ID

26614

Descrição

Everolimus in Combination With Exemestane in the Treatment of Postmenopausal Women With Estrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer Who Are Refractory to Letrozole or Anastrozole; ODM derived from: https://clinicaltrials.gov/show/NCT00863655

Link

https://clinicaltrials.gov/show/NCT00863655

Palavras-chave

Versões (1)
  1. 22/10/2017 22/10/2017 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

22 de outubro de 2017

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00863655

Inglês

Eligibility Breast Cancer NCT00863655

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult women (≥ 18 years of age) with metastatic or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy.
Descrição

Adult | Gender | Age | Secondary malignant neoplasm of female breast | Locally advanced breast cancer | Curative Surgery Unsuccessful | Therapeutic radiology procedure Curative Unsuccessful

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0001779
UMLS CUI [4]
C0346993
UMLS CUI [5]
C3495949
UMLS CUI [6,1]
C1511562
UMLS CUI [6,2]
C1272705
UMLS CUI [7,1]
C1522449
UMLS CUI [7,2]
C1276305
UMLS CUI [7,3]
C1272705
histological or cytological confirmation of estrogen-receptor positive (er+) breast cancer
Descrição

Oestrogen receptor positive breast cancer

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2938924
postmenopausal women.
Descrição

Postmenopausal state

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0232970
disease refractory to non steroidal aromatase inhibitors (nsai),
Descrição

Refractory Disease Non-Steroidal Aromatase Inhibitor

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1514815
UMLS CUI [1,2]
C1518386
radiological or clinical evidence of recurrence or progression on or after the last systemic therapy prior to randomization.
Descrição

Systemic therapy | Disease recurrence | Disease Progression

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1515119
UMLS CUI [2]
C0679254
UMLS CUI [3]
C0242656
patients must have at least one lesion that can be accurately measured or bone lesions in the absence of measurable disease as defined above.
Descrição

Measurable lesion Quantity | Bone lesion Associated with Absence of Measurable Disease

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C0238792
UMLS CUI [2,2]
C0332281
UMLS CUI [2,3]
C0332197
UMLS CUI [2,4]
C1513041
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
her2-overexpressing patients
Descrição

HER2 Overexpression

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0069515
UMLS CUI [1,2]
C1514559
patients with only non-measurable lesions other than bone metastasis (e.g. pleural effusion, ascites etc.).
Descrição

Non-Measurable Lesion only | Pleural effusion | Ascites | Exception Secondary malignant neoplasm of bone

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1334988
UMLS CUI [1,2]
C0205171
UMLS CUI [2]
C0032227
UMLS CUI [3]
C0003962
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0153690
patients who received more than one chemotherapy line for advanced breast cancer.
Descrição

Chemotherapy Quantity Advanced breast cancer

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C3495917
previous treatment with exemestane or mtor inhibitors.
Descrição

exemestane | mTOR Inhibitor

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0851344
UMLS CUI [2]
C2746052
known hypersensitivity to mtor inhibitors, e.g. sirolimus (rapamycin).
Descrição

Hypersensitivity mTOR Inhibitor | Hypersensitivity Sirolimus

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2746052
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0072980
radiotherapy within four weeks prior to randomization
Descrição

Therapeutic radiology procedure

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1522449
currently receiving hormone replacement therapy,
Descrição

Hormone replacement therapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0282402
other protocol-defined inclusion/exclusion criteria may apply
Descrição

Clinical Trial Eligibility Criteria Study Protocol

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Breast Cancer NCT00863655

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Gender | Age | Secondary malignant neoplasm of female breast | Locally advanced breast cancer | Curative Surgery Unsuccessful | Therapeutic radiology procedure Curative Unsuccessful
Item
adult women (≥ 18 years of age) with metastatic or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy.
boolean
C0001675 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
C0346993 (UMLS CUI [4])
C3495949 (UMLS CUI [5])
C1511562 (UMLS CUI [6,1])
C1272705 (UMLS CUI [6,2])
C1522449 (UMLS CUI [7,1])
C1276305 (UMLS CUI [7,2])
C1272705 (UMLS CUI [7,3])
Oestrogen receptor positive breast cancer
Item
histological or cytological confirmation of estrogen-receptor positive (er+) breast cancer
boolean
C2938924 (UMLS CUI [1])
Postmenopausal state
Item
postmenopausal women.
boolean
C0232970 (UMLS CUI [1])
Refractory Disease Non-Steroidal Aromatase Inhibitor
Item
disease refractory to non steroidal aromatase inhibitors (nsai),
boolean
C1514815 (UMLS CUI [1,1])
C1518386 (UMLS CUI [1,2])
Systemic therapy | Disease recurrence | Disease Progression
Item
radiological or clinical evidence of recurrence or progression on or after the last systemic therapy prior to randomization.
boolean
C1515119 (UMLS CUI [1])
C0679254 (UMLS CUI [2])
C0242656 (UMLS CUI [3])
Measurable lesion Quantity | Bone lesion Associated with Absence of Measurable Disease
Item
patients must have at least one lesion that can be accurately measured or bone lesions in the absence of measurable disease as defined above.
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0238792 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C1513041 (UMLS CUI [2,4])
Item Group
C0680251 (UMLS CUI)
HER2 Overexpression
Item
her2-overexpressing patients
boolean
C0069515 (UMLS CUI [1,1])
C1514559 (UMLS CUI [1,2])
Non-Measurable Lesion only | Pleural effusion | Ascites | Exception Secondary malignant neoplasm of bone
Item
patients with only non-measurable lesions other than bone metastasis (e.g. pleural effusion, ascites etc.).
boolean
C1334988 (UMLS CUI [1,1])
C0205171 (UMLS CUI [1,2])
C0032227 (UMLS CUI [2])
C0003962 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0153690 (UMLS CUI [4,2])
Chemotherapy Quantity Advanced breast cancer
Item
patients who received more than one chemotherapy line for advanced breast cancer.
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C3495917 (UMLS CUI [1,3])
exemestane | mTOR Inhibitor
Item
previous treatment with exemestane or mtor inhibitors.
boolean
C0851344 (UMLS CUI [1])
C2746052 (UMLS CUI [2])
Hypersensitivity mTOR Inhibitor | Hypersensitivity Sirolimus
Item
known hypersensitivity to mtor inhibitors, e.g. sirolimus (rapamycin).
boolean
C0020517 (UMLS CUI [1,1])
C2746052 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0072980 (UMLS CUI [2,2])
Therapeutic radiology procedure
Item
radiotherapy within four weeks prior to randomization
boolean
C1522449 (UMLS CUI [1])
Hormone replacement therapy
Item
currently receiving hormone replacement therapy,
boolean
C0282402 (UMLS CUI [1])
Clinical Trial Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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