ID

38022

Description

Study of GDC-0941 or GDC-0980 With Fulvestrant Versus Fulvestrant in Advanced or Metastatic Breast Cancer in Patients Resistant to Aromatase Inhibitor Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT01437566

Link

https://clinicaltrials.gov/show/NCT01437566

Keywords

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

See clinicaltrials.gov

Uploaded on

September 9, 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 NCT01437566

English

Eligibility Breast Cancer NCT01437566

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with er-positive locally advanced breast cancer or metastatic breast cancer (mbc). postmenopausal women with locally advanced breast cancer or metastatic breast cancer whose disease has progressed during or after treatment with an aromatase inhibitor. part ii: postmenopausal women with locally advanced pik3ca-mutant breast cancer or pik3ca-mutant mbc that has progressed during or after treatment with an ai.
Description

Locally advanced breast cancer Estrogen receptor positive | Secondary malignant neoplasm of female breast Estrogen receptor positive | Postmenopausal state | Disease Progression | Aromatase Inhibitors | Locally advanced breast cancer PIK3CA Gene Mutation | Secondary malignant neoplasm of female breast PIK3CA Gene Mutation

Data type

boolean

Alias
UMLS CUI [1,1]
C3495949
UMLS CUI [1,2]
C0279754
UMLS CUI [2,1]
C0346993
UMLS CUI [2,2]
C0279754
UMLS CUI [3]
C0232970
UMLS CUI [4]
C0242656
UMLS CUI [5]
C0593802
UMLS CUI [6,1]
C3495949
UMLS CUI [6,2]
C3272694
UMLS CUI [7,1]
C0346993
UMLS CUI [7,2]
C3272694
eastern cooperative oncology group (ecog) performance status of 0 or 1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
patients must have measurable disease by recist v1.1 or bone-only disease
Description

Measurable Disease | Bone Disease only

Data type

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2,1]
C0005940
UMLS CUI [2,2]
C0205171
adequate hematologic and end-organ function
Description

Hematologic function | Organ function

Data type

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0678852
estrogen receptor-positive disease and her2-negative disease
Description

Disease Estrogen receptor positive | Disease HER2 Negative

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0279754
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C2348908
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior treatment with fulvestrant, pi3k inhibitor, or mtor inhibitor for advanced breast cancer or mbc
Description

Prior Therapy Advanced breast cancer | Prior Therapy Secondary malignant neoplasm of female breast | fulvestrant | PI3K Inhibitor | mTOR Inhibitors

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C3495917
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C0346993
UMLS CUI [3]
C0935916
UMLS CUI [4]
C1519050
UMLS CUI [5]
C1515672
prior treatment with > one cytotoxic chemotherapy regimens or experienced recurrent or progressive disease on > two endocrine therapies for metastatic breast cancer
Description

Cytotoxic Chemotherapy Quantity | Recurrent disease | Progressive Disease | Hormone Therapy Quantity Secondary malignant neoplasm of female breast

Data type

boolean

Alias
UMLS CUI [1,1]
C0677881
UMLS CUI [1,2]
C1265611
UMLS CUI [2]
C0277556
UMLS CUI [3]
C1335499
UMLS CUI [4,1]
C0279025
UMLS CUI [4,2]
C1265611
UMLS CUI [4,3]
C0346993
history of malabsorption syndrome or other condition that would interfere with enteral absorption
Description

Malabsorption Syndrome | Condition Interferes with Absorption Enteral

Data type

boolean

Alias
UMLS CUI [1]
C0024523
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0237442
UMLS CUI [2,4]
C1304890
history of clinically significant cardiac or pulmonary dysfunction
Description

Cardiac dysfunction | Pulmonary Dysfunction

Data type

boolean

Alias
UMLS CUI [1]
C3277906
UMLS CUI [2]
C1709770
clinically significant history of liver disease
Description

Liver disease

Data type

boolean

Alias
UMLS CUI [1]
C0023895
active uncontrolled autoimmune disease or active inflammatory disease
Description

Autoimmune Disease Uncontrolled | Inflammatory disorder

Data type

boolean

Alias
UMLS CUI [1,1]
C0004364
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C1290884
immunocompromised status
Description

Immunocompromised patient

Data type

boolean

Alias
UMLS CUI [1]
C0085393
symptomatic hypercalcemia
Description

Hypercalcemia Symptomatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0020437
UMLS CUI [1,2]
C0231220
need for current chronic corticosteroid therapy
Description

Patient need for Steroid therapy chronic

Data type

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0149783
UMLS CUI [1,3]
C0205191
pregnancy, lactation, or breastfeeding
Description

Pregnancy | Lactation | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0022925
UMLS CUI [3]
C0006147
known untreated or active central nervous system (cns) metastases other protocol-defined inclusion/exclusion criteria may apply.
Description

CNS metastases Untreated | CNS metastases | Eligibility Criteria Additional

Data type

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0332155
UMLS CUI [2]
C0686377
UMLS CUI [3,1]
C1516637
UMLS CUI [3,2]
C1524062
Back to the top of the page

Similar models

Eligibility Breast Cancer NCT01437566

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Locally advanced breast cancer Estrogen receptor positive | Secondary malignant neoplasm of female breast Estrogen receptor positive | Postmenopausal state | Disease Progression | Aromatase Inhibitors | Locally advanced breast cancer PIK3CA Gene Mutation | Secondary malignant neoplasm of female breast PIK3CA Gene Mutation
Item
patients with er-positive locally advanced breast cancer or metastatic breast cancer (mbc). postmenopausal women with locally advanced breast cancer or metastatic breast cancer whose disease has progressed during or after treatment with an aromatase inhibitor. part ii: postmenopausal women with locally advanced pik3ca-mutant breast cancer or pik3ca-mutant mbc that has progressed during or after treatment with an ai.
boolean
C3495949 (UMLS CUI [1,1])
C0279754 (UMLS CUI [1,2])
C0346993 (UMLS CUI [2,1])
C0279754 (UMLS CUI [2,2])
C0232970 (UMLS CUI [3])
C0242656 (UMLS CUI [4])
C0593802 (UMLS CUI [5])
C3495949 (UMLS CUI [6,1])
C3272694 (UMLS CUI [6,2])
C0346993 (UMLS CUI [7,1])
C3272694 (UMLS CUI [7,2])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Measurable Disease | Bone Disease only
Item
patients must have measurable disease by recist v1.1 or bone-only disease
boolean
C1513041 (UMLS CUI [1])
C0005940 (UMLS CUI [2,1])
C0205171 (UMLS CUI [2,2])
Hematologic function | Organ function
Item
adequate hematologic and end-organ function
boolean
C0221130 (UMLS CUI [1])
C0678852 (UMLS CUI [2])
Disease Estrogen receptor positive | Disease HER2 Negative
Item
estrogen receptor-positive disease and her2-negative disease
boolean
C0012634 (UMLS CUI [1,1])
C0279754 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C2348908 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Prior Therapy Advanced breast cancer | Prior Therapy Secondary malignant neoplasm of female breast | fulvestrant | PI3K Inhibitor | mTOR Inhibitors
Item
prior treatment with fulvestrant, pi3k inhibitor, or mtor inhibitor for advanced breast cancer or mbc
boolean
C1514463 (UMLS CUI [1,1])
C3495917 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C0346993 (UMLS CUI [2,2])
C0935916 (UMLS CUI [3])
C1519050 (UMLS CUI [4])
C1515672 (UMLS CUI [5])
Cytotoxic Chemotherapy Quantity | Recurrent disease | Progressive Disease | Hormone Therapy Quantity Secondary malignant neoplasm of female breast
Item
prior treatment with > one cytotoxic chemotherapy regimens or experienced recurrent or progressive disease on > two endocrine therapies for metastatic breast cancer
boolean
C0677881 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0277556 (UMLS CUI [2])
C1335499 (UMLS CUI [3])
C0279025 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C0346993 (UMLS CUI [4,3])
Malabsorption Syndrome | Condition Interferes with Absorption Enteral
Item
history of malabsorption syndrome or other condition that would interfere with enteral absorption
boolean
C0024523 (UMLS CUI [1])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0237442 (UMLS CUI [2,3])
C1304890 (UMLS CUI [2,4])
Cardiac dysfunction | Pulmonary Dysfunction
Item
history of clinically significant cardiac or pulmonary dysfunction
boolean
C3277906 (UMLS CUI [1])
C1709770 (UMLS CUI [2])
Liver disease
Item
clinically significant history of liver disease
boolean
C0023895 (UMLS CUI [1])
Autoimmune Disease Uncontrolled | Inflammatory disorder
Item
active uncontrolled autoimmune disease or active inflammatory disease
boolean
C0004364 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C1290884 (UMLS CUI [2])
Immunocompromised patient
Item
immunocompromised status
boolean
C0085393 (UMLS CUI [1])
Hypercalcemia Symptomatic
Item
symptomatic hypercalcemia
boolean
C0020437 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Patient need for Steroid therapy chronic
Item
need for current chronic corticosteroid therapy
boolean
C0686904 (UMLS CUI [1,1])
C0149783 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
Pregnancy | Lactation | Breast Feeding
Item
pregnancy, lactation, or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0022925 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
CNS metastases Untreated | CNS metastases | Eligibility Criteria Additional
Item
known untreated or active central nervous system (cns) metastases other protocol-defined inclusion/exclusion criteria may apply.
boolean
C0686377 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0686377 (UMLS CUI [2])
C1516637 (UMLS CUI [3,1])
C1524062 (UMLS CUI [3,2])
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