ID

38333

Descripción

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

Palabras clave

Versiones (1)
  1. 11/10/19 11/10/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

11 de octubre de 2019

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Eligibility Breast Neoplasms NCT01740427

Inglés

Eligibility Breast Neoplasms NCT01740427

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

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

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

Tipo de datos

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
Descripción

Oestrogen receptor positive breast cancer

Tipo de datos

boolean

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

Cancer treatment Systemic Absent | Advanced disease Estrogen receptor positive

Tipo de datos

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
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 | Bone Disease only

Tipo de datos

boolean

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

ECOG performance status

Tipo de datos

boolean

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

Organ function | Bone Marrow function

Tipo de datos

boolean

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

Tumor tissue sample Provide

Tipo de datos

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
confirmed diagnosis of her2 positive disease
Descripción

Disease HER2 Positive

Tipo de datos

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
Descripción

Spread Visceral Symptomatic Advanced | At risk Complications Life Threatening

Tipo de datos

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
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 (neo)adjuvant treatment with letrozole or anastrozole with dfi ≤ 12-months from completion of treatment.
Descripción

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

Tipo de datos

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.
Descripción

CDK4 Inhibitor | CDK6 Inhibitor

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0246957
UMLS CUI [1,2]
C1999216
UMLS CUI [2,1]
C0252132
UMLS CUI [2,2]
C1999216
Volver a la parte superior de la página

Similar models

Eligibility Breast Neoplasms NCT01740427

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

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