ID

26614

Description

Everolimus in Combination With Exemestane in the Treatment of Postmenopausal Women With Estrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer Who Are Refractory to Letrozole or Anastrozole; ODM derived from: https://clinicaltrials.gov/show/NCT00863655

Link

https://clinicaltrials.gov/show/NCT00863655

Keywords

Versions (1)
  1. 10/22/17 10/22/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 22, 2017

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 NCT00863655

English

Eligibility Breast Cancer NCT00863655

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult women (≥ 18 years of age) with metastatic or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy.
Description

Adult | Gender | Age | Secondary malignant neoplasm of female breast | Locally advanced breast cancer | Curative Surgery Unsuccessful | Therapeutic radiology procedure Curative Unsuccessful

Data type

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0001779
UMLS CUI [4]
C0346993
UMLS CUI [5]
C3495949
UMLS CUI [6,1]
C1511562
UMLS CUI [6,2]
C1272705
UMLS CUI [7,1]
C1522449
UMLS CUI [7,2]
C1276305
UMLS CUI [7,3]
C1272705
histological or cytological confirmation of estrogen-receptor positive (er+) breast cancer
Description

Oestrogen receptor positive breast cancer

Data type

boolean

Alias
UMLS CUI [1]
C2938924
postmenopausal women.
Description

Postmenopausal state

Data type

boolean

Alias
UMLS CUI [1]
C0232970
disease refractory to non steroidal aromatase inhibitors (nsai),
Description

Refractory Disease Non-Steroidal Aromatase Inhibitor

Data type

boolean

Alias
UMLS CUI [1,1]
C1514815
UMLS CUI [1,2]
C1518386
radiological or clinical evidence of recurrence or progression on or after the last systemic therapy prior to randomization.
Description

Systemic therapy | Disease recurrence | Disease Progression

Data type

boolean

Alias
UMLS CUI [1]
C1515119
UMLS CUI [2]
C0679254
UMLS CUI [3]
C0242656
patients must have at least one lesion that can be accurately measured or bone lesions in the absence of measurable disease as defined above.
Description

Measurable lesion Quantity | Bone lesion Associated with Absence of Measurable Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C0238792
UMLS CUI [2,2]
C0332281
UMLS CUI [2,3]
C0332197
UMLS CUI [2,4]
C1513041
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
her2-overexpressing patients
Description

HER2 Overexpression

Data type

boolean

Alias
UMLS CUI [1,1]
C0069515
UMLS CUI [1,2]
C1514559
patients with only non-measurable lesions other than bone metastasis (e.g. pleural effusion, ascites etc.).
Description

Non-Measurable Lesion only | Pleural effusion | Ascites | Exception Secondary malignant neoplasm of bone

Data type

boolean

Alias
UMLS CUI [1,1]
C1334988
UMLS CUI [1,2]
C0205171
UMLS CUI [2]
C0032227
UMLS CUI [3]
C0003962
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0153690
patients who received more than one chemotherapy line for advanced breast cancer.
Description

Chemotherapy Quantity Advanced breast cancer

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C3495917
previous treatment with exemestane or mtor inhibitors.
Description

exemestane | mTOR Inhibitor

Data type

boolean

Alias
UMLS CUI [1]
C0851344
UMLS CUI [2]
C2746052
known hypersensitivity to mtor inhibitors, e.g. sirolimus (rapamycin).
Description

Hypersensitivity mTOR Inhibitor | Hypersensitivity Sirolimus

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2746052
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0072980
radiotherapy within four weeks prior to randomization
Description

Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1]
C1522449
currently receiving hormone replacement therapy,
Description

Hormone replacement therapy

Data type

boolean

Alias
UMLS CUI [1]
C0282402
other protocol-defined inclusion/exclusion criteria may apply
Description

Clinical Trial Eligibility Criteria Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
Back to the top of the page

Similar models

Eligibility Breast Cancer NCT00863655

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Gender | Age | Secondary malignant neoplasm of female breast | Locally advanced breast cancer | Curative Surgery Unsuccessful | Therapeutic radiology procedure Curative Unsuccessful
Item
adult women (≥ 18 years of age) with metastatic or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy.
boolean
C0001675 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
C0346993 (UMLS CUI [4])
C3495949 (UMLS CUI [5])
C1511562 (UMLS CUI [6,1])
C1272705 (UMLS CUI [6,2])
C1522449 (UMLS CUI [7,1])
C1276305 (UMLS CUI [7,2])
C1272705 (UMLS CUI [7,3])
Oestrogen receptor positive breast cancer
Item
histological or cytological confirmation of estrogen-receptor positive (er+) breast cancer
boolean
C2938924 (UMLS CUI [1])
Postmenopausal state
Item
postmenopausal women.
boolean
C0232970 (UMLS CUI [1])
Refractory Disease Non-Steroidal Aromatase Inhibitor
Item
disease refractory to non steroidal aromatase inhibitors (nsai),
boolean
C1514815 (UMLS CUI [1,1])
C1518386 (UMLS CUI [1,2])
Systemic therapy | Disease recurrence | Disease Progression
Item
radiological or clinical evidence of recurrence or progression on or after the last systemic therapy prior to randomization.
boolean
C1515119 (UMLS CUI [1])
C0679254 (UMLS CUI [2])
C0242656 (UMLS CUI [3])
Measurable lesion Quantity | Bone lesion Associated with Absence of Measurable Disease
Item
patients must have at least one lesion that can be accurately measured or bone lesions in the absence of measurable disease as defined above.
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0238792 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C1513041 (UMLS CUI [2,4])
Item Group
C0680251 (UMLS CUI)
HER2 Overexpression
Item
her2-overexpressing patients
boolean
C0069515 (UMLS CUI [1,1])
C1514559 (UMLS CUI [1,2])
Non-Measurable Lesion only | Pleural effusion | Ascites | Exception Secondary malignant neoplasm of bone
Item
patients with only non-measurable lesions other than bone metastasis (e.g. pleural effusion, ascites etc.).
boolean
C1334988 (UMLS CUI [1,1])
C0205171 (UMLS CUI [1,2])
C0032227 (UMLS CUI [2])
C0003962 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0153690 (UMLS CUI [4,2])
Chemotherapy Quantity Advanced breast cancer
Item
patients who received more than one chemotherapy line for advanced breast cancer.
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C3495917 (UMLS CUI [1,3])
exemestane | mTOR Inhibitor
Item
previous treatment with exemestane or mtor inhibitors.
boolean
C0851344 (UMLS CUI [1])
C2746052 (UMLS CUI [2])
Hypersensitivity mTOR Inhibitor | Hypersensitivity Sirolimus
Item
known hypersensitivity to mtor inhibitors, e.g. sirolimus (rapamycin).
boolean
C0020517 (UMLS CUI [1,1])
C2746052 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0072980 (UMLS CUI [2,2])
Therapeutic radiology procedure
Item
radiotherapy within four weeks prior to randomization
boolean
C1522449 (UMLS CUI [1])
Hormone replacement therapy
Item
currently receiving hormone replacement therapy,
boolean
C0282402 (UMLS CUI [1])
Clinical Trial Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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