ID

30552

Beschrijving

Topical Imiquimod and Abraxane in Treating Patients With Advanced Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00821964

Link

https://clinicaltrials.gov/show/NCT00821964

Trefwoorden

Versies (1)
  1. 2018-06-13 2018-06-13 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

13 juni 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Male Breast Cancer NCT00821964

Engels

Eligibility Male Breast Cancer NCT00821964

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with advanced stage refractory breast cancer
Beschrijving

Advanced breast cancer refractory

Datatype

boolean

Alias
UMLS CUI [1,1]
C3495917
UMLS CUI [1,2]
C0205269
progressive or relapsed disease following standard therapy with chemotherapy and/or surgery, and/or radiation
Beschrijving

Progressive Disease Post Standard of Care | Recurrent disease Post Standard of Care | Chemotherapy | Operative Surgical Procedures | Therapeutic radiology procedure

Datatype

boolean

Alias
UMLS CUI [1,1]
C1335499
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C2936643
UMLS CUI [2,1]
C0277556
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C2936643
UMLS CUI [3]
C0392920
UMLS CUI [4]
C0543467
UMLS CUI [5]
C1522449
patients must have measurable (bi-dimensional) chest wall disease and/or cutaneous metastatic lesions
Beschrijving

Measurable Disease 2-Dimensional Chest wall | Metastatic Lesion Cutaneous

Datatype

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1705052
UMLS CUI [1,3]
C0205076
UMLS CUI [2,1]
C1513183
UMLS CUI [2,2]
C0221912
patients must be at least 7 days from last chemotherapy and 30 days from local radiotherapy and/or systemic steroids
Beschrijving

Chemotherapy Discontinued | Therapeutic radiology procedure Local Discontinued | Systemic steroids Discontinued

Datatype

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1444662
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0205276
UMLS CUI [2,3]
C1444662
UMLS CUI [3,1]
C2825233
UMLS CUI [3,2]
C1444662
patients on bisphosphonates, trastuzumab, lapatinib and/or hormonal therapy are eligible
Beschrijving

Diphosphonates | Trastuzumab | Lapatinib | Hormone Therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0012544
UMLS CUI [2]
C0728747
UMLS CUI [3]
C1506770
UMLS CUI [4]
C0279025
white blood cell count >= 1000/ul
Beschrijving

White Blood Cell Count procedure

Datatype

boolean

Alias
UMLS CUI [1]
C0023508
absolute neutrophil count (anc) >= 1200/ul
Beschrijving

Absolute neutrophil count

Datatype

boolean

Alias
UMLS CUI [1]
C0948762
platelets > 75,000/ul
Beschrijving

Platelet Count measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0032181
serum creatinine =< 2.0 mg/dl, a creatinine clearance > 60 ml/min
Beschrijving

Creatinine measurement, serum | Creatinine clearance measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0373595
alanine aminotransferase (alt) and aspartate aminotransferase (ast) < 2 x upper limit normal (uln)
Beschrijving

Alanine aminotransferase measurement | Aspartate aminotransferase measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
total bilirubin < 2 x uln
Beschrijving

Serum total bilirubin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C1278039
patients must have a performance status score (eastern cooperative oncology group [ecog] scale) =< 2
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
patients must have recovered from major infections and/or surgical procedures and, in the opinion of the investigator, not have a significant active concurrent medical illness precluding protocol treatment
Beschrijving

Communicable Disease Major | Major surgery | Patient recovered | Absence Comorbidity Preventing Investigational Therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205164
UMLS CUI [2]
C0679637
UMLS CUI [3]
C1115804
UMLS CUI [4,1]
C0332197
UMLS CUI [4,2]
C0009488
UMLS CUI [4,3]
C1292733
UMLS CUI [4,4]
C0949266
men and women of reproductive ability must agree to contraceptive use during the study and for 1 month after imiquimod/abraxane treatment is discontinued
Beschrijving

Females & males of reproductive potential Contraceptive methods | Imiquimod Discontinued | Abraxane Discontinued

Datatype

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0165032
UMLS CUI [2,2]
C1444662
UMLS CUI [3,1]
C1564985
UMLS CUI [3,2]
C1444662
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with prior allergic reaction to taxanes
Beschrijving

Allergic Reaction Taxanes

Datatype

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0796419
patients with any clinically significant active autoimmune disease requiring active treatment with systemic steroids or other immunomodulators
Beschrijving

Autoimmune Disease Requirement Systemic steroids | Autoimmune Disease Requirement Immunomodulators

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004364
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C2825233
UMLS CUI [2,1]
C0004364
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C1527392
pregnant or breast-feeding women
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients with peripheral neuropathy >= grade 2
Beschrijving

Peripheral Neuropathy CTCAE Grades

Datatype

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
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Similar models

Eligibility Male Breast Cancer NCT00821964

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Advanced breast cancer refractory
Item
patients with advanced stage refractory breast cancer
boolean
C3495917 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
Progressive Disease Post Standard of Care | Recurrent disease Post Standard of Care | Chemotherapy | Operative Surgical Procedures | Therapeutic radiology procedure
Item
progressive or relapsed disease following standard therapy with chemotherapy and/or surgery, and/or radiation
boolean
C1335499 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C2936643 (UMLS CUI [1,3])
C0277556 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C2936643 (UMLS CUI [2,3])
C0392920 (UMLS CUI [3])
C0543467 (UMLS CUI [4])
C1522449 (UMLS CUI [5])
Measurable Disease 2-Dimensional Chest wall | Metastatic Lesion Cutaneous
Item
patients must have measurable (bi-dimensional) chest wall disease and/or cutaneous metastatic lesions
boolean
C1513041 (UMLS CUI [1,1])
C1705052 (UMLS CUI [1,2])
C0205076 (UMLS CUI [1,3])
C1513183 (UMLS CUI [2,1])
C0221912 (UMLS CUI [2,2])
Chemotherapy Discontinued | Therapeutic radiology procedure Local Discontinued | Systemic steroids Discontinued
Item
patients must be at least 7 days from last chemotherapy and 30 days from local radiotherapy and/or systemic steroids
boolean
C0392920 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0205276 (UMLS CUI [2,2])
C1444662 (UMLS CUI [2,3])
C2825233 (UMLS CUI [3,1])
C1444662 (UMLS CUI [3,2])
Diphosphonates | Trastuzumab | Lapatinib | Hormone Therapy
Item
patients on bisphosphonates, trastuzumab, lapatinib and/or hormonal therapy are eligible
boolean
C0012544 (UMLS CUI [1])
C0728747 (UMLS CUI [2])
C1506770 (UMLS CUI [3])
C0279025 (UMLS CUI [4])
White Blood Cell Count procedure
Item
white blood cell count >= 1000/ul
boolean
C0023508 (UMLS CUI [1])
Absolute neutrophil count
Item
absolute neutrophil count (anc) >= 1200/ul
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelets > 75,000/ul
boolean
C0032181 (UMLS CUI [1])
Creatinine measurement, serum | Creatinine clearance measurement
Item
serum creatinine =< 2.0 mg/dl, a creatinine clearance > 60 ml/min
boolean
C0201976 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Alanine aminotransferase measurement | Aspartate aminotransferase measurement
Item
alanine aminotransferase (alt) and aspartate aminotransferase (ast) < 2 x upper limit normal (uln)
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
Serum total bilirubin measurement
Item
total bilirubin < 2 x uln
boolean
C1278039 (UMLS CUI [1])
ECOG performance status
Item
patients must have a performance status score (eastern cooperative oncology group [ecog] scale) =< 2
boolean
C1520224 (UMLS CUI [1])
Communicable Disease Major | Major surgery | Patient recovered | Absence Comorbidity Preventing Investigational Therapy
Item
patients must have recovered from major infections and/or surgical procedures and, in the opinion of the investigator, not have a significant active concurrent medical illness precluding protocol treatment
boolean
C0009450 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0679637 (UMLS CUI [2])
C1115804 (UMLS CUI [3])
C0332197 (UMLS CUI [4,1])
C0009488 (UMLS CUI [4,2])
C1292733 (UMLS CUI [4,3])
C0949266 (UMLS CUI [4,4])
Females & males of reproductive potential Contraceptive methods | Imiquimod Discontinued | Abraxane Discontinued
Item
men and women of reproductive ability must agree to contraceptive use during the study and for 1 month after imiquimod/abraxane treatment is discontinued
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0165032 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C1564985 (UMLS CUI [3,1])
C1444662 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Allergic Reaction Taxanes
Item
patients with prior allergic reaction to taxanes
boolean
C1527304 (UMLS CUI [1,1])
C0796419 (UMLS CUI [1,2])
Autoimmune Disease Requirement Systemic steroids | Autoimmune Disease Requirement Immunomodulators
Item
patients with any clinically significant active autoimmune disease requiring active treatment with systemic steroids or other immunomodulators
boolean
C0004364 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C2825233 (UMLS CUI [1,3])
C0004364 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C1527392 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Peripheral Neuropathy CTCAE Grades
Item
patients with peripheral neuropathy >= grade 2
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
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