ID

26060

Description

Phase II Trial of Neoadjuvant Metronomic Chemotherapy in Triple-Negative Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00542191

Link

https://clinicaltrials.gov/show/NCT00542191

Keywords

Versions (1)
  1. 10/5/17 10/5/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 5, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00542191

English

Eligibility Breast Cancer NCT00542191

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
women with estrogen receptor (er), progesterone receptor (pr),and her2 negative invasive breast cancer confirmed on core biopsy.(note: her2 negative by fish preferred; her2 0 or 1+ by ihc acceptable)
Description

Gender | Triple Negative Breast Neoplasms Core biopsy | HER2 negative FISH | HER2 negative Immunohistochemistry

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C3539878
UMLS CUI [2,2]
C1318309
UMLS CUI [3,1]
C4087376
UMLS CUI [3,2]
C0162789
UMLS CUI [4,1]
C4087376
UMLS CUI [4,2]
C0021044
primary tumor size 2cm or greater by physical exam or radiographic measurements.(note: locally advanced t4 or inflammatory breast cancer is eligible.)
Description

Primary tumor size Physical Examination | Primary tumor size Radiography | TNM clinical staging Advanced Locally | Inflammatory Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C1302656
UMLS CUI [1,2]
C0031809
UMLS CUI [2,1]
C1302656
UMLS CUI [2,2]
C0034571
UMLS CUI [3,1]
C3258246
UMLS CUI [3,2]
C0205179
UMLS CUI [3,3]
C1517927
UMLS CUI [4]
C0278601
assessment of pre-treatment axillary lymph nodal status (note: fna biopsy if palpable or sentinel lymph node biopsy (slnb) if not palpable preferred; clinical exam acceptable.)
Description

Assessment Axillary lymph node Status pre treatment | Lymph node palpable Fine needle aspiration biopsy | Lymph node palpable Absent Sentinel Lymph Node Biopsy | Clinical examination

Data type

boolean

Alias
UMLS CUI [1,1]
C1516048
UMLS CUI [1,2]
C0729594
UMLS CUI [1,3]
C0449438
UMLS CUI [1,4]
C2709094
UMLS CUI [2,1]
C1112395
UMLS CUI [2,2]
C1510483
UMLS CUI [3,1]
C1112395
UMLS CUI [3,2]
C0332197
UMLS CUI [3,3]
C0796693
UMLS CUI [4]
C1456356
absolute neutrophil count > 1500 mm3 and platelet count > 100,000 mm3
Description

Absolute neutrophil count | Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
normal myocardial left ventricular function
Description

Left ventricular ejection fraction Normal

Data type

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0205307
serum creatinine < 2.0 mg/dl
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
total bilirubin and ast < 3x upper limits normal
Description

Serum total bilirubin measurement | Aspartate aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201899
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
recurrent or metastatic breast cancer findings (note: if oncologically felt to be a second breast primary, patient eligible for this protocol)
Description

Breast cancer recurrent | Secondary malignant neoplasm of female breast

Data type

boolean

Alias
UMLS CUI [1]
C0278493
UMLS CUI [2]
C0346993
another active cancer present
Description

Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0006826
medical contraindications to chemotherapy or surgery
Description

Medical contraindication Chemotherapy | Medical contraindication Operative Surgical Procedures

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0392920
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0543467
first trimester pregnancy
Description

Pregnancy Trimester, First

Data type

boolean

Alias
UMLS CUI [1]
C0032979
breast feeding
Description

Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0006147
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Similar models

Eligibility Breast Cancer NCT00542191

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Triple Negative Breast Neoplasms Core biopsy | HER2 negative FISH | HER2 negative Immunohistochemistry
Item
women with estrogen receptor (er), progesterone receptor (pr),and her2 negative invasive breast cancer confirmed on core biopsy.(note: her2 negative by fish preferred; her2 0 or 1+ by ihc acceptable)
boolean
C0079399 (UMLS CUI [1])
C3539878 (UMLS CUI [2,1])
C1318309 (UMLS CUI [2,2])
C4087376 (UMLS CUI [3,1])
C0162789 (UMLS CUI [3,2])
C4087376 (UMLS CUI [4,1])
C0021044 (UMLS CUI [4,2])
Primary tumor size Physical Examination | Primary tumor size Radiography | TNM clinical staging Advanced Locally | Inflammatory Breast Carcinoma
Item
primary tumor size 2cm or greater by physical exam or radiographic measurements.(note: locally advanced t4 or inflammatory breast cancer is eligible.)
boolean
C1302656 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C1302656 (UMLS CUI [2,1])
C0034571 (UMLS CUI [2,2])
C3258246 (UMLS CUI [3,1])
C0205179 (UMLS CUI [3,2])
C1517927 (UMLS CUI [3,3])
C0278601 (UMLS CUI [4])
Assessment Axillary lymph node Status pre treatment | Lymph node palpable Fine needle aspiration biopsy | Lymph node palpable Absent Sentinel Lymph Node Biopsy | Clinical examination
Item
assessment of pre-treatment axillary lymph nodal status (note: fna biopsy if palpable or sentinel lymph node biopsy (slnb) if not palpable preferred; clinical exam acceptable.)
boolean
C1516048 (UMLS CUI [1,1])
C0729594 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
C2709094 (UMLS CUI [1,4])
C1112395 (UMLS CUI [2,1])
C1510483 (UMLS CUI [2,2])
C1112395 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0796693 (UMLS CUI [3,3])
C1456356 (UMLS CUI [4])
Absolute neutrophil count | Platelet Count measurement
Item
absolute neutrophil count > 1500 mm3 and platelet count > 100,000 mm3
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
Left ventricular ejection fraction Normal
Item
normal myocardial left ventricular function
boolean
C0428772 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
Creatinine measurement, serum
Item
serum creatinine < 2.0 mg/dl
boolean
C0201976 (UMLS CUI [1])
Serum total bilirubin measurement | Aspartate aminotransferase measurement
Item
total bilirubin and ast < 3x upper limits normal
boolean
C1278039 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Breast cancer recurrent | Secondary malignant neoplasm of female breast
Item
recurrent or metastatic breast cancer findings (note: if oncologically felt to be a second breast primary, patient eligible for this protocol)
boolean
C0278493 (UMLS CUI [1])
C0346993 (UMLS CUI [2])
Malignant Neoplasms
Item
another active cancer present
boolean
C0006826 (UMLS CUI [1])
Medical contraindication Chemotherapy | Medical contraindication Operative Surgical Procedures
Item
medical contraindications to chemotherapy or surgery
boolean
C1301624 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0543467 (UMLS CUI [2,2])
Pregnancy Trimester, First
Item
first trimester pregnancy
boolean
C0032979 (UMLS CUI [1])
Breast Feeding
Item
breast feeding
boolean
C0006147 (UMLS CUI [1])
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