ID

16431

Descrição

Study in Women With Metastatic Breast Cancer Whose Cancer Has Gotten Worse After Anthracycline and Taxane Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT00067314

Link

https://clinicaltrials.gov/show/NCT00067314

Palavras-chave

Versões (1)
  1. 16/07/2016 16/07/2016 -
Transferido a

16 de julho de 2016

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT00067314

Inglês

Eligibility Breast Neoplasms NCT00067314

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
locally advanced or metastatic breast cancer not amenable to surgery or radiation with curative intent
Descrição

Locally advanced breast cancer Amenable Operative Surgical Procedures | Carcinoma breast stage IV Amenable Operative Surgical Procedures | Locally advanced breast cancer Amenable Therapeutic radiology procedure Curative | Carcinoma breast stage IV Amenable Therapeutic radiology procedure Curative

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3495949
UMLS CUI [1,2]
C3900053
UMLS CUI [1,3]
C0543467
UMLS CUI [2,1]
C0278488
UMLS CUI [2,2]
C3900053
UMLS CUI [2,3]
C0543467
UMLS CUI [3,1]
C3495949
UMLS CUI [3,2]
C3900053
UMLS CUI [3,3]
C1522449
UMLS CUI [3,4]
C1276305
UMLS CUI [4,1]
C0278488
UMLS CUI [4,2]
C3900053
UMLS CUI [4,3]
C1522449
UMLS CUI [4,4]
C1276305
must have received any chemotherapy regimen in the past
Descrição

Prior Chemotherapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1514457
evidence of tumor resistance to last chemotherapy defined as progression after 6 months of previous chemotherapy for advanced disease
Descrição

Chemotherapy Refractory cancer Evidence of | Disease Progression Status post Prior Chemotherapy Advanced cancer

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0677936
UMLS CUI [1,3]
C0332120
UMLS CUI [2,1]
C0242656
UMLS CUI [2,2]
C0231290
UMLS CUI [2,3]
C1514457
UMLS CUI [2,4]
C0877373
must have measurable (by imaging techniques) disease
Descrição

Measurable Disease Imaging Techniques

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0079595
adequate bone marrow, liver and renal function
Descrição

Bone Marrow function | Liver function | Renal function

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
must provide evidence of informed consent and willingness and ability to comply with scheduled visits, treatment plan and study procedures.
Descrição

Informed Consent | Compliance behavior Study Protocol

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C2348563
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
received more than 2 prior chemotherapy regimens for metastatic disease
Descrição

Prior Chemotherapy Quantity Carcinoma breast stage IV

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0278488
received in the past another drug of the same class as the investigational drug, i.e. topoisomerase i inhibitor
Descrição

Pharmaceutical Preparation Class of Trial Agent Same | Topoisomerase I Inhibitors

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C2983595
UMLS CUI [1,3]
C0445247
UMLS CUI [2]
C0594374
enrolled in another clinical intervention study
Descrição

Study Subject Participation Status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
pregnancy, breast feeding, fertile women refusing to use reliable contraceptive methods
Descrição

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Refused

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C1705116
cardiac or thrombotic event in the last 12 months
Descrição

cardiac event | Thrombotic disorder

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0741923
UMLS CUI [2]
C0040053
brain metastases
Descrição

Metastatic malignant neoplasm to brain

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0220650
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Similar models

Eligibility Breast Neoplasms NCT00067314

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Locally advanced breast cancer Amenable Operative Surgical Procedures | Carcinoma breast stage IV Amenable Operative Surgical Procedures | Locally advanced breast cancer Amenable Therapeutic radiology procedure Curative | Carcinoma breast stage IV Amenable Therapeutic radiology procedure Curative
Item
locally advanced or metastatic breast cancer not amenable to surgery or radiation with curative intent
boolean
C3495949 (UMLS CUI [1,1])
C3900053 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
C0278488 (UMLS CUI [2,1])
C3900053 (UMLS CUI [2,2])
C0543467 (UMLS CUI [2,3])
C3495949 (UMLS CUI [3,1])
C3900053 (UMLS CUI [3,2])
C1522449 (UMLS CUI [3,3])
C1276305 (UMLS CUI [3,4])
C0278488 (UMLS CUI [4,1])
C3900053 (UMLS CUI [4,2])
C1522449 (UMLS CUI [4,3])
C1276305 (UMLS CUI [4,4])
Prior Chemotherapy
Item
must have received any chemotherapy regimen in the past
boolean
C1514457 (UMLS CUI [1])
Chemotherapy Refractory cancer Evidence of | Disease Progression Status post Prior Chemotherapy Advanced cancer
Item
evidence of tumor resistance to last chemotherapy defined as progression after 6 months of previous chemotherapy for advanced disease
boolean
C0392920 (UMLS CUI [1,1])
C0677936 (UMLS CUI [1,2])
C0332120 (UMLS CUI [1,3])
C0242656 (UMLS CUI [2,1])
C0231290 (UMLS CUI [2,2])
C1514457 (UMLS CUI [2,3])
C0877373 (UMLS CUI [2,4])
Measurable Disease Imaging Techniques
Item
must have measurable (by imaging techniques) disease
boolean
C1513041 (UMLS CUI [1,1])
C0079595 (UMLS CUI [1,2])
Bone Marrow function | Liver function | Renal function
Item
adequate bone marrow, liver and renal function
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Informed Consent | Compliance behavior Study Protocol
Item
must provide evidence of informed consent and willingness and ability to comply with scheduled visits, treatment plan and study procedures.
boolean
C0021430 (UMLS CUI [1])
C1321605 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Prior Chemotherapy Quantity Carcinoma breast stage IV
Item
received more than 2 prior chemotherapy regimens for metastatic disease
boolean
C1514457 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0278488 (UMLS CUI [1,3])
Pharmaceutical Preparation Class of Trial Agent Same | Topoisomerase I Inhibitors
Item
received in the past another drug of the same class as the investigational drug, i.e. topoisomerase i inhibitor
boolean
C0013227 (UMLS CUI [1,1])
C2983595 (UMLS CUI [1,2])
C0445247 (UMLS CUI [1,3])
C0594374 (UMLS CUI [2])
Study Subject Participation Status
Item
enrolled in another clinical intervention study
boolean
C2348568 (UMLS CUI [1])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Refused
Item
pregnancy, breast feeding, fertile women refusing to use reliable contraceptive methods
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C1705116 (UMLS CUI [3,3])
cardiac event | Thrombotic disorder
Item
cardiac or thrombotic event in the last 12 months
boolean
C0741923 (UMLS CUI [1])
C0040053 (UMLS CUI [2])
Metastatic malignant neoplasm to brain
Item
brain metastases
boolean
C0220650 (UMLS CUI [1])
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