ID

38064

Beschreibung

Safety Study of Enzalutamide (MDV3100) in Patients With Incurable Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01597193

Link

https://clinicaltrials.gov/show/NCT01597193

Stichworte

Versionen (1)
  1. 14.09.19 14.09.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

14. September 2019

DOI

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Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01597193

Englisch

Eligibility Breast Cancer NCT01597193

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed breast cancer with accompanying pathology report;
Beschreibung

Breast Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0678222
submit unstained representative tumor specimen, either as a paraffin block (preferred) or ≥ 10 unstained slides
Beschreibung

Tumor tissue sample Unstained Paraffin Block | Tumor tissue sample Unstained Slide Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C1883469
UMLS CUI [1,3]
C1519524
UMLS CUI [2,1]
C0475358
UMLS CUI [2,2]
C1883469
UMLS CUI [2,3]
C1265611
received at least 2 lines of systemic therapy in the advanced setting (for enzalutamide alone arm only);
Beschreibung

Systemic therapy Quantity Advanced disease | Enzalutamide Protocol Arm

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0679246
UMLS CUI [2,1]
C3496793
UMLS CUI [2,2]
C1522541
eastern cooperative oncology group performance (ecog) status of 0 or 1;
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
estimated life expectancy of at least 3 months
Beschreibung

Life Expectancy Estimated

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023671
UMLS CUI [1,2]
C0750572
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
severe concurrent disease, infection, or comorbidity that, in the judgment of the investigator, would make the patient inappropriate for enrollment;
Beschreibung

Comorbidity Severe | Communicable Disease Severe | Study Subject Participation Status Inappropriate

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C2348568
UMLS CUI [3,2]
C1548788
pregnant or lactating;
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
known or suspected brain metastasis or leptomeningeal disease;
Beschreibung

Metastatic malignant neoplasm to brain | Metastatic malignant neoplasm to brain Suspected | Leptomeningeal Neoplasm | Leptomeningeal Neoplasm Suspected

Datentyp

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2,1]
C0220650
UMLS CUI [2,2]
C0750491
UMLS CUI [3]
C0751297
UMLS CUI [4,1]
C0751297
UMLS CUI [4,2]
C0750491
history of another malignancy within the previous 5 years other than curatively treated in situ carcinomas;
Beschreibung

Cancer Other | Exception Curative treatment Carcinoma in Situ

Datentyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1273390
UMLS CUI [2,3]
C0007099
for patients who are enrolled to receive enzalutamide plus anastrozole or exemestane or fulvestrant must not have received tamoxifen or any medication known to be a potent cyp3a4 inducer or inhibitor.
Beschreibung

Enrollment | Enzalutamide Plus Anastrozole | exemestane | fulvestrant | Tamoxifen Absent | CYP3A4 Inducers Strong Absent | CYP3A4 Inhibitors Strong Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C1516879
UMLS CUI [2,1]
C3496793
UMLS CUI [2,2]
C0332287
UMLS CUI [2,3]
C0290883
UMLS CUI [3]
C0851344
UMLS CUI [4]
C0935916
UMLS CUI [5,1]
C0039286
UMLS CUI [5,2]
C0332197
UMLS CUI [6,1]
C3850041
UMLS CUI [6,2]
C0442821
UMLS CUI [6,3]
C0332197
UMLS CUI [7,1]
C3850053
UMLS CUI [7,2]
C0442821
UMLS CUI [7,3]
C0332197
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Ähnliche Modelle

Eligibility Breast Cancer NCT01597193

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma
Item
histologically confirmed breast cancer with accompanying pathology report;
boolean
C0678222 (UMLS CUI [1])
Tumor tissue sample Unstained Paraffin Block | Tumor tissue sample Unstained Slide Quantity
Item
submit unstained representative tumor specimen, either as a paraffin block (preferred) or ≥ 10 unstained slides
boolean
C0475358 (UMLS CUI [1,1])
C1883469 (UMLS CUI [1,2])
C1519524 (UMLS CUI [1,3])
C0475358 (UMLS CUI [2,1])
C1883469 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Systemic therapy Quantity Advanced disease | Enzalutamide Protocol Arm
Item
received at least 2 lines of systemic therapy in the advanced setting (for enzalutamide alone arm only);
boolean
C1515119 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0679246 (UMLS CUI [1,3])
C3496793 (UMLS CUI [2,1])
C1522541 (UMLS CUI [2,2])
ECOG performance status
Item
eastern cooperative oncology group performance (ecog) status of 0 or 1;
boolean
C1520224 (UMLS CUI [1])
Life Expectancy Estimated
Item
estimated life expectancy of at least 3 months
boolean
C0023671 (UMLS CUI [1,1])
C0750572 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Comorbidity Severe | Communicable Disease Severe | Study Subject Participation Status Inappropriate
Item
severe concurrent disease, infection, or comorbidity that, in the judgment of the investigator, would make the patient inappropriate for enrollment;
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C2348568 (UMLS CUI [3,1])
C1548788 (UMLS CUI [3,2])
Pregnancy | Breast Feeding
Item
pregnant or lactating;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Metastatic malignant neoplasm to brain | Metastatic malignant neoplasm to brain Suspected | Leptomeningeal Neoplasm | Leptomeningeal Neoplasm Suspected
Item
known or suspected brain metastasis or leptomeningeal disease;
boolean
C0220650 (UMLS CUI [1])
C0220650 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0751297 (UMLS CUI [3])
C0751297 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
Cancer Other | Exception Curative treatment Carcinoma in Situ
Item
history of another malignancy within the previous 5 years other than curatively treated in situ carcinomas;
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1273390 (UMLS CUI [2,2])
C0007099 (UMLS CUI [2,3])
Enrollment | Enzalutamide Plus Anastrozole | exemestane | fulvestrant | Tamoxifen Absent | CYP3A4 Inducers Strong Absent | CYP3A4 Inhibitors Strong Absent
Item
for patients who are enrolled to receive enzalutamide plus anastrozole or exemestane or fulvestrant must not have received tamoxifen or any medication known to be a potent cyp3a4 inducer or inhibitor.
boolean
C1516879 (UMLS CUI [1])
C3496793 (UMLS CUI [2,1])
C0332287 (UMLS CUI [2,2])
C0290883 (UMLS CUI [2,3])
C0851344 (UMLS CUI [3])
C0935916 (UMLS CUI [4])
C0039286 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C3850041 (UMLS CUI [6,1])
C0442821 (UMLS CUI [6,2])
C0332197 (UMLS CUI [6,3])
C3850053 (UMLS CUI [7,1])
C0442821 (UMLS CUI [7,2])
C0332197 (UMLS CUI [7,3])
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