ID

16303

Description

PTK787 + Trastuzumab for HER2 Overexpressing Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00216047

Link

https://clinicaltrials.gov/show/NCT00216047

Keywords

Versions (1)
  1. 7/10/16 7/10/16 -
Uploaded on

July 10, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00216047

English

Eligibility Breast Cancer NCT00216047

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologic or cytologic diagnosis of breast cancer with evidence of measurable (1) unresectable, locally recurrent, or (2) metastatic disease. locally recurrent disease must not be amenable to resection or radiation with curative intent.
Description

breast cancer with evidence of measurable (1) unresectable, locally recurrent, or (2) metastatic disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C1336869
UMLS CUI [1,3]
C1458156
UMLS CUI [2]
C0278488
patient's disease may not involve more than 3 metastatic sites. in addition, patient may not be symptomatic from pulmonary metastasis or have liver metastasis involving > 50% of parenchyma.
Description

number of metastatic sites, pulmonary metastasis or liver metastasis involving 50 percent of parenchyma

Data type

boolean

Alias
UMLS CUI [1]
C0280457
UMLS CUI [2]
C0153676
UMLS CUI [3]
C0494165
her2 gene amplification by fish. her protein overexpression by immunohistochemistry will not be sufficient for entry.
Description

her2 gene amplification by fish

Data type

boolean

Alias
UMLS CUI [1,1]
C1512127
UMLS CUI [1,2]
C0162789
negative pregnancy test
Description

pregnancy test

Data type

boolean

Alias
UMLS CUI [1]
C0032976
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
no prior cytotoxic chemotherapy or trastuzumab for locally recurrent or metastatic disease.
Description

prior cytotoxic chemotherapy or trastuzumab

Data type

boolean

Alias
UMLS CUI [1]
C0677881
UMLS CUI [2]
C0728747
no prior treatment with any vegf inhibiting agents
Description

prior treatment with any vegf inhibiting agents

Data type

boolean

Alias
UMLS CUI [1]
C0596087
no history or presence of central nervous system (cns) disease.
Description

central nervous system disease

Data type

boolean

Alias
UMLS CUI [1]
C0007682
no other forms of cancer therapy including radiation, chemotherapy and hormonal therapy within 21 days prior to being registered for protocol therapy.
Description

Cancer Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0920425
no major surgery within 28 days prior to being registered for protocol therapy.
Description

Surgery

Data type

boolean

Alias
UMLS CUI [1]
C0543467
no uncontrolled hypertension (sbp > 170, dbp > 90), history of labile hypertension or history of poor compliance with antihypertensive therapy.
Description

Hypertension

Data type

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C0005823
no requirement for therapeutic anticoagulation, regular aspirin (> 325 mg/day) or nsaid use.
Description

Anticoagulation therapy

Data type

boolean

Alias
UMLS CUI [1]
C0003281
no current breast feeding.
Description

breast feeding

Data type

boolean

Alias
UMLS CUI [1]
C0006147
no impairment of gastrointestinal (gi) function that may significantly alter the absorption of ptk787.
Description

Impairment of gastrointestinal function

Data type

boolean

Alias
UMLS CUI [1,1]
C0232459
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0021826
no evidence of other serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator).
Description

Other serious concomitant systemic disorders

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
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Similar models

Eligibility Breast Cancer NCT00216047

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
breast cancer with evidence of measurable (1) unresectable, locally recurrent, or (2) metastatic disease
Item
histologic or cytologic diagnosis of breast cancer with evidence of measurable (1) unresectable, locally recurrent, or (2) metastatic disease. locally recurrent disease must not be amenable to resection or radiation with curative intent.
boolean
C0678222 (UMLS CUI [1,1])
C1336869 (UMLS CUI [1,2])
C1458156 (UMLS CUI [1,3])
C0278488 (UMLS CUI [2])
number of metastatic sites, pulmonary metastasis or liver metastasis involving 50 percent of parenchyma
Item
patient's disease may not involve more than 3 metastatic sites. in addition, patient may not be symptomatic from pulmonary metastasis or have liver metastasis involving > 50% of parenchyma.
boolean
C0280457 (UMLS CUI [1])
C0153676 (UMLS CUI [2])
C0494165 (UMLS CUI [3])
her2 gene amplification by fish
Item
her2 gene amplification by fish. her protein overexpression by immunohistochemistry will not be sufficient for entry.
boolean
C1512127 (UMLS CUI [1,1])
C0162789 (UMLS CUI [1,2])
pregnancy test
Item
negative pregnancy test
boolean
C0032976 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
prior cytotoxic chemotherapy or trastuzumab
Item
no prior cytotoxic chemotherapy or trastuzumab for locally recurrent or metastatic disease.
boolean
C0677881 (UMLS CUI [1])
C0728747 (UMLS CUI [2])
prior treatment with any vegf inhibiting agents
Item
no prior treatment with any vegf inhibiting agents
boolean
C0596087 (UMLS CUI [1])
central nervous system disease
Item
no history or presence of central nervous system (cns) disease.
boolean
C0007682 (UMLS CUI [1])
Cancer Therapy
Item
no other forms of cancer therapy including radiation, chemotherapy and hormonal therapy within 21 days prior to being registered for protocol therapy.
boolean
C0920425 (UMLS CUI [1])
Surgery
Item
no major surgery within 28 days prior to being registered for protocol therapy.
boolean
C0543467 (UMLS CUI [1])
Hypertension
Item
no uncontrolled hypertension (sbp > 170, dbp > 90), history of labile hypertension or history of poor compliance with antihypertensive therapy.
boolean
C0020538 (UMLS CUI [1,1])
C0005823 (UMLS CUI [1,2])
Anticoagulation therapy
Item
no requirement for therapeutic anticoagulation, regular aspirin (> 325 mg/day) or nsaid use.
boolean
C0003281 (UMLS CUI [1])
breast feeding
Item
no current breast feeding.
boolean
C0006147 (UMLS CUI [1])
Impairment of gastrointestinal function
Item
no impairment of gastrointestinal (gi) function that may significantly alter the absorption of ptk787.
boolean
C0232459 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0021826 (UMLS CUI [1,3])
Other serious concomitant systemic disorders
Item
no evidence of other serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator).
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
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