ID

43819

Description

Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Older Patients With Locally Advanced or Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01463072

Link

https://clinicaltrials.gov/show/NCT01463072

Keywords

Versions (2)
  1. 3/13/16 3/13/16 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Male Breast Cancer NCT01463072

English

Eligibility Male Breast Cancer NCT01463072

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
locally advanced or metastatic breast cancer
Description

metastatic breast cancer

Data type

boolean

Alias
UMLS CUI [1]
C0278488
any estrogen receptor (er), progesterone receptor (pr), or human epidermal growth factor receptor 2 (her2neu) status as long as the patient will receive nab-paclitaxel alone
Description

estrogen receptor; progesterone receptor ; human epidermal growth factor receptor 2

Data type

boolean

Alias
UMLS CUI [1]
C0034804
UMLS CUI [2]
C0034833
UMLS CUI [3]
C3496586
first or second line chemotherapy treatment for metastatic disease
Description

chemotherapy metastatic disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0027627
karnofsky performance scale (kps) >= 70%
Description

karnofsky performance scale

Data type

boolean

Alias
UMLS CUI [1]
C0206065
resolution of grade >= 2 toxicity from prior therapy (other than alopecia)
Description

toxicity alopecia

Data type

boolean

Alias
UMLS CUI [1,1]
C0013221
UMLS CUI [1,2]
C0002170
peripheral neuropathy =< grade 1
Description

peripheral neuropathy

Data type

boolean

Alias
UMLS CUI [1]
C0031117
absolute neutrophil count >= 1,500/mm^3
Description

absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0948762
platelets >= 100,000 cells/mm^3
Description

platelets

Data type

boolean

Alias
UMLS CUI [1]
C0005821
hemoglobin (hb) >= 9.0 g/dl
Description

hemoglobin

Data type

boolean

Alias
UMLS CUI [1]
C0518015
aspartate aminotransferase (ast) and alanine aminotransferase (alt) =< 2.5 x institutional upper limit of normal
Description

Aspartate aminotransferase/Alanine aminotransferase

Data type

boolean

Alias
UMLS CUI [1]
C0805162
alkaline phosphatase =< 2.5 x upper limit of normal unless bone metastasis are present in the absence of liver metastases
Description

alkaline phosphatase

Data type

boolean

Alias
UMLS CUI [1]
C0201850
bilirubin =< 1.5 mg/dl
Description

bilirubin

Data type

boolean

Alias
UMLS CUI [1]
C0005437
creatinine clearance (calculated or 24 hour) >= 30 ml/min
Description

creatinine clearance

Data type

boolean

Alias
UMLS CUI [1]
C0373595
ability to understand and the willingness to sign a written informed consent document
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients may not be receiving any other investigational agents
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
untreated central nervous system (cns) metastases or symptomatic cns metastases requiring escalating doses of corticosteroids
Description

CNS metastases; dosage corticosteroids

Data type

boolean

Alias
UMLS CUI [1]
C0686377
UMLS CUI [2,1]
C0178602
UMLS CUI [2,2]
C0001617
known history of allergic reactions to paclitaxel
Description

hypersensitivity paclitaxel

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0144576
presence of any serious or uncontrolled infection
Description

infection

Data type

boolean

Alias
UMLS CUI [1]
C0009450
receipt of a taxane for adjuvant therapy or metastatic disease in the last 12 months
Description

adjuvant therapy taxane

Data type

boolean

Alias
UMLS CUI [1,1]
C0677850
UMLS CUI [1,2]
C0215136
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Similar models

Eligibility Male Breast Cancer NCT01463072

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
metastatic breast cancer
Item
locally advanced or metastatic breast cancer
boolean
C0278488 (UMLS CUI [1])
estrogen receptor; progesterone receptor ; human epidermal growth factor receptor 2
Item
any estrogen receptor (er), progesterone receptor (pr), or human epidermal growth factor receptor 2 (her2neu) status as long as the patient will receive nab-paclitaxel alone
boolean
C0034804 (UMLS CUI [1])
C0034833 (UMLS CUI [2])
C3496586 (UMLS CUI [3])
chemotherapy metastatic disease
Item
first or second line chemotherapy treatment for metastatic disease
boolean
C0392920 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
karnofsky performance scale
Item
karnofsky performance scale (kps) >= 70%
boolean
C0206065 (UMLS CUI [1])
toxicity alopecia
Item
resolution of grade >= 2 toxicity from prior therapy (other than alopecia)
boolean
C0013221 (UMLS CUI [1,1])
C0002170 (UMLS CUI [1,2])
peripheral neuropathy
Item
peripheral neuropathy =< grade 1
boolean
C0031117 (UMLS CUI [1])
absolute neutrophil count
Item
absolute neutrophil count >= 1,500/mm^3
boolean
C0948762 (UMLS CUI [1])
platelets
Item
platelets >= 100,000 cells/mm^3
boolean
C0005821 (UMLS CUI [1])
hemoglobin
Item
hemoglobin (hb) >= 9.0 g/dl
boolean
C0518015 (UMLS CUI [1])
Aspartate aminotransferase/Alanine aminotransferase
Item
aspartate aminotransferase (ast) and alanine aminotransferase (alt) =< 2.5 x institutional upper limit of normal
boolean
C0805162 (UMLS CUI [1])
alkaline phosphatase
Item
alkaline phosphatase =< 2.5 x upper limit of normal unless bone metastasis are present in the absence of liver metastases
boolean
C0201850 (UMLS CUI [1])
bilirubin
Item
bilirubin =< 1.5 mg/dl
boolean
C0005437 (UMLS CUI [1])
creatinine clearance
Item
creatinine clearance (calculated or 24 hour) >= 30 ml/min
boolean
C0373595 (UMLS CUI [1])
informed consent
Item
ability to understand and the willingness to sign a written informed consent document
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status
Item
patients may not be receiving any other investigational agents
boolean
C2348568 (UMLS CUI [1])
CNS metastases; dosage corticosteroids
Item
untreated central nervous system (cns) metastases or symptomatic cns metastases requiring escalating doses of corticosteroids
boolean
C0686377 (UMLS CUI [1])
C0178602 (UMLS CUI [2,1])
C0001617 (UMLS CUI [2,2])
hypersensitivity paclitaxel
Item
known history of allergic reactions to paclitaxel
boolean
C0020517 (UMLS CUI [1,1])
C0144576 (UMLS CUI [1,2])
infection
Item
presence of any serious or uncontrolled infection
boolean
C0009450 (UMLS CUI [1])
adjuvant therapy taxane
Item
receipt of a taxane for adjuvant therapy or metastatic disease in the last 12 months
boolean
C0677850 (UMLS CUI [1,1])
C0215136 (UMLS CUI [1,2])
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