ID

19663

Descripción

A Study of Perjeta (Pertuzumab) in Combination With Herceptin in Patients With Metastatic Breast Cancer.; ODM derived from: https://clinicaltrials.gov/show/NCT01674062

Link

https://clinicaltrials.gov/show/NCT01674062

Palabras clave

  1. 20/1/17 20/1/17 -
  2. 20/1/17 20/1/17 -
Subido en

20 de enero de 2017

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.

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 Cancer NCT01674062

Eligibility Breast Cancer NCT01674062

Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients, >=18 years of age, with histologically-confirmed her2-positive breast cancer
Descripción

Adult | Age | HER2-positive carcinoma of breast

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
UMLS CUI [3]
C1960398
metastatic breast cancer, with progression on herceptin-based therapy as last treatment for metastatic disease
Descripción

Secondary malignant neoplasm of female breast | Disease Progression | Therapeutic procedure Herceptin Based Neoplasm Metastasis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0346993
UMLS CUI [2]
C0242656
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0338204
UMLS CUI [3,3]
C1705938
UMLS CUI [3,4]
C0027627
<=3 chemotherapy regimens prior to study entry
Descripción

Chemotherapy Regimen Quantity

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
last herceptin dose <=9 weeks before study entry for patients reciving pertuzumab +
Descripción

Herceptin Dose | pertuzumab

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0338204
UMLS CUI [1,2]
C0178602
UMLS CUI [2]
C1328025
herceptin, and >=4 weeks for patients receiving pertuzumab monotherapy
Descripción

Herceptin | pertuzumab

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0338204
UMLS CUI [2]
C1328025
lvef>= 55% at study entry
Descripción

Left ventricular ejection fraction

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0428772
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous treatment with an anti-cancer vaccine or any targeted therapy other than herceptin
Descripción

Vaccines Against Malignant Neoplasms | Targeted Therapy | Herceptin

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0042210
UMLS CUI [1,2]
C0521124
UMLS CUI [1,3]
C0006826
UMLS CUI [2]
C2985566
UMLS CUI [3]
C0338204
brain metastases
Descripción

Metastatic malignant neoplasm to brain

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0220650
history of any cardiac ae related to herceptin therapy
Descripción

Adverse event cardiac Herceptin Related

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0018787
UMLS CUI [1,3]
C0338204
UMLS CUI [1,4]
C0439849
any other malignancy in the last 5 years, except for basal cell cancer or cancer in situ of the cervix
Descripción

Malignant Neoplasms | Basal cell carcinoma | Carcinoma in situ of uterine cervix

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0007117
UMLS CUI [3]
C0851140

Similar models

Eligibility Breast Cancer NCT01674062

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age | HER2-positive carcinoma of breast
Item
adult patients, >=18 years of age, with histologically-confirmed her2-positive breast cancer
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C1960398 (UMLS CUI [3])
Secondary malignant neoplasm of female breast | Disease Progression | Therapeutic procedure Herceptin Based Neoplasm Metastasis
Item
metastatic breast cancer, with progression on herceptin-based therapy as last treatment for metastatic disease
boolean
C0346993 (UMLS CUI [1])
C0242656 (UMLS CUI [2])
C0087111 (UMLS CUI [3,1])
C0338204 (UMLS CUI [3,2])
C1705938 (UMLS CUI [3,3])
C0027627 (UMLS CUI [3,4])
Chemotherapy Regimen Quantity
Item
<=3 chemotherapy regimens prior to study entry
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Herceptin Dose | pertuzumab
Item
last herceptin dose <=9 weeks before study entry for patients reciving pertuzumab +
boolean
C0338204 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1328025 (UMLS CUI [2])
Herceptin | pertuzumab
Item
herceptin, and >=4 weeks for patients receiving pertuzumab monotherapy
boolean
C0338204 (UMLS CUI [1])
C1328025 (UMLS CUI [2])
Left ventricular ejection fraction
Item
lvef>= 55% at study entry
boolean
C0428772 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Vaccines Against Malignant Neoplasms | Targeted Therapy | Herceptin
Item
previous treatment with an anti-cancer vaccine or any targeted therapy other than herceptin
boolean
C0042210 (UMLS CUI [1,1])
C0521124 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
C2985566 (UMLS CUI [2])
C0338204 (UMLS CUI [3])
Metastatic malignant neoplasm to brain
Item
brain metastases
boolean
C0220650 (UMLS CUI [1])
Adverse event cardiac Herceptin Related
Item
history of any cardiac ae related to herceptin therapy
boolean
C0877248 (UMLS CUI [1,1])
C0018787 (UMLS CUI [1,2])
C0338204 (UMLS CUI [1,3])
C0439849 (UMLS CUI [1,4])
Malignant Neoplasms | Basal cell carcinoma | Carcinoma in situ of uterine cervix
Item
any other malignancy in the last 5 years, except for basal cell cancer or cancer in situ of the cervix
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2])
C0851140 (UMLS CUI [3])

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

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