ID

27068

Descripción

Hormone Receptor Positive Metastatic Breast Cancer (HR+ mBC) BIIB021 Plus Aromasin Schedule Finding; ODM derived from: https://clinicaltrials.gov/show/NCT01004081

Link

https://clinicaltrials.gov/show/NCT01004081

Palabras clave

Versiones (1)
  1. 30/10/17 30/10/17 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

30 de octubre de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01004081

Inglés

Eligibility Breast Cancer NCT01004081

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 18 years of age
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
must have histologically or cytologically confirmed estrogen receptor- positive or progesterone receptor-positive, incurable, locally advanced, or metastatic breast cancer.
Descripción

Oestrogen receptor positive breast cancer | Breast Carcinoma Progesterone receptor positive | Breast Carcinoma incurable | Locally advanced breast cancer | Secondary malignant neoplasm of female breast

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2938924
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C0279759
UMLS CUI [3,1]
C0678222
UMLS CUI [3,2]
C0175969
UMLS CUI [4]
C3495949
UMLS CUI [5]
C0346993
must have disease progression during treatment with a nonsteroidal ai for locally advanced or metastatic disease, or relapse during treatment or within 12 months of discontinuation of treatment in the adjuvant setting.
Descripción

Disease Progression | Non-Steroidal Aromatase Inhibitor Advanced disease Local | Non-Steroidal Aromatase Inhibitor Neoplasm Metastasis | Recurrent disease | Discontinuation Adjuvant therapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2,1]
C1518386
UMLS CUI [2,2]
C0679246
UMLS CUI [2,3]
C0205276
UMLS CUI [3,1]
C1518386
UMLS CUI [3,2]
C0027627
UMLS CUI [4]
C0277556
UMLS CUI [5,1]
C0457454
UMLS CUI [5,2]
C0677850
must be a postmenopausal female.
Descripción

Postmenopausal state

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232970
must have measurable or evaluable disease.
Descripción

Measurable Disease | Evaluable Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C1516986
measurable disease is defined as >=1 lesion with a diameter of >=10 mm
Descripción

Measurable Disease | Lesion Quantity Diameter

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C1301886
evaluable disease is defined as bone lesions evaluable by plain x ray, ct scan, or mri. lesions identified only by radionuclide bone scan are not allowed.
Descripción

Evaluable Disease | Bone lesion Plain x-ray | Bone lesion CT scan | Bone lesion MRI | Radioisotope scan of bone only Excluded

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1516986
UMLS CUI [2,1]
C0238792
UMLS CUI [2,2]
C1306645
UMLS CUI [3,1]
C0238792
UMLS CUI [3,2]
C0040405
UMLS CUI [4,1]
C0238792
UMLS CUI [4,2]
C0024485
UMLS CUI [5,1]
C0203668
UMLS CUI [5,2]
C0205171
UMLS CUI [5,3]
C2828389
one prior chemotherapy regimen for advanced mbc is allowed.
Descripción

Chemotherapy Quantity Secondary malignant neoplasm of female breast Advanced

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0346993
UMLS CUI [1,4]
C0205179
prior radiotherapy is allowed.
Descripción

Prior radiation therapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0279134
must be able to swallow and retain oral medication.
Descripción

Able to swallow Oral medication | Ability Retain Oral medication

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0175795
UMLS CUI [2,1]
C0085732
UMLS CUI [2,2]
C0333118
UMLS CUI [2,3]
C0175795
ecog performance status of <=2
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
required laboratory values
Descripción

Laboratory Results Required

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C1514873
plasma cortisol and adrenocorticotropic hormone (acth) levels that are not suggestive of adrenal insufficiency unless on replacement therapy for known adrenal insufficiency.
Descripción

Plasma cortisol measurement | Adrenocorticotropic hormone measurement | Adrenal gland hypofunction Evidence Lacking | Exception Replacement therapy Adrenal gland hypofunction

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1281899
UMLS CUI [2]
C0201835
UMLS CUI [3,1]
C0001623
UMLS CUI [3,2]
C3887511
UMLS CUI [3,3]
C0332268
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0279033
UMLS CUI [4,3]
C0001623
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
her2 overexpressing tumor.
Descripción

Neoplasm HER2 Overexpression

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0069515
UMLS CUI [1,3]
C1514559
history of central nervous system (cns) metastasis.
Descripción

CNS metastases

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0686377
previous treatment with exemestane or treatment with an hsp90 inhibitor.
Descripción

Exemestane | HSP90 Inhibitor

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0851344
UMLS CUI [2,1]
C0243044
UMLS CUI [2,2]
C1999216
use of proton pump inhibitors.
Descripción

Proton Pump Inhibitors

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0358591
known history of or positive test result for hepatitis b or c or hiv.
Descripción

Hepatitis B | Hepatitis C | HIV Infection | Hepatitis B test positive | Hepatitis C test positive | HIV Seropositivity

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
UMLS CUI [3]
C0019693
UMLS CUI [4]
C1608966
UMLS CUI [5]
C1609517
UMLS CUI [6]
C0019699
history of gastrectomy or major surgery to small intestine.
Descripción

Gastrectomy | Major surgery Small Intestine

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0017118
UMLS CUI [2,1]
C0679637
UMLS CUI [2,2]
C0021852
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Similar models

Eligibility Breast Cancer NCT01004081

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 18 years of age
boolean
C0001779 (UMLS CUI [1])
Oestrogen receptor positive breast cancer | Breast Carcinoma Progesterone receptor positive | Breast Carcinoma incurable | Locally advanced breast cancer | Secondary malignant neoplasm of female breast
Item
must have histologically or cytologically confirmed estrogen receptor- positive or progesterone receptor-positive, incurable, locally advanced, or metastatic breast cancer.
boolean
C2938924 (UMLS CUI [1])
C0678222 (UMLS CUI [2,1])
C0279759 (UMLS CUI [2,2])
C0678222 (UMLS CUI [3,1])
C0175969 (UMLS CUI [3,2])
C3495949 (UMLS CUI [4])
C0346993 (UMLS CUI [5])
Disease Progression | Non-Steroidal Aromatase Inhibitor Advanced disease Local | Non-Steroidal Aromatase Inhibitor Neoplasm Metastasis | Recurrent disease | Discontinuation Adjuvant therapy
Item
must have disease progression during treatment with a nonsteroidal ai for locally advanced or metastatic disease, or relapse during treatment or within 12 months of discontinuation of treatment in the adjuvant setting.
boolean
C0242656 (UMLS CUI [1])
C1518386 (UMLS CUI [2,1])
C0679246 (UMLS CUI [2,2])
C0205276 (UMLS CUI [2,3])
C1518386 (UMLS CUI [3,1])
C0027627 (UMLS CUI [3,2])
C0277556 (UMLS CUI [4])
C0457454 (UMLS CUI [5,1])
C0677850 (UMLS CUI [5,2])
Postmenopausal state
Item
must be a postmenopausal female.
boolean
C0232970 (UMLS CUI [1])
Measurable Disease | Evaluable Disease
Item
must have measurable or evaluable disease.
boolean
C1513041 (UMLS CUI [1])
C1516986 (UMLS CUI [2])
Measurable Disease | Lesion Quantity Diameter
Item
measurable disease is defined as >=1 lesion with a diameter of >=10 mm
boolean
C1513041 (UMLS CUI [1])
C0221198 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1301886 (UMLS CUI [2,3])
Evaluable Disease | Bone lesion Plain x-ray | Bone lesion CT scan | Bone lesion MRI | Radioisotope scan of bone only Excluded
Item
evaluable disease is defined as bone lesions evaluable by plain x ray, ct scan, or mri. lesions identified only by radionuclide bone scan are not allowed.
boolean
C1516986 (UMLS CUI [1])
C0238792 (UMLS CUI [2,1])
C1306645 (UMLS CUI [2,2])
C0238792 (UMLS CUI [3,1])
C0040405 (UMLS CUI [3,2])
C0238792 (UMLS CUI [4,1])
C0024485 (UMLS CUI [4,2])
C0203668 (UMLS CUI [5,1])
C0205171 (UMLS CUI [5,2])
C2828389 (UMLS CUI [5,3])
Chemotherapy Quantity Secondary malignant neoplasm of female breast Advanced
Item
one prior chemotherapy regimen for advanced mbc is allowed.
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0346993 (UMLS CUI [1,3])
C0205179 (UMLS CUI [1,4])
Prior radiation therapy
Item
prior radiotherapy is allowed.
boolean
C0279134 (UMLS CUI [1])
Able to swallow Oral medication | Ability Retain Oral medication
Item
must be able to swallow and retain oral medication.
boolean
C2712086 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
C0085732 (UMLS CUI [2,1])
C0333118 (UMLS CUI [2,2])
C0175795 (UMLS CUI [2,3])
ECOG performance status
Item
ecog performance status of <=2
boolean
C1520224 (UMLS CUI [1])
Laboratory Results Required
Item
required laboratory values
boolean
C1254595 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
Plasma cortisol measurement | Adrenocorticotropic hormone measurement | Adrenal gland hypofunction Evidence Lacking | Exception Replacement therapy Adrenal gland hypofunction
Item
plasma cortisol and adrenocorticotropic hormone (acth) levels that are not suggestive of adrenal insufficiency unless on replacement therapy for known adrenal insufficiency.
boolean
C1281899 (UMLS CUI [1])
C0201835 (UMLS CUI [2])
C0001623 (UMLS CUI [3,1])
C3887511 (UMLS CUI [3,2])
C0332268 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0279033 (UMLS CUI [4,2])
C0001623 (UMLS CUI [4,3])
Item Group
C0680251 (UMLS CUI)
Neoplasm HER2 Overexpression
Item
her2 overexpressing tumor.
boolean
C0027651 (UMLS CUI [1,1])
C0069515 (UMLS CUI [1,2])
C1514559 (UMLS CUI [1,3])
CNS metastases
Item
history of central nervous system (cns) metastasis.
boolean
C0686377 (UMLS CUI [1])
Exemestane | HSP90 Inhibitor
Item
previous treatment with exemestane or treatment with an hsp90 inhibitor.
boolean
C0851344 (UMLS CUI [1])
C0243044 (UMLS CUI [2,1])
C1999216 (UMLS CUI [2,2])
Proton Pump Inhibitors
Item
use of proton pump inhibitors.
boolean
C0358591 (UMLS CUI [1])
Hepatitis B | Hepatitis C | HIV Infection | Hepatitis B test positive | Hepatitis C test positive | HIV Seropositivity
Item
known history of or positive test result for hepatitis b or c or hiv.
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0019693 (UMLS CUI [3])
C1608966 (UMLS CUI [4])
C1609517 (UMLS CUI [5])
C0019699 (UMLS CUI [6])
Gastrectomy | Major surgery Small Intestine
Item
history of gastrectomy or major surgery to small intestine.
boolean
C0017118 (UMLS CUI [1])
C0679637 (UMLS CUI [2,1])
C0021852 (UMLS CUI [2,2])
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