ID

38064

Description

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

Keywords

Versions (1)
  1. 9/14/19 9/14/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 14, 2019

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Breast Cancer NCT01597193

English

Eligibility Breast Cancer NCT01597193

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Breast Carcinoma

Data type

boolean

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

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

Data type

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);
Description

Systemic therapy Quantity Advanced disease | Enzalutamide Protocol Arm

Data type

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;
Description

ECOG performance status

Data type

boolean

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

Life Expectancy Estimated

Data type

boolean

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

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;
Description

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

Data type

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;
Description

Pregnancy | Breast Feeding

Data type

boolean

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

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

Data type

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;
Description

Cancer Other | Exception Curative treatment Carcinoma in Situ

Data type

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.
Description

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

Data type

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
Back to the top of the page

Similar models

Eligibility Breast Cancer NCT01597193

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial