ID

14881

Descripción

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

Palabras clave

Versiones (1)
  1. 3/5/16 3/5/16 -
Subido en

3 de mayo de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT02297438

Inglés

Eligibility Breast Neoplasms NCT02297438

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

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

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

Tipo de datos

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
Descripción

Breast Carcinoma Positive

Tipo de datos

boolean

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

cancer treatment Systemic Previous | Estrogen receptor positive tumor Advanced phase

Tipo de datos

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
Descripción

Postmenopausal state

Tipo de datos

boolean

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

Measurable Disease Response Evaluation Criteria in Solid Tumors | Bone Diseases

Tipo de datos

boolean

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

ECOG performance status

Tipo de datos

boolean

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

body system or organ function Adequate | Bone Marrow Function Adequate

Tipo de datos

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
Descripción

Agree Providing Tumor tissue sample

Tipo de datos

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
confirmed diagnosis of her2 positive disease
Descripción

erbB-2 Receptor Positive Disease

Tipo de datos

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
Descripción

Visceral Neoplasm Metastasis Advanced phase Symptomatic | Complication Life Threatening

Tipo de datos

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
Descripción

CNS metastases Uncontrolled | CNS metastases Symptomatic

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

Prior Therapy Cyclin-Dependent Kinase Inhibitor Agents

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1511576
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Similar models

Eligibility Breast Neoplasms NCT02297438

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
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