ID

16213

Beschrijving

Anastrozole Plus Lonafarnib (SCH 66336) or Plus Placebo for the Treatment of Advanced Breast Cancer (P03480); ODM derived from: https://clinicaltrials.gov/show/NCT00081510

Link

https://clinicaltrials.gov/show/NCT00081510

Trefwoorden

Versies (1)
  1. 05-07-16 05-07-16 -
Geüploaded op

5 juli 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00081510

Engels

Eligibility Breast Cancer NCT00081510

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
postmenopausal women who have histologically-confirmed breast cancer with the following characteristics:
Beschrijving

Postmenopausal state | Breast Carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0678222
estrogen and/or progesterone receptor positive,
Beschrijving

Estrogen receptor positive | progesterone receptor positive

Datatype

boolean

Alias
UMLS CUI [1]
C0279754
UMLS CUI [2]
C0279759
locally advanced disease
Beschrijving

advanced disease Locally

Datatype

boolean

Alias
UMLS CUI [1,1]
C0679246
UMLS CUI [1,2]
C1517927
distant metastatic disease, stage 4
Beschrijving

Neoplasm Metastasis Distant

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0443203
subjects eligible for single-agent treatment with aromatase inhibitors for current disease.
Beschrijving

Therapeutic procedure Disease | Aromatase Inhibitors

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0012634
UMLS CUI [2]
C0593802
subjects taking biophosphonates are allowed if they begin bisphosphonate therapy at least two weeks prior to randomization.
Beschrijving

Diphosphonates Intake

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012544
UMLS CUI [1,2]
C1512806
measurable disease (masses with clearly defined margins on radiological images and at least one diameter >=20 mm[>=10 mm if spiral ct]) or evaluable disease (masses with margins not clearly defined on radiological images or with no diameter >= 20 mm). subjects with bone disease only are permitted if disease is evaluable.
Beschrijving

Measurable Disease | Mass in breast Diameter | Tumor margin status | Diagnostic Imaging | Tomography, Spiral Computed | Evaluable Disease | Bone Diseases

Datatype

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2,1]
C0024103
UMLS CUI [2,2]
C1301886
UMLS CUI [3]
C1269830
UMLS CUI [4]
C0011923
UMLS CUI [5]
C0860888
UMLS CUI [6]
C1516986
UMLS CUI [7]
C0005940
ecog performance status of 0 or 1.
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
sufficient bone marrow reserve.
Beschrijving

Bone Marrow Mature Neutrophils Sufficient

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C1708947
UMLS CUI [1,3]
C0205410
adequate hepatic and renal function: laboratory values within protocol requirements.
Beschrijving

Liver function | Renal function | Normal Laboratory Test Result

Datatype

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0438214
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects who have received more than one regimen of cytotoxic chemotherapy for advanced disease.
Beschrijving

Cytotoxic Chemotherapy advanced disease

Datatype

boolean

Alias
UMLS CUI [1,1]
C0677881
UMLS CUI [1,2]
C0679246
subjects with with clinically apparent brain metastases or extensive visceral disease, including extensive hepatic involvement or pulmonary lymphangitic spread of tumor.
Beschrijving

Metastatic malignant neoplasm to brain | Disease Visceral Extensive | Hepatic Involvement Extensive | Malignant Neoplasm pulmonary Lymphangitic spread

Datatype

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0442045
UMLS CUI [2,3]
C0205231
UMLS CUI [3,1]
C0441932
UMLS CUI [3,2]
C0205231
UMLS CUI [4,1]
C0006826
UMLS CUI [4,2]
C0024109
UMLS CUI [4,3]
C3697833
subjects with prior treatments with ftis.
Beschrijving

Farnesyl Transferase Inhibitors

Datatype

boolean

Alias
UMLS CUI [1]
C1517132
subjects with a known or suspected hypersensitivity to any excipients in the lonafarnib formulation (providone, poloxamer 188, croscarmellose sodium, silicon dioxide, and magnesium stearate).
Beschrijving

Hypersensitivity lonafarnib Pharmaceutical Excipient | Hypersensitivity Povidone | Hypersensitivity Poloxamer 188 | Hypersensitivity Croscarmellose Sodium | Hypersensitivity Silicon Dioxide | Hypersensitivity Magnesium stearate

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1257385
UMLS CUI [1,3]
C0015237
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0032856
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0600611
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0010353
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0037098
UMLS CUI [6,1]
C0020517
UMLS CUI [6,2]
C0126791
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Similar models

Eligibility Breast Cancer NCT00081510

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Postmenopausal state | Breast Carcinoma
Item
postmenopausal women who have histologically-confirmed breast cancer with the following characteristics:
boolean
C0232970 (UMLS CUI [1])
C0678222 (UMLS CUI [2])
Estrogen receptor positive | progesterone receptor positive
Item
estrogen and/or progesterone receptor positive,
boolean
C0279754 (UMLS CUI [1])
C0279759 (UMLS CUI [2])
advanced disease Locally
Item
locally advanced disease
boolean
C0679246 (UMLS CUI [1,1])
C1517927 (UMLS CUI [1,2])
Neoplasm Metastasis Distant
Item
distant metastatic disease, stage 4
boolean
C0027627 (UMLS CUI [1,1])
C0443203 (UMLS CUI [1,2])
Therapeutic procedure Disease | Aromatase Inhibitors
Item
subjects eligible for single-agent treatment with aromatase inhibitors for current disease.
boolean
C0087111 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0593802 (UMLS CUI [2])
Diphosphonates Intake
Item
subjects taking biophosphonates are allowed if they begin bisphosphonate therapy at least two weeks prior to randomization.
boolean
C0012544 (UMLS CUI [1,1])
C1512806 (UMLS CUI [1,2])
Measurable Disease | Mass in breast Diameter | Tumor margin status | Diagnostic Imaging | Tomography, Spiral Computed | Evaluable Disease | Bone Diseases
Item
measurable disease (masses with clearly defined margins on radiological images and at least one diameter >=20 mm[>=10 mm if spiral ct]) or evaluable disease (masses with margins not clearly defined on radiological images or with no diameter >= 20 mm). subjects with bone disease only are permitted if disease is evaluable.
boolean
C1513041 (UMLS CUI [1])
C0024103 (UMLS CUI [2,1])
C1301886 (UMLS CUI [2,2])
C1269830 (UMLS CUI [3])
C0011923 (UMLS CUI [4])
C0860888 (UMLS CUI [5])
C1516986 (UMLS CUI [6])
C0005940 (UMLS CUI [7])
ECOG performance status
Item
ecog performance status of 0 or 1.
boolean
C1520224 (UMLS CUI [1])
Bone Marrow Mature Neutrophils Sufficient
Item
sufficient bone marrow reserve.
boolean
C0005953 (UMLS CUI [1,1])
C1708947 (UMLS CUI [1,2])
C0205410 (UMLS CUI [1,3])
Liver function | Renal function | Normal Laboratory Test Result
Item
adequate hepatic and renal function: laboratory values within protocol requirements.
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0438214 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Cytotoxic Chemotherapy advanced disease
Item
subjects who have received more than one regimen of cytotoxic chemotherapy for advanced disease.
boolean
C0677881 (UMLS CUI [1,1])
C0679246 (UMLS CUI [1,2])
Metastatic malignant neoplasm to brain | Disease Visceral Extensive | Hepatic Involvement Extensive | Malignant Neoplasm pulmonary Lymphangitic spread
Item
subjects with with clinically apparent brain metastases or extensive visceral disease, including extensive hepatic involvement or pulmonary lymphangitic spread of tumor.
boolean
C0220650 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0442045 (UMLS CUI [2,2])
C0205231 (UMLS CUI [2,3])
C0441932 (UMLS CUI [3,1])
C0205231 (UMLS CUI [3,2])
C0006826 (UMLS CUI [4,1])
C0024109 (UMLS CUI [4,2])
C3697833 (UMLS CUI [4,3])
Farnesyl Transferase Inhibitors
Item
subjects with prior treatments with ftis.
boolean
C1517132 (UMLS CUI [1])
Hypersensitivity lonafarnib Pharmaceutical Excipient | Hypersensitivity Povidone | Hypersensitivity Poloxamer 188 | Hypersensitivity Croscarmellose Sodium | Hypersensitivity Silicon Dioxide | Hypersensitivity Magnesium stearate
Item
subjects with a known or suspected hypersensitivity to any excipients in the lonafarnib formulation (providone, poloxamer 188, croscarmellose sodium, silicon dioxide, and magnesium stearate).
boolean
C0020517 (UMLS CUI [1,1])
C1257385 (UMLS CUI [1,2])
C0015237 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0032856 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0600611 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0010353 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C0037098 (UMLS CUI [5,2])
C0020517 (UMLS CUI [6,1])
C0126791 (UMLS CUI [6,2])
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