ID

14881

Description

A Study Of Palbociclib (PD-0332991) + Letrozole VS. Placebo+ Letrozole For 1st Line Treatment Of Asian Postmenopausal Women With ER+/HER2- Advanced Breast Cancer [PALOMA-4]; ODM derived from: https://clinicaltrials.gov/show/NCT02297438

Link

https://clinicaltrials.gov/show/NCT02297438

Keywords

Versions (1)
  1. 5/3/16 5/3/16 -
Uploaded on

May 3, 2016

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 Neoplasms NCT02297438

English

Eligibility Breast Neoplasms NCT02297438

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult asian women with locoregionally recurrent or metastatic disease not amenable to curative therapy
Description

Gender | Adult | Asians | Recurrent disease | Neoplasm Metastasis | curative treatment

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001675
UMLS CUI [3]
C0078988
UMLS CUI [4]
C0277556
UMLS CUI [5]
C0027627
UMLS CUI [6]
C1273390
confirmed diagnosis of er positive breast cancer
Description

Breast Carcinoma Positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C1446409
no prior systemic anti-cancer therapy for advanced er+ disease
Description

cancer treatment Systemic Previous | Estrogen receptor positive tumor Advanced phase

Data type

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205373
UMLS CUI [1,3]
C0205156
UMLS CUI [2,1]
C1562312
UMLS CUI [2,2]
C0205179
postmenopausal women
Description

Postmenopausal state

Data type

boolean

Alias
UMLS CUI [1]
C0232970
measurable disease as per response evaluation criterion in solid tumors [recist] or bone-only disease
Description

Measurable Disease Response Evaluation Criteria in Solid Tumors | Bone Diseases

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1709926
UMLS CUI [2]
C0005940
eastern cooperative oncology group [ecog] 0-1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
adequate organ and marrow function
Description

body system or organ function Adequate | Bone Marrow Function Adequate

Data type

boolean

Alias
UMLS CUI [1,1]
C0678852
UMLS CUI [1,2]
C0205411
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0542341
UMLS CUI [2,3]
C0205411
patient must agree to provide tumor tissue
Description

Agree Providing Tumor tissue sample

Data type

boolean

Alias
UMLS CUI [1,1]
C3641827
UMLS CUI [1,2]
C1999230
UMLS CUI [1,3]
C0475358
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
confirmed diagnosis of her2 positive disease
Description

erbB-2 Receptor Positive Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0069515
UMLS CUI [1,2]
C1446409
UMLS CUI [1,3]
C0012634
patients with advanced, symptomatic, visceral spread that are at risk of life threatening complication in the short term
Description

Visceral Neoplasm Metastasis Advanced phase Symptomatic | Complication Life Threatening

Data type

boolean

Alias
UMLS CUI [1,1]
C0442045
UMLS CUI [1,2]
C0027627
UMLS CUI [1,3]
C0205179
UMLS CUI [1,4]
C0231220
UMLS CUI [2,1]
C0009566
UMLS CUI [2,2]
C2826244
known uncontrolled or symptomatic cns metastases
Description

CNS metastases Uncontrolled | CNS metastases Symptomatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0686377
UMLS CUI [2,2]
C0231220
prior neoadjuvant or adjuvant treatment with a non steroidal aromatase inhibitor (ie, anastrozole or letrozole) with disease recurrence while on or within 12 months of completing treatment
Description

Neoadjuvant Therapy | Adjuvant therapy | Non-Steroidal Aromatase Inhibitor | anastrozole | letrozole | Disease recurrence

Data type

boolean

Alias
UMLS CUI [1]
C0600558
UMLS CUI [2]
C0677850
UMLS CUI [3]
C1518386
UMLS CUI [4]
C0290883
UMLS CUI [5]
C0246421
UMLS CUI [6]
C0679254
prior treatment with any cdk 4/6 inhibitor
Description

Prior Therapy Cyclin-Dependent Kinase Inhibitor Agents

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1511576
Back to the top of the page

Similar models

Eligibility Breast Neoplasms NCT02297438

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Adult | Asians | Recurrent disease | Neoplasm Metastasis | curative treatment
Item
adult asian women with locoregionally recurrent or metastatic disease not amenable to curative therapy
boolean
C0079399 (UMLS CUI [1])
C0001675 (UMLS CUI [2])
C0078988 (UMLS CUI [3])
C0277556 (UMLS CUI [4])
C0027627 (UMLS CUI [5])
C1273390 (UMLS CUI [6])
Breast Carcinoma Positive
Item
confirmed diagnosis of er positive breast cancer
boolean
C0678222 (UMLS CUI [1,1])
C1446409 (UMLS CUI [1,2])
cancer treatment Systemic Previous | Estrogen receptor positive tumor Advanced phase
Item
no prior systemic anti-cancer therapy for advanced er+ disease
boolean
C0920425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
C1562312 (UMLS CUI [2,1])
C0205179 (UMLS CUI [2,2])
Postmenopausal state
Item
postmenopausal women
boolean
C0232970 (UMLS CUI [1])
Measurable Disease Response Evaluation Criteria in Solid Tumors | Bone Diseases
Item
measurable disease as per response evaluation criterion in solid tumors [recist] or bone-only disease
boolean
C1513041 (UMLS CUI [1,1])
C1709926 (UMLS CUI [1,2])
C0005940 (UMLS CUI [2])
ECOG performance status
Item
eastern cooperative oncology group [ecog] 0-1
boolean
C1520224 (UMLS CUI [1])
body system or organ function Adequate | Bone Marrow Function Adequate
Item
adequate organ and marrow function
boolean
C0678852 (UMLS CUI [1,1])
C0205411 (UMLS CUI [1,2])
C0005953 (UMLS CUI [2,1])
C0542341 (UMLS CUI [2,2])
C0205411 (UMLS CUI [2,3])
Agree Providing Tumor tissue sample
Item
patient must agree to provide tumor tissue
boolean
C3641827 (UMLS CUI [1,1])
C1999230 (UMLS CUI [1,2])
C0475358 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
erbB-2 Receptor Positive Disease
Item
confirmed diagnosis of her2 positive disease
boolean
C0069515 (UMLS CUI [1,1])
C1446409 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
Visceral Neoplasm Metastasis Advanced phase Symptomatic | Complication Life Threatening
Item
patients with advanced, symptomatic, visceral spread that are at risk of life threatening complication in the short term
boolean
C0442045 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
C0205179 (UMLS CUI [1,3])
C0231220 (UMLS CUI [1,4])
C0009566 (UMLS CUI [2,1])
C2826244 (UMLS CUI [2,2])
CNS metastases Uncontrolled | CNS metastases Symptomatic
Item
known uncontrolled or symptomatic cns metastases
boolean
C0686377 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0686377 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
Neoadjuvant Therapy | Adjuvant therapy | Non-Steroidal Aromatase Inhibitor | anastrozole | letrozole | Disease recurrence
Item
prior neoadjuvant or adjuvant treatment with a non steroidal aromatase inhibitor (ie, anastrozole or letrozole) with disease recurrence while on or within 12 months of completing treatment
boolean
C0600558 (UMLS CUI [1])
C0677850 (UMLS CUI [2])
C1518386 (UMLS CUI [3])
C0290883 (UMLS CUI [4])
C0246421 (UMLS CUI [5])
C0679254 (UMLS CUI [6])
Prior Therapy Cyclin-Dependent Kinase Inhibitor Agents
Item
prior treatment with any cdk 4/6 inhibitor
boolean
C1514463 (UMLS CUI [1,1])
C1511576 (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