ID

23491

Beschrijving

Platinum for Triple-Negative Metastatic Breast Cancer and Evaluation of p63/p73 as a Biomarker of Response; ODM derived from: https://clinicaltrials.gov/show/NCT00483223

Link

https://clinicaltrials.gov/show/NCT00483223

Trefwoorden

Versies (1)
  1. 08-07-17 08-07-17 -
Geüploaded op

8 juli 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00483223

Engels

Eligibility Breast Cancer NCT00483223

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed invasive breast cancer with stage iv disease, according to ajcc 6th edition, either biopsy proven or with unequivocal evidence of metastatic disease by physical examination or radiological study
Beschrijving

Invasive carcinoma of breast | Disease TNM clinical staging | Neoplasm Metastasis Physical Examination | Neoplasm Metastasis Radiology studies

Datatype

boolean

Alias
UMLS CUI [1]
C0853879
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C3258246
UMLS CUI [3,1]
C0027627
UMLS CUI [3,2]
C0031809
UMLS CUI [4,1]
C0027627
UMLS CUI [4,2]
C0807679
all tumors must be er-, pgr- and her2-negative
Beschrijving

Triple-Negative Breast Cancer

Datatype

boolean

Alias
UMLS CUI [1]
C2348819
18 years of age or older
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
paraffin tissue block is required from the primary tumor tissue or from diagnostic metastatic biopsy at time of relapse
Beschrijving

Paraffin Embedded Tissue Primary tumor Requirement | Paraffin Embedded Tissue Biopsy Neoplasm Metastasis | Timepoint Relapse

Datatype

boolean

Alias
UMLS CUI [1,1]
C1519524
UMLS CUI [1,2]
C0677930
UMLS CUI [1,3]
C1514873
UMLS CUI [2,1]
C1519524
UMLS CUI [2,2]
C0005558
UMLS CUI [2,3]
C0027627
UMLS CUI [3,1]
C2348792
UMLS CUI [3,2]
C0035020
measurable disease by recist
Beschrijving

Measurable Disease

Datatype

boolean

Alias
UMLS CUI [1]
C1513041
performance status of 0,1 or 2 by ecog criteria
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy greater than 12 weeks
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
normal organ and bone marrow function documented within 14 days prior to enrollment as defined by the protocol
Beschrijving

Organ function | Bone Marrow function

Datatype

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
more than 1 prior chemotherapy for the treatment of recurrent or metastatic breast cancer
Beschrijving

Chemotherapy Quantity Breast cancer recurrent | Chemotherapy Quantity Secondary malignant neoplasm of female breast

Datatype

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0278493
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0346993
prior treatment with cisplatin, carboplatin, or other platinum chemotherapy agents
Beschrijving

Cisplatin | Carboplatin | Chemotherapeutic Agents Platinum

Datatype

boolean

Alias
UMLS CUI [1]
C0008838
UMLS CUI [2]
C0079083
UMLS CUI [3,1]
C0003392
UMLS CUI [3,2]
C0032207
active brain metastases or unevaluated neurological symptoms suggestive of brain metastases
Beschrijving

Metastatic malignant neoplasm to brain | Neurologic Symptoms Suggestive of Metastatic malignant neoplasm to brain

Datatype

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2,1]
C0235031
UMLS CUI [2,2]
C0332299
UMLS CUI [2,3]
C0220650
intercurrent illness or other major medical condition or comorbid condition that might affect study participation
Beschrijving

Comorbidity Affecting Study Subject Participation Status | Other medical condition Major Affecting Study Subject Participation Status

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0205164
UMLS CUI [2,3]
C0392760
UMLS CUI [2,4]
C2348568
significant history of uncontrolled cardiac disease such as uncontrolled hypertension, unstable angina, recent myocardial infarction, uncontrolled congestive heart failure, cardiomyopathy either symptomatic or asymptomatic but with decreased ejection fraction <45%
Beschrijving

Heart Disease Uncontrolled | Uncontrolled hypertension | Angina, Unstable | Myocardial Infarction | Congestive heart failure Uncontrolled | Cardiomyopathy Symptomatic | Cardiomyopathy Asymptomatic | Ejection fraction decreased

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C1868885
UMLS CUI [3]
C0002965
UMLS CUI [4]
C0027051
UMLS CUI [5,1]
C0018802
UMLS CUI [5,2]
C0205318
UMLS CUI [6,1]
C0878544
UMLS CUI [6,2]
C0231220
UMLS CUI [7,1]
C0878544
UMLS CUI [7,2]
C0231221
UMLS CUI [8]
C0743400
renal dysfunction for which cisplatin dose would either require dose modification or would be considered unsafe
Beschrijving

Renal dysfunction | Cisplatin Requirement Dose Modification | Cisplatin Dose Uncertain

Datatype

boolean

Alias
UMLS CUI [1]
C3279454
UMLS CUI [2,1]
C0008838
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0178602
UMLS CUI [2,4]
C0392747
UMLS CUI [3,1]
C0008838
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0087130
pregnant or nursing women
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
history or other malignancy that was not treated with curative intent
Beschrijving

Malignant Neoplasms Curative treatment Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C1273390
UMLS CUI [1,3]
C0332197
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Similar models

Eligibility Breast Cancer NCT00483223

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Invasive carcinoma of breast | Disease TNM clinical staging | Neoplasm Metastasis Physical Examination | Neoplasm Metastasis Radiology studies
Item
histologically confirmed invasive breast cancer with stage iv disease, according to ajcc 6th edition, either biopsy proven or with unequivocal evidence of metastatic disease by physical examination or radiological study
boolean
C0853879 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
C0027627 (UMLS CUI [3,1])
C0031809 (UMLS CUI [3,2])
C0027627 (UMLS CUI [4,1])
C0807679 (UMLS CUI [4,2])
Triple-Negative Breast Cancer
Item
all tumors must be er-, pgr- and her2-negative
boolean
C2348819 (UMLS CUI [1])
Age
Item
18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Paraffin Embedded Tissue Primary tumor Requirement | Paraffin Embedded Tissue Biopsy Neoplasm Metastasis | Timepoint Relapse
Item
paraffin tissue block is required from the primary tumor tissue or from diagnostic metastatic biopsy at time of relapse
boolean
C1519524 (UMLS CUI [1,1])
C0677930 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
C1519524 (UMLS CUI [2,1])
C0005558 (UMLS CUI [2,2])
C0027627 (UMLS CUI [2,3])
C2348792 (UMLS CUI [3,1])
C0035020 (UMLS CUI [3,2])
Measurable Disease
Item
measurable disease by recist
boolean
C1513041 (UMLS CUI [1])
ECOG performance status
Item
performance status of 0,1 or 2 by ecog criteria
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy greater than 12 weeks
boolean
C0023671 (UMLS CUI [1])
Organ function | Bone Marrow function
Item
normal organ and bone marrow function documented within 14 days prior to enrollment as defined by the protocol
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Chemotherapy Quantity Breast cancer recurrent | Chemotherapy Quantity Secondary malignant neoplasm of female breast
Item
more than 1 prior chemotherapy for the treatment of recurrent or metastatic breast cancer
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0278493 (UMLS CUI [1,3])
C0392920 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0346993 (UMLS CUI [2,3])
Cisplatin | Carboplatin | Chemotherapeutic Agents Platinum
Item
prior treatment with cisplatin, carboplatin, or other platinum chemotherapy agents
boolean
C0008838 (UMLS CUI [1])
C0079083 (UMLS CUI [2])
C0003392 (UMLS CUI [3,1])
C0032207 (UMLS CUI [3,2])
Metastatic malignant neoplasm to brain | Neurologic Symptoms Suggestive of Metastatic malignant neoplasm to brain
Item
active brain metastases or unevaluated neurological symptoms suggestive of brain metastases
boolean
C0220650 (UMLS CUI [1])
C0235031 (UMLS CUI [2,1])
C0332299 (UMLS CUI [2,2])
C0220650 (UMLS CUI [2,3])
Comorbidity Affecting Study Subject Participation Status | Other medical condition Major Affecting Study Subject Participation Status
Item
intercurrent illness or other major medical condition or comorbid condition that might affect study participation
boolean
C0009488 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0205164 (UMLS CUI [2,2])
C0392760 (UMLS CUI [2,3])
C2348568 (UMLS CUI [2,4])
Heart Disease Uncontrolled | Uncontrolled hypertension | Angina, Unstable | Myocardial Infarction | Congestive heart failure Uncontrolled | Cardiomyopathy Symptomatic | Cardiomyopathy Asymptomatic | Ejection fraction decreased
Item
significant history of uncontrolled cardiac disease such as uncontrolled hypertension, unstable angina, recent myocardial infarction, uncontrolled congestive heart failure, cardiomyopathy either symptomatic or asymptomatic but with decreased ejection fraction <45%
boolean
C0018799 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C1868885 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
C0018802 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
C0878544 (UMLS CUI [6,1])
C0231220 (UMLS CUI [6,2])
C0878544 (UMLS CUI [7,1])
C0231221 (UMLS CUI [7,2])
C0743400 (UMLS CUI [8])
Renal dysfunction | Cisplatin Requirement Dose Modification | Cisplatin Dose Uncertain
Item
renal dysfunction for which cisplatin dose would either require dose modification or would be considered unsafe
boolean
C3279454 (UMLS CUI [1])
C0008838 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C0392747 (UMLS CUI [2,4])
C0008838 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0087130 (UMLS CUI [3,3])
Pregnancy | Breast Feeding
Item
pregnant or nursing women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Malignant Neoplasms Curative treatment Absent
Item
history or other malignancy that was not treated with curative intent
boolean
C0006826 (UMLS CUI [1,1])
C1273390 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
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