotuzumab Plus Docetaxel and Capecitabine Versus Docetaxel and Capecitabine in the Treatment of Breast Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01939054

Link

https://clinicaltrials.gov/show/NCT01939054

Palabras clave

Versiones (1)
  1. 24/9/19 24/9/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

24 de septiembre de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01939054

Inglés

Eligibility Breast Cancer NCT01939054

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histological and immunohistochemistry (ihc) confirmed recurrent or metastatic triple-negative breast cancer .
Descripción

Triple Negative Breast Neoplasm Recurrent Immunohistochemistry | Triple Negative Breast Neoplasm metastatic Immunohistochemistry

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3539878
UMLS CUI [1,2]
C2945760
UMLS CUI [1,3]
C0021044
UMLS CUI [2,1]
C3539878
UMLS CUI [2,2]
C1522484
UMLS CUI [2,3]
C0021044
2. previous chemotherapy should include anthracycline or taxane; no prior chemotherapy after metastasis.
Descripción

Prior Chemotherapy | Anthracyclines | taxane | Absence Prior Chemotherapy Post Neoplasm Metastasis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2]
C0282564
UMLS CUI [3]
C0215136
UMLS CUI [4,1]
C0332197
UMLS CUI [4,2]
C1514457
UMLS CUI [4,3]
C0687676
UMLS CUI [4,4]
C0027627
3. females with age between 18 and 70 years old
Descripción

Gender | Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
4. ecog performance status 0 or 1.
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
5. at least one measurable disease according to the response evaluation criteria in solid tumor (recist) by magnetic resonance imaging, or computed tomography; the target lesions is unresectable; the target lesions did not receive radiotherapy or relapse within the radiation field;
Descripción

Measurable Disease Quantity MRI | Measurable Disease Quantity CT | Target Lesion unresectable | Therapeutic radiology procedure Absent Target Lesion | Relapse Within Radiation Field

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0024485
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0040405
UMLS CUI [3,1]
C2986546
UMLS CUI [3,2]
C1519810
UMLS CUI [4,1]
C1522449
UMLS CUI [4,2]
C0332197
UMLS CUI [4,3]
C2986546
UMLS CUI [5,1]
C0035020
UMLS CUI [5,2]
C0332285
UMLS CUI [5,3]
C1882536
6. life expectancy ≥ 12 weeks.；
Descripción

Life Expectancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023671
7. wbc count ≥ 4 × 109 / l, neutrophils ≥ 1.5 × 109 / l, platelet count ≥ 100 × 109 / l, hemoglobin ≥ 6.21mmol / l (10 g / dl);
Descripción

White Blood Cell Count procedure | Neutrophil count | Platelet Count measurement | Hemoglobin measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0200633
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0518015
8. total bilirubin (tbl)≤ 1.5 x uln (upper limit of normal reference values); ast and alt ≤ 2.5 x uln or ≤ 5 uln (liver metastasis);serum creatinine ≤ 1.5 x uln.
Descripción

Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver | Creatinine measurement, serum

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0494165
UMLS CUI [5]
C0201976
9. before enrollment, patients have fully recovered from previous treatment-related toxicity;
Descripción

Toxicity Due to Prior Therapy | Patient recovered

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C1514463
UMLS CUI [2]
C1115804
10. subjects with fertility must accept effective contraceptive measures;
Descripción

Fertility Contraceptive methods

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0015895
UMLS CUI [1,2]
C0700589
11. signed informed consent
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. previously treatment regimen including anti egfr monoclonal antibody;
Descripción

Prior Therapy | Anti-EGFR Monoclonal Antibody

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2]
C4522190
2. receiving other anti-cancer medicine treatment during the study
Descripción

Pharmacotherapy Malignant Neoplasms

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0006826
3. participate in other clinical trials within 4 weeks in this group;
Descripción

Study Subject Participation Status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
4. accepted taxane treatment in 1 year;
Descripción

taxane

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0215136
5. presence of neurological symptoms due to brain metastasis, patients receiving steroidal anti-edema drugs therapy;
Descripción

Neurologic Symptoms Due to Metastatic malignant neoplasm to brain | Steroid therapy Edema

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0235031
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0220650
UMLS CUI [2,1]
C0149783
UMLS CUI [2,2]
C0013604
6. patients having a history of clinically significant symptomatic angina, arrhythmia or congestive heart failure without control;
Descripción

Angina Pectoris Symptomatic Uncontrolled | Cardiac Arrhythmia Uncontrolled | Congestive heart failure Uncontrolled

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0002962
UMLS CUI [1,2]
C0231220
UMLS CUI [1,3]
C0205318
UMLS CUI [2,1]
C0003811
UMLS CUI [2,2]
C0205318
UMLS CUI [3,1]
C0018802
UMLS CUI [3,2]
C0205318
7. diagnosed with severe interstitial pneumonitis or pulmonary fibrosis by chest ct;
Descripción

Interstitial Pneumonia Severe Chest CT | Pulmonary Fibrosis Severe Chest CT

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0206061
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0202823
UMLS CUI [2,1]
C0034069
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0202823
8. pleural effusion, ascites require to be drained;
Descripción

Pleural effusion disorder | Ascites Requirement Drainage

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032227
UMLS CUI [2,1]
C0003962
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0013103
9. adverse drug addiction and drug abuse, long-term alcoholics, as well as aids patients; patients with severe or uncontrolled complications, such as infection requiring systemic therapy, fever (≥ 38 ℃), diabetes or hypertension can not be controlled by medicine, other complications may interfere with drug therapy;
Descripción

Drug Dependence | Drug abuse | Alcoholics Long-term | AIDS | Complications Severe | Complications Uncontrolled | Communicable Disease Requirement Systemic therapy | Fever Uncontrolled | Diabetes Mellitus Uncontrolled | Hypertensive disease Uncontrolled | Complications Interfere with Pharmacotherapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1510472
UMLS CUI [2]
C0013146
UMLS CUI [3,1]
C0687725
UMLS CUI [3,2]
C0443252
UMLS CUI [4]
C0001175
UMLS CUI [5,1]
C0009566
UMLS CUI [5,2]
C0205082
UMLS CUI [6,1]
C0009566
UMLS CUI [6,2]
C0205318
UMLS CUI [7,1]
C0009450
UMLS CUI [7,2]
C1514873
UMLS CUI [7,3]
C1515119
UMLS CUI [8,1]
C0015967
UMLS CUI [8,2]
C0205318
UMLS CUI [9,1]
C0011849
UMLS CUI [9,2]
C0205318
UMLS CUI [10,1]
C0020538
UMLS CUI [10,2]
C0205318
UMLS CUI [11,1]
C0009566
UMLS CUI [11,2]
C0521102
UMLS CUI [11,3]
C0013216
10. patients with a history of drug allergy (≥ ctcae 2 level) such as shock or allergic symptoms, especially have allergic reactions to similar drugs in the past, have severe allergies reactions to drugs containing polysorbate eighty (tween 80);
Descripción

Drug Allergy CTCAE Grades | Shock | Allergic symptom | Allergic Reaction Pharmaceutical Preparations Similar | Severe allergy Pharmaceutical Preparations Containing Polysorbate 80 | Severe allergy Pharmaceutical Preparations Containing Tween 80

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013182
UMLS CUI [1,2]
C1516728
UMLS CUI [2]
C0036974
UMLS CUI [3]
C0740903
UMLS CUI [4,1]
C1527304
UMLS CUI [4,2]
C0013227
UMLS CUI [4,3]
C2348205
UMLS CUI [5,1]
C2945656
UMLS CUI [5,2]
C0013227
UMLS CUI [5,3]
C0332256
UMLS CUI [5,4]
C0032601
UMLS CUI [6,1]
C2945656
UMLS CUI [6,2]
C0013227
UMLS CUI [6,3]
C0332256
UMLS CUI [6,4]
C0041417
11. uncontrolled seizures or loss of insight due to mental disorders;
Descripción

Seizures Uncontrolled | Impaired insight Due to Mental disorders

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0036572
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0233823
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0004936
12. pregnant or lactating women；
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
13. researchers think improper for this trial
Descripción

Study Subject Participation Status Inappropriate

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548788
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Similar models

Eligibility Breast Cancer NCT01939054

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Triple Negative Breast Neoplasm Recurrent Immunohistochemistry | Triple Negative Breast Neoplasm metastatic Immunohistochemistry
Item
1. histological and immunohistochemistry (ihc) confirmed recurrent or metastatic triple-negative breast cancer .
boolean
C3539878 (UMLS CUI [1,1])
C2945760 (UMLS CUI [1,2])
C0021044 (UMLS CUI [1,3])
C3539878 (UMLS CUI [2,1])
C1522484 (UMLS CUI [2,2])
C0021044 (UMLS CUI [2,3])
Prior Chemotherapy | Anthracyclines | taxane | Absence Prior Chemotherapy Post Neoplasm Metastasis
Item
2. previous chemotherapy should include anthracycline or taxane; no prior chemotherapy after metastasis.
boolean
C1514457 (UMLS CUI [1])
C0282564 (UMLS CUI [2])
C0215136 (UMLS CUI [3])
C0332197 (UMLS CUI [4,1])
C1514457 (UMLS CUI [4,2])
C0687676 (UMLS CUI [4,3])
C0027627 (UMLS CUI [4,4])
Gender | Age
Item
3. females with age between 18 and 70 years old
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
ECOG performance status
Item
4. ecog performance status 0 or 1.
boolean
C1520224 (UMLS CUI [1])
Measurable Disease Quantity MRI | Measurable Disease Quantity CT | Target Lesion unresectable | Therapeutic radiology procedure Absent Target Lesion | Relapse Within Radiation Field
Item
5. at least one measurable disease according to the response evaluation criteria in solid tumor (recist) by magnetic resonance imaging, or computed tomography; the target lesions is unresectable; the target lesions did not receive radiotherapy or relapse within the radiation field;
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0024485 (UMLS CUI [1,3])
C1513041 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0040405 (UMLS CUI [2,3])
C2986546 (UMLS CUI [3,1])
C1519810 (UMLS CUI [3,2])
C1522449 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C2986546 (UMLS CUI [4,3])
C0035020 (UMLS CUI [5,1])
C0332285 (UMLS CUI [5,2])
C1882536 (UMLS CUI [5,3])
Life Expectancy
Item
6. life expectancy ≥ 12 weeks.；
boolean
C0023671 (UMLS CUI [1])
White Blood Cell Count procedure | Neutrophil count | Platelet Count measurement | Hemoglobin measurement
Item
7. wbc count ≥ 4 × 109 / l, neutrophils ≥ 1.5 × 109 / l, platelet count ≥ 100 × 109 / l, hemoglobin ≥ 6.21mmol / l (10 g / dl);
boolean
C0023508 (UMLS CUI [1])
C0200633 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver | Creatinine measurement, serum
Item
8. total bilirubin (tbl)≤ 1.5 x uln (upper limit of normal reference values); ast and alt ≤ 2.5 x uln or ≤ 5 uln (liver metastasis);serum creatinine ≤ 1.5 x uln.
boolean
C1278039 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0494165 (UMLS CUI [4])
C0201976 (UMLS CUI [5])
Toxicity Due to Prior Therapy | Patient recovered
Item
9. before enrollment, patients have fully recovered from previous treatment-related toxicity;
boolean
C0600688 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C1514463 (UMLS CUI [1,3])
C1115804 (UMLS CUI [2])
Fertility Contraceptive methods
Item
10. subjects with fertility must accept effective contraceptive measures;
boolean
C0015895 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Informed Consent
Item
11. signed informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Prior Therapy | Anti-EGFR Monoclonal Antibody
Item
1. previously treatment regimen including anti egfr monoclonal antibody;
boolean
C1514463 (UMLS CUI [1])
C4522190 (UMLS CUI [2])
Pharmacotherapy Malignant Neoplasms
Item
2. receiving other anti-cancer medicine treatment during the study
boolean
C0013216 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
Study Subject Participation Status
Item
3. participate in other clinical trials within 4 weeks in this group;
boolean
C2348568 (UMLS CUI [1])
taxane
Item
4. accepted taxane treatment in 1 year;
boolean
C0215136 (UMLS CUI [1])
Neurologic Symptoms Due to Metastatic malignant neoplasm to brain | Steroid therapy Edema
Item
5. presence of neurological symptoms due to brain metastasis, patients receiving steroidal anti-edema drugs therapy;
boolean
C0235031 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0220650 (UMLS CUI [1,3])
C0149783 (UMLS CUI [2,1])
C0013604 (UMLS CUI [2,2])
Angina Pectoris Symptomatic Uncontrolled | Cardiac Arrhythmia Uncontrolled | Congestive heart failure Uncontrolled
Item
6. patients having a history of clinically significant symptomatic angina, arrhythmia or congestive heart failure without control;
boolean
C0002962 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C0003811 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0018802 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
Interstitial Pneumonia Severe Chest CT | Pulmonary Fibrosis Severe Chest CT
Item
7. diagnosed with severe interstitial pneumonitis or pulmonary fibrosis by chest ct;
boolean
C0206061 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0202823 (UMLS CUI [1,3])
C0034069 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0202823 (UMLS CUI [2,3])
Pleural effusion disorder | Ascites Requirement Drainage
Item
8. pleural effusion, ascites require to be drained;
boolean
C0032227 (UMLS CUI [1])
C0003962 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0013103 (UMLS CUI [2,3])
Drug Dependence | Drug abuse | Alcoholics Long-term | AIDS | Complications Severe | Complications Uncontrolled | Communicable Disease Requirement Systemic therapy | Fever Uncontrolled | Diabetes Mellitus Uncontrolled | Hypertensive disease Uncontrolled | Complications Interfere with Pharmacotherapy
Item
9. adverse drug addiction and drug abuse, long-term alcoholics, as well as aids patients; patients with severe or uncontrolled complications, such as infection requiring systemic therapy, fever (≥ 38 ℃), diabetes or hypertension can not be controlled by medicine, other complications may interfere with drug therapy;
boolean
C1510472 (UMLS CUI [1])
C0013146 (UMLS CUI [2])
C0687725 (UMLS CUI [3,1])
C0443252 (UMLS CUI [3,2])
C0001175 (UMLS CUI [4])
C0009566 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C0009566 (UMLS CUI [6,1])
C0205318 (UMLS CUI [6,2])
C0009450 (UMLS CUI [7,1])
C1514873 (UMLS CUI [7,2])
C1515119 (UMLS CUI [7,3])
C0015967 (UMLS CUI [8,1])
C0205318 (UMLS CUI [8,2])
C0011849 (UMLS CUI [9,1])
C0205318 (UMLS CUI [9,2])
C0020538 (UMLS CUI [10,1])
C0205318 (UMLS CUI [10,2])
C0009566 (UMLS CUI [11,1])
C0521102 (UMLS CUI [11,2])
C0013216 (UMLS CUI [11,3])
Drug Allergy CTCAE Grades | Shock | Allergic symptom | Allergic Reaction Pharmaceutical Preparations Similar | Severe allergy Pharmaceutical Preparations Containing Polysorbate 80 | Severe allergy Pharmaceutical Preparations Containing Tween 80
Item
10. patients with a history of drug allergy (≥ ctcae 2 level) such as shock or allergic symptoms, especially have allergic reactions to similar drugs in the past, have severe allergies reactions to drugs containing polysorbate eighty (tween 80);
boolean
C0013182 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C0036974 (UMLS CUI [2])
C0740903 (UMLS CUI [3])
C1527304 (UMLS CUI [4,1])
C0013227 (UMLS CUI [4,2])
C2348205 (UMLS CUI [4,3])
C2945656 (UMLS CUI [5,1])
C0013227 (UMLS CUI [5,2])
C0332256 (UMLS CUI [5,3])
C0032601 (UMLS CUI [5,4])
C2945656 (UMLS CUI [6,1])
C0013227 (UMLS CUI [6,2])
C0332256 (UMLS CUI [6,3])
C0041417 (UMLS CUI [6,4])
Seizures Uncontrolled | Impaired insight Due to Mental disorders
Item
11. uncontrolled seizures or loss of insight due to mental disorders;
boolean
C0036572 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0233823 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0004936 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
12. pregnant or lactating women；
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Study Subject Participation Status Inappropriate
Item
13. researchers think improper for this trial
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
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