ID

16213

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00081510

Nyckelord

Versioner (1)
  1. 2016-07-05 2016-07-05 -
Uppladdad den

5 juli 2016

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Breast Cancer NCT00081510

Engelsk

Eligibility Breast Cancer NCT00081510

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Postmenopausal state | Breast Carcinoma

Datatyp

boolean

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

Estrogen receptor positive | progesterone receptor positive

Datatyp

boolean

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

advanced disease Locally

Datatyp

boolean

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

Neoplasm Metastasis Distant

Datatyp

boolean

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

Therapeutic procedure Disease | Aromatase Inhibitors

Datatyp

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.
Beskrivning

Diphosphonates Intake

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

ECOG performance status

Datatyp

boolean

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

Bone Marrow Mature Neutrophils Sufficient

Datatyp

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.
Beskrivning

Liver function | Renal function | Normal Laboratory Test Result

Datatyp

boolean

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

Exclusion Criteria

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

Cytotoxic Chemotherapy advanced disease

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

Farnesyl Transferase Inhibitors

Datatyp

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).
Beskrivning

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

Datatyp

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
Tillbaka till toppen

Similar models

Eligibility Breast Cancer NCT00081510

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

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