ID

38333

Description

A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2); ODM derived from: https://clinicaltrials.gov/show/NCT01740427

Link

https://clinicaltrials.gov/show/NCT01740427

Keywords

Versions (1)
  1. 10/11/19 10/11/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 11, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT01740427

English

Eligibility Breast Neoplasms NCT01740427

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Adult | Gender | Recurrent disease Locoregional | Neoplasm Metastasis | Disease Inappropriate Curative treatment

Data type

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0079399
UMLS CUI [3,1]
C0277556
UMLS CUI [3,2]
C1947913
UMLS CUI [4]
C0027627
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C1548788
UMLS CUI [5,3]
C1273390
confirmed diagnosis of er positive breast cancer
Description

Oestrogen receptor positive breast cancer

Data type

boolean

Alias
UMLS CUI [1]
C2938924
no prior systemic anti-cancer therapy for advanced er+ disease.
Description

Cancer treatment Systemic Absent | Advanced disease Estrogen receptor positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205373
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0679246
UMLS CUI [2,2]
C0279754
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 | Bone Disease only

Data type

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2,1]
C0005940
UMLS CUI [2,2]
C0205171
eastern cooperative oncology group [ecog] 0-2
Description

ECOG performance status

Data type

boolean

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

Organ function | Bone Marrow function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
patient must agree to provide tumor tissue
Description

Tumor tissue sample Provide

Data type

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
confirmed diagnosis of her2 positive disease
Description

Disease HER2 Positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348909
patients with advanced, symptomatic, visceral spread that are at risk of life threatening complication in the short term
Description

Spread Visceral Symptomatic Advanced | At risk Complications Life Threatening

Data type

boolean

Alias
UMLS CUI [1,1]
C0332261
UMLS CUI [1,2]
C0442045
UMLS CUI [1,3]
C0231220
UMLS CUI [1,4]
C0205179
UMLS CUI [2,1]
C1444641
UMLS CUI [2,2]
C0009566
UMLS CUI [2,3]
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 (neo)adjuvant treatment with letrozole or anastrozole with dfi ≤ 12-months from completion of treatment.
Description

Adjuvant therapy Letrozole | Adjuvant therapy Anastrozole | Neoadjuvant Therapy Letrozole | Neoadjuvant Therapy Anastrozole | Treatment completed | Interval Disease Free

Data type

boolean

Alias
UMLS CUI [1,1]
C0677850
UMLS CUI [1,2]
C0246421
UMLS CUI [2,1]
C0677850
UMLS CUI [2,2]
C0290883
UMLS CUI [3,1]
C0600558
UMLS CUI [3,2]
C0246421
UMLS CUI [4,1]
C0600558
UMLS CUI [4,2]
C0290883
UMLS CUI [5]
C0580352
UMLS CUI [6,1]
C1272706
UMLS CUI [6,2]
C0012634
UMLS CUI [6,3]
C0332296
prior treatment with any cdk 4/6 inhibitor.
Description

CDK4 Inhibitor | CDK6 Inhibitor

Data type

boolean

Alias
UMLS CUI [1,1]
C0246957
UMLS CUI [1,2]
C1999216
UMLS CUI [2,1]
C0252132
UMLS CUI [2,2]
C1999216
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Similar models

Eligibility Breast Neoplasms NCT01740427

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Gender | Recurrent disease Locoregional | Neoplasm Metastasis | Disease Inappropriate Curative treatment
Item
adult women with locoregionally recurrent or metastatic disease not amenable to curative therapy.
boolean
C0001675 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0277556 (UMLS CUI [3,1])
C1947913 (UMLS CUI [3,2])
C0027627 (UMLS CUI [4])
C0012634 (UMLS CUI [5,1])
C1548788 (UMLS CUI [5,2])
C1273390 (UMLS CUI [5,3])
Oestrogen receptor positive breast cancer
Item
confirmed diagnosis of er positive breast cancer
boolean
C2938924 (UMLS CUI [1])
Cancer treatment Systemic Absent | Advanced disease Estrogen receptor positive
Item
no prior systemic anti-cancer therapy for advanced er+ disease.
boolean
C0920425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0679246 (UMLS CUI [2,1])
C0279754 (UMLS CUI [2,2])
Postmenopausal state
Item
postmenopausal women
boolean
C0232970 (UMLS CUI [1])
Measurable Disease | Bone Disease only
Item
measurable disease as per response evaluation criterion in solid tumors [recist] or bone-only disease
boolean
C1513041 (UMLS CUI [1])
C0005940 (UMLS CUI [2,1])
C0205171 (UMLS CUI [2,2])
ECOG performance status
Item
eastern cooperative oncology group [ecog] 0-2
boolean
C1520224 (UMLS CUI [1])
Organ function | Bone Marrow function
Item
adequate organ and marrow function
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
Tumor tissue sample Provide
Item
patient must agree to provide tumor tissue
boolean
C0475358 (UMLS CUI [1,1])
C1999230 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Disease HER2 Positive
Item
confirmed diagnosis of her2 positive disease
boolean
C0012634 (UMLS CUI [1,1])
C2348909 (UMLS CUI [1,2])
Spread Visceral Symptomatic Advanced | At risk Complications Life Threatening
Item
patients with advanced, symptomatic, visceral spread that are at risk of life threatening complication in the short term
boolean
C0332261 (UMLS CUI [1,1])
C0442045 (UMLS CUI [1,2])
C0231220 (UMLS CUI [1,3])
C0205179 (UMLS CUI [1,4])
C1444641 (UMLS CUI [2,1])
C0009566 (UMLS CUI [2,2])
C2826244 (UMLS CUI [2,3])
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])
Adjuvant therapy Letrozole | Adjuvant therapy Anastrozole | Neoadjuvant Therapy Letrozole | Neoadjuvant Therapy Anastrozole | Treatment completed | Interval Disease Free
Item
prior (neo)adjuvant treatment with letrozole or anastrozole with dfi ≤ 12-months from completion of treatment.
boolean
C0677850 (UMLS CUI [1,1])
C0246421 (UMLS CUI [1,2])
C0677850 (UMLS CUI [2,1])
C0290883 (UMLS CUI [2,2])
C0600558 (UMLS CUI [3,1])
C0246421 (UMLS CUI [3,2])
C0600558 (UMLS CUI [4,1])
C0290883 (UMLS CUI [4,2])
C0580352 (UMLS CUI [5])
C1272706 (UMLS CUI [6,1])
C0012634 (UMLS CUI [6,2])
C0332296 (UMLS CUI [6,3])
CDK4 Inhibitor | CDK6 Inhibitor
Item
prior treatment with any cdk 4/6 inhibitor.
boolean
C0246957 (UMLS CUI [1,1])
C1999216 (UMLS CUI [1,2])
C0252132 (UMLS CUI [2,1])
C1999216 (UMLS CUI [2,2])
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