ID

34985

Description

A Study to Assess the Safety and Efficacy of the VEGFR-FGFR Inhibitor, Lucitanib, Given to Patients With FGF Aberrant Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02202746

Link

https://clinicaltrials.gov/show/NCT02202746

Keywords

Versions (1)
  1. 2/6/19 2/6/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 6, 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 NCT02202746

English

Eligibility Breast Cancer NCT02202746

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed metastatic breast cancer relapsed or refractory to approved standard available treatment
Description

BREAST CANCER METASTATIC RECURRENT | Secondary malignant neoplasm of female breast Unresponsive to Standard therapy

Data type

boolean

Alias
UMLS CUI [1]
C0741681
UMLS CUI [2,1]
C0346993
UMLS CUI [2,2]
C0205269
UMLS CUI [2,3]
C2936643
prior treatment with standard first line therapy in the metastatic setting
Description

First line treatment Standard Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1,1]
C1708063
UMLS CUI [1,2]
C1442989
UMLS CUI [1,3]
C0027627
availability of tumor tissue sufficient for confirmatory testing of fgfr1 and 11q amplification status
Description

Availability of Tumor tissue sample | FGFR1 Gene Amplification Testing | 11q Amplification Testing

Data type

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C0475358
UMLS CUI [2,1]
C1517090
UMLS CUI [2,2]
C0039593
UMLS CUI [3,1]
C0796366
UMLS CUI [3,2]
C1521871
UMLS CUI [3,3]
C0039593
demonstrated progression of disease by radiological or clinical assessment (measurable disease according to recist version 1.1 is not required for enrollment)
Description

Disease Progression | Measurable Disease

Data type

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2]
C1513041
estimated life expectancy >6 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
current or recent treatment with biologic anticancer therapies
Description

Cancer treatment biological

Data type

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205460
ongoing aes from prior anticancer therapies
Description

Adverse events Due to Cancer treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0920425
active central nervous system (cns) metastases
Description

CNS metastases

Data type

boolean

Alias
UMLS CUI [1]
C0686377
clinically significant or uncontrolled hypertension or cardiac disease
Description

Hypertensive disease Clinical Significance | Uncontrolled hypertension | Heart Disease Clinical Significance | Heart Disease Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C2826293
UMLS CUI [2]
C1868885
UMLS CUI [3,1]
C0018799
UMLS CUI [3,2]
C2826293
UMLS CUI [4,1]
C0018799
UMLS CUI [4,2]
C0205318
females who are pregnant or breastfeeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
for cohort c (biomarker-negative) patients: greater than 3 lines of previous chemotherapy in the metastatic setting
Description

Chemotherapy Quantity Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0027627
Back to the top of the page

Similar models

Eligibility Breast Cancer NCT02202746

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
BREAST CANCER METASTATIC RECURRENT | Secondary malignant neoplasm of female breast Unresponsive to Standard therapy
Item
histologically or cytologically confirmed metastatic breast cancer relapsed or refractory to approved standard available treatment
boolean
C0741681 (UMLS CUI [1])
C0346993 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
C2936643 (UMLS CUI [2,3])
First line treatment Standard Neoplasm Metastasis
Item
prior treatment with standard first line therapy in the metastatic setting
boolean
C1708063 (UMLS CUI [1,1])
C1442989 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
Availability of Tumor tissue sample | FGFR1 Gene Amplification Testing | 11q Amplification Testing
Item
availability of tumor tissue sufficient for confirmatory testing of fgfr1 and 11q amplification status
boolean
C0470187 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
C1517090 (UMLS CUI [2,1])
C0039593 (UMLS CUI [2,2])
C0796366 (UMLS CUI [3,1])
C1521871 (UMLS CUI [3,2])
C0039593 (UMLS CUI [3,3])
Disease Progression | Measurable Disease
Item
demonstrated progression of disease by radiological or clinical assessment (measurable disease according to recist version 1.1 is not required for enrollment)
boolean
C0242656 (UMLS CUI [1])
C1513041 (UMLS CUI [2])
Life Expectancy
Item
estimated life expectancy >6 months
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cancer treatment biological
Item
current or recent treatment with biologic anticancer therapies
boolean
C0920425 (UMLS CUI [1,1])
C0205460 (UMLS CUI [1,2])
Adverse events Due to Cancer treatment
Item
ongoing aes from prior anticancer therapies
boolean
C0877248 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0920425 (UMLS CUI [1,3])
CNS metastases
Item
active central nervous system (cns) metastases
boolean
C0686377 (UMLS CUI [1])
Hypertensive disease Clinical Significance | Uncontrolled hypertension | Heart Disease Clinical Significance | Heart Disease Uncontrolled
Item
clinically significant or uncontrolled hypertension or cardiac disease
boolean
C0020538 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C1868885 (UMLS CUI [2])
C0018799 (UMLS CUI [3,1])
C2826293 (UMLS CUI [3,2])
C0018799 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
Pregnancy | Breast Feeding
Item
females who are pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Chemotherapy Quantity Neoplasm Metastasis
Item
for cohort c (biomarker-negative) patients: greater than 3 lines of previous chemotherapy in the metastatic setting
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
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