ID

16164

Descripción

A Phase 1/2 Study Of HKI-272 (Neratinib) in Combination With Trastuzumab (Herceptin) In Subjects With Advanced Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00398567

Link

https://clinicaltrials.gov/show/NCT00398567

Palabras clave

Versiones (1)
  1. 3/7/16 3/7/16 -
Subido en

3 de julio de 2016

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 Advanced Breast Cancer NCT00398567

Inglés

Eligibility Advanced Breast Cancer NCT00398567

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
pathologic diagnosis of breast cancer with current stage iiib, iiic or iv not curable by available therapy
Descripción

breast cancer

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0678222
progression following at least one herceptin-containing cytotoxic chemotherapy regimen (neoadjuvant, adjuvant, or metastatic setting)
Descripción

herceptin-containing cytotoxic chemotherapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0338204
UMLS CUI [1,2]
C0392920
her2 positive breast cancer
Descripción

her2 positive breast cancer

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3251092
at least one measurable target lesion
Descripción

at least one measurable target lesion

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2986546
adequate performance status
Descripción

performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
adequate cardiac, kidney, and liver function
Descripción

cardiac, kidney, and liver function

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232741
adequate blood counts
Descripción

blood count

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0005771
willingness of all subjects who are not surgically sterile or post menopausal to use acceptable methods of birth control
Descripción

birth control

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0700589
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
more than 3 prior cytotoxic chemotherapy regimens for locally advanced or metastatic disease
Descripción

cytotoxic chemotherapy regimen

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0027627
major surgery, chemotherapy, radiotherapy, investigational agents, herceptin or other cancer therapy within 2 weeks of treatment day 1
Descripción

major surgery

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2]
C0338204
prior treatment with anthracyclines with cumulative dose of >400 mg/m^2
Descripción

anthracyclines

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3653626
extensive visceral disease
Descripción

visceral disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0234245
active central nervous system metastases
Descripción

central nervous system metastases

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0686377
pregnant or breast feeding women
Descripción

pregnant or breast feeding women

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
significant chronic or recent acute gastrointestinal disorder with diarrhea as a major symptom
Descripción

gastrointestinal disorder

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0017178
prior exposure to hki-272 or other her2 targeted agents (except herceptin and tykerb)
Descripción

prior exposure to hki-272 or other her2 targeted agents

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1454298
significant cardiac disease or dysfunction
Descripción

cardiac disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0018799
history of life-threatening hypersensitivity to herceptin
Descripción

hypersensitivity to herceptin

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0338204
inability or unwillingness to swallow hki-272 capsules
Descripción

swallow hki-272 capsules

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0566355
any other cancer within 5 years with the exception of contralateral breast cancer, adequately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin
Descripción

cancer

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1274082
UMLS CUI [1,2]
C2598420
Volver a la parte superior de la página

Similar models

Eligibility Advanced Breast Cancer NCT00398567

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
breast cancer
Item
pathologic diagnosis of breast cancer with current stage iiib, iiic or iv not curable by available therapy
boolean
C0678222 (UMLS CUI [1])
herceptin-containing cytotoxic chemotherapy
Item
progression following at least one herceptin-containing cytotoxic chemotherapy regimen (neoadjuvant, adjuvant, or metastatic setting)
boolean
C0338204 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
her2 positive breast cancer
Item
her2 positive breast cancer
boolean
C3251092 (UMLS CUI [1])
at least one measurable target lesion
Item
at least one measurable target lesion
boolean
C2986546 (UMLS CUI [1])
performance status
Item
adequate performance status
boolean
C1520224 (UMLS CUI [1])
cardiac, kidney, and liver function
Item
adequate cardiac, kidney, and liver function
boolean
C0232741 (UMLS CUI [1])
blood count
Item
adequate blood counts
boolean
C0005771 (UMLS CUI [1])
birth control
Item
willingness of all subjects who are not surgically sterile or post menopausal to use acceptable methods of birth control
boolean
C0700589 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
cytotoxic chemotherapy regimen
Item
more than 3 prior cytotoxic chemotherapy regimens for locally advanced or metastatic disease
boolean
C0392920 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
major surgery
Item
major surgery, chemotherapy, radiotherapy, investigational agents, herceptin or other cancer therapy within 2 weeks of treatment day 1
boolean
C0679637 (UMLS CUI [1])
C0338204 (UMLS CUI [2])
anthracyclines
Item
prior treatment with anthracyclines with cumulative dose of >400 mg/m^2
boolean
C3653626 (UMLS CUI [1])
visceral disease
Item
extensive visceral disease
boolean
C0234245 (UMLS CUI [1])
central nervous system metastases
Item
active central nervous system metastases
boolean
C0686377 (UMLS CUI [1])
pregnant or breast feeding women
Item
pregnant or breast feeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
gastrointestinal disorder
Item
significant chronic or recent acute gastrointestinal disorder with diarrhea as a major symptom
boolean
C0017178 (UMLS CUI [1])
prior exposure to hki-272 or other her2 targeted agents
Item
prior exposure to hki-272 or other her2 targeted agents (except herceptin and tykerb)
boolean
C1454298 (UMLS CUI [1])
cardiac disease
Item
significant cardiac disease or dysfunction
boolean
C0018799 (UMLS CUI [1])
hypersensitivity to herceptin
Item
history of life-threatening hypersensitivity to herceptin
boolean
C0020517 (UMLS CUI [1,1])
C0338204 (UMLS CUI [1,2])
swallow hki-272 capsules
Item
inability or unwillingness to swallow hki-272 capsules
boolean
C0566355 (UMLS CUI [1])
cancer
Item
any other cancer within 5 years with the exception of contralateral breast cancer, adequately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin
boolean
C1274082 (UMLS CUI [1,1])
C2598420 (UMLS CUI [1,2])
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