ID

39871

Description

Efficacy and Safety Study of Trastuzumab and Paclitaxel Based Regimens to Treat HER2-positive Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01428414

Link

https://clinicaltrials.gov/show/NCT01428414

Keywords

  1. 2/25/20 2/25/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 25, 2020

DOI

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License

Creative Commons BY 4.0

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Eligibility HER-2 Positive Breast Cancer NCT01428414

Eligibility HER-2 Positive Breast Cancer NCT01428414

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. female patients, presenting for the first time with invasive breast cancer, who have not received any previous treatment for an invasive malignancy
Description

Gender | Invasive carcinoma of breast Firstly | Prior Therapy Absent Invasive cancer

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0853879
UMLS CUI [2,2]
C1279901
UMLS CUI [3,1]
C1514463
UMLS CUI [3,2]
C0332197
UMLS CUI [3,3]
C0677898
2. aged ≥18 years and < 70 years with life expectancy > 12 months
Description

Age | Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0023671
3. histologically confirmed invasive breast cancer (excluding inflammatory breast cancer) by core needle biopsy, staged ii-iii according to tnm classification system, with no evidence of metastasis and tumor size ≥3 cm
Description

Invasive carcinoma of breast TNM Breast tumor staging Core needle biopsy | Exception Inflammatory Breast Carcinoma | Neoplasm Metastasis Absent | Tumor size

Data type

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0474926
UMLS CUI [1,3]
C1318309
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0278601
UMLS CUI [3,1]
C0027627
UMLS CUI [3,2]
C0332197
UMLS CUI [4]
C0475440
4. her2 positive confirmed by ihc 2+ and fish positivity or ihc 3+
Description

HER2 Positive Immunohistochemistry | FISH Positive

Data type

boolean

Alias
UMLS CUI [1,1]
C2348909
UMLS CUI [1,2]
C0021044
UMLS CUI [2,1]
C0162789
UMLS CUI [2,2]
C1514241
5. at least one measurable lesion according to recist criteria 1.1
Description

Measurable lesion Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
6. patients with a left ventricular ejection fraction(lvef)≥55% by muga scan or echocardiography
Description

Left ventricular ejection fraction MUGA scan | Left ventricular ejection fraction Echocardiography

Data type

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0521317
UMLS CUI [2,1]
C0428772
UMLS CUI [2,2]
C0013516
7. ecog ps 0-1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
8. willing to take biopsy before surgery and during chemotherapy and willing to take pre-operative chemotherapy and related treatment
Description

Biopsy Before Operative Surgical Procedures | Biopsy During Chemotherapy | Chemotherapy Preoperative

Data type

boolean

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0543467
UMLS CUI [2,1]
C0005558
UMLS CUI [2,2]
C0347984
UMLS CUI [2,3]
C0392920
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C0445204
9. signed written informed consent; able to comply with the protocol
Description

Informed Consent | Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patient is pregnant or lactating.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
2. women of child-bearing potential must have a negative pregnancy test (urine or serum) within 7 days of drug administration and agree to take an adequate contraceptive measure
Description

Childbearing Potential Urine pregnancy test negative | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430057
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0430061
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
3. previous treatment with chemotherapy or hormonal therapy or any prior therapy with an anti-her2 therapy for any malignancy.
Description

Prior Chemotherapy | Prior Hormone Therapy | Cancer treatment Against HER2

Data type

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2]
C1514460
UMLS CUI [3,1]
C0920425
UMLS CUI [3,2]
C0521124
UMLS CUI [3,3]
C0069515
4. history of congestive heart failure, uncontrolled or symptomatic angina pectoris, arrhythmia or myocardial infarction
Description

Congestive heart failure | Angina Pectoris Uncontrolled | Angina Pectoris Symptomatic | Cardiac Arrhythmia | Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0018802
UMLS CUI [2,1]
C0002962
UMLS CUI [2,2]
C0205318
UMLS CUI [3,1]
C0002962
UMLS CUI [3,2]
C0231220
UMLS CUI [4]
C0003811
UMLS CUI [5]
C0027051
5. other invasive malignancy (including second primary breast cancer) which could affect compliance with the protocol or interpretation of results. patients who have been curatively treated and free of malignant disease for greater than 5 years are generally eligible
Description

Invasive cancer Affecting Protocol Compliance | Invasive cancer Affecting Interpretation Research results | Including Breast Carcinoma primary second | Exception Curative treatment Malignant disease | Exception Malignant disease Free Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0677898
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C0677898
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0459471
UMLS CUI [2,4]
C0683954
UMLS CUI [3,1]
C0332257
UMLS CUI [3,2]
C0678222
UMLS CUI [3,3]
C0205225
UMLS CUI [3,4]
C0205436
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1273390
UMLS CUI [4,3]
C0442867
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0442867
UMLS CUI [5,3]
C0332296
UMLS CUI [5,4]
C0449238
6. inadequate bone marrow, hepatic and renal functions as evidenced by the following:
Description

Bone Marrow function Inadequate | Liver function Inadequate | Renal function Inadequate

Data type

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [1,3]
C0205412
UMLS CUI [2,1]
C0232741
UMLS CUI [2,2]
C0205412
UMLS CUI [3,1]
C0232804
UMLS CUI [3,2]
C0205412
neutrophil count of <1500/ul,
Description

Neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0200633
platelet count of <100,000/ul.
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
haemoglobin <10 g/dl.
Description

Hemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0518015
serum total bilirubin > 1.5*uln (upper limit of normal),
Description

SERUM TOTAL BILIRUBIN ELEVATED

Data type

boolean

Alias
UMLS CUI [1]
C0595866
alt or ast > 2.5*uln,
Description

Alanine aminotransferase increased | Aspartate aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0151905
UMLS CUI [2]
C0151904
alkaline phosphatase > 2.5*uln,
Description

Alkaline phosphatase raised

Data type

boolean

Alias
UMLS CUI [1]
C0151849
serum creatinine > 1.5*uln.
Description

Serum creatinine raised

Data type

boolean

Alias
UMLS CUI [1]
C0700225
7. other serious illness or medical condition including:
Description

Illness Serious | Other medical condition Serious

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0205404
congestive heart failure (nyha class ii, iii, iv) or history of documented congestive heart failure, unstable angina pectoris, myocardial infarction in the last 6 months, clinically significant valvular heart disease, or high-risk uncontrolled arrhythmias.
Description

Congestive heart failure New York Heart Association Classification | Medical History Congestive heart failure | Angina, Unstable | Myocardial Infarction | Heart valve disease | High risk Cardiac Arrhythmia Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0018802
UMLS CUI [3]
C0002965
UMLS CUI [4]
C0027051
UMLS CUI [5]
C0018824
UMLS CUI [6,1]
C4319571
UMLS CUI [6,2]
C0003811
UMLS CUI [6,3]
C0205318
patients with dyspnoea at rest due to malignant or other disease (e.g. pulmonary metastases with lymphangitis) or who require supportive oxygen therapy.
Description

Resting Dyspnea Due to Malignant disease | Resting Dyspnea Due to Disease | Secondary malignant neoplasm of lung with Lymphangitis | Patient need for Oxygen therapy support

Data type

boolean

Alias
UMLS CUI [1,1]
C0743330
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0442867
UMLS CUI [2,1]
C0743330
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0012634
UMLS CUI [3,1]
C0153676
UMLS CUI [3,2]
C0332287
UMLS CUI [3,3]
C0024225
UMLS CUI [4,1]
C0686904
UMLS CUI [4,2]
C3872899
active serious uncontrolled infections.
Description

Communicable Diseases Serious Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0205318
poorly controlled diabetes mellitus.
Description

Poorly controlled diabetes mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0554876
8. not willing to take pre-operative biopsy or neo-adjuvant therapy
Description

Biopsy Preoperative Unwilling | Neoadjuvant Therapy Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C0445204
UMLS CUI [1,3]
C0558080
UMLS CUI [2,1]
C0600558
UMLS CUI [2,2]
C0558080
9. patients with psychiatric disorder or other disease leading to incompliance to the therapy
Description

Mental disorders Treatment Compliance Lacking | Other medical condition Treatment Compliance Lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C4319828
UMLS CUI [1,3]
C0332268
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C4319828
UMLS CUI [2,3]
C0332268
10. known hypersensitivity to any ingredient of the regimen
Description

Hypersensitivity Investigational Therapy Ingredient

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0949266
UMLS CUI [1,3]
C1550600
11. treatment with any investigational drug within 30 days before the beginning of treatment with study drug.
Description

Investigational New Drugs Recent

Data type

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0332185

Similar models

Eligibility HER-2 Positive Breast Cancer NCT01428414

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Invasive carcinoma of breast Firstly | Prior Therapy Absent Invasive cancer
Item
1. female patients, presenting for the first time with invasive breast cancer, who have not received any previous treatment for an invasive malignancy
boolean
C0079399 (UMLS CUI [1])
C0853879 (UMLS CUI [2,1])
C1279901 (UMLS CUI [2,2])
C1514463 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0677898 (UMLS CUI [3,3])
Age | Life Expectancy
Item
2. aged ≥18 years and < 70 years with life expectancy > 12 months
boolean
C0001779 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
Invasive carcinoma of breast TNM Breast tumor staging Core needle biopsy | Exception Inflammatory Breast Carcinoma | Neoplasm Metastasis Absent | Tumor size
Item
3. histologically confirmed invasive breast cancer (excluding inflammatory breast cancer) by core needle biopsy, staged ii-iii according to tnm classification system, with no evidence of metastasis and tumor size ≥3 cm
boolean
C0853879 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
C1318309 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0278601 (UMLS CUI [2,2])
C0027627 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0475440 (UMLS CUI [4])
HER2 Positive Immunohistochemistry | FISH Positive
Item
4. her2 positive confirmed by ihc 2+ and fish positivity or ihc 3+
boolean
C2348909 (UMLS CUI [1,1])
C0021044 (UMLS CUI [1,2])
C0162789 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
Measurable lesion Quantity
Item
5. at least one measurable lesion according to recist criteria 1.1
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Left ventricular ejection fraction MUGA scan | Left ventricular ejection fraction Echocardiography
Item
6. patients with a left ventricular ejection fraction(lvef)≥55% by muga scan or echocardiography
boolean
C0428772 (UMLS CUI [1,1])
C0521317 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2,1])
C0013516 (UMLS CUI [2,2])
ECOG performance status
Item
7. ecog ps 0-1
boolean
C1520224 (UMLS CUI [1])
Biopsy Before Operative Surgical Procedures | Biopsy During Chemotherapy | Chemotherapy Preoperative
Item
8. willing to take biopsy before surgery and during chemotherapy and willing to take pre-operative chemotherapy and related treatment
boolean
C0005558 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
C0005558 (UMLS CUI [2,1])
C0347984 (UMLS CUI [2,2])
C0392920 (UMLS CUI [2,3])
C0392920 (UMLS CUI [3,1])
C0445204 (UMLS CUI [3,2])
Informed Consent | Protocol Compliance
Item
9. signed written informed consent; able to comply with the protocol
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
1. patient is pregnant or lactating.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential Urine pregnancy test negative | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Contraceptive methods
Item
2. women of child-bearing potential must have a negative pregnancy test (urine or serum) within 7 days of drug administration and agree to take an adequate contraceptive measure
boolean
C3831118 (UMLS CUI [1,1])
C0430057 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430061 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Prior Chemotherapy | Prior Hormone Therapy | Cancer treatment Against HER2
Item
3. previous treatment with chemotherapy or hormonal therapy or any prior therapy with an anti-her2 therapy for any malignancy.
boolean
C1514457 (UMLS CUI [1])
C1514460 (UMLS CUI [2])
C0920425 (UMLS CUI [3,1])
C0521124 (UMLS CUI [3,2])
C0069515 (UMLS CUI [3,3])
Congestive heart failure | Angina Pectoris Uncontrolled | Angina Pectoris Symptomatic | Cardiac Arrhythmia | Myocardial Infarction
Item
4. history of congestive heart failure, uncontrolled or symptomatic angina pectoris, arrhythmia or myocardial infarction
boolean
C0018802 (UMLS CUI [1])
C0002962 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0002962 (UMLS CUI [3,1])
C0231220 (UMLS CUI [3,2])
C0003811 (UMLS CUI [4])
C0027051 (UMLS CUI [5])
Invasive cancer Affecting Protocol Compliance | Invasive cancer Affecting Interpretation Research results | Including Breast Carcinoma primary second | Exception Curative treatment Malignant disease | Exception Malignant disease Free Duration
Item
5. other invasive malignancy (including second primary breast cancer) which could affect compliance with the protocol or interpretation of results. patients who have been curatively treated and free of malignant disease for greater than 5 years are generally eligible
boolean
C0677898 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0677898 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0459471 (UMLS CUI [2,3])
C0683954 (UMLS CUI [2,4])
C0332257 (UMLS CUI [3,1])
C0678222 (UMLS CUI [3,2])
C0205225 (UMLS CUI [3,3])
C0205436 (UMLS CUI [3,4])
C1705847 (UMLS CUI [4,1])
C1273390 (UMLS CUI [4,2])
C0442867 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0442867 (UMLS CUI [5,2])
C0332296 (UMLS CUI [5,3])
C0449238 (UMLS CUI [5,4])
Bone Marrow function Inadequate | Liver function Inadequate | Renal function Inadequate
Item
6. inadequate bone marrow, hepatic and renal functions as evidenced by the following:
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0205412 (UMLS CUI [1,3])
C0232741 (UMLS CUI [2,1])
C0205412 (UMLS CUI [2,2])
C0232804 (UMLS CUI [3,1])
C0205412 (UMLS CUI [3,2])
Neutrophil count
Item
neutrophil count of <1500/ul,
boolean
C0200633 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count of <100,000/ul.
boolean
C0032181 (UMLS CUI [1])
Hemoglobin measurement
Item
haemoglobin <10 g/dl.
boolean
C0518015 (UMLS CUI [1])
SERUM TOTAL BILIRUBIN ELEVATED
Item
serum total bilirubin > 1.5*uln (upper limit of normal),
boolean
C0595866 (UMLS CUI [1])
Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
alt or ast > 2.5*uln,
boolean
C0151905 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
Alkaline phosphatase raised
Item
alkaline phosphatase > 2.5*uln,
boolean
C0151849 (UMLS CUI [1])
Serum creatinine raised
Item
serum creatinine > 1.5*uln.
boolean
C0700225 (UMLS CUI [1])
Illness Serious | Other medical condition Serious
Item
7. other serious illness or medical condition including:
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C3843040 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
Congestive heart failure New York Heart Association Classification | Medical History Congestive heart failure | Angina, Unstable | Myocardial Infarction | Heart valve disease | High risk Cardiac Arrhythmia Uncontrolled
Item
congestive heart failure (nyha class ii, iii, iv) or history of documented congestive heart failure, unstable angina pectoris, myocardial infarction in the last 6 months, clinically significant valvular heart disease, or high-risk uncontrolled arrhythmias.
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0018802 (UMLS CUI [2,2])
C0002965 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
C0018824 (UMLS CUI [5])
C4319571 (UMLS CUI [6,1])
C0003811 (UMLS CUI [6,2])
C0205318 (UMLS CUI [6,3])
Resting Dyspnea Due to Malignant disease | Resting Dyspnea Due to Disease | Secondary malignant neoplasm of lung with Lymphangitis | Patient need for Oxygen therapy support
Item
patients with dyspnoea at rest due to malignant or other disease (e.g. pulmonary metastases with lymphangitis) or who require supportive oxygen therapy.
boolean
C0743330 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0442867 (UMLS CUI [1,3])
C0743330 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0012634 (UMLS CUI [2,3])
C0153676 (UMLS CUI [3,1])
C0332287 (UMLS CUI [3,2])
C0024225 (UMLS CUI [3,3])
C0686904 (UMLS CUI [4,1])
C3872899 (UMLS CUI [4,2])
Communicable Diseases Serious Uncontrolled
Item
active serious uncontrolled infections.
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
Poorly controlled diabetes mellitus
Item
poorly controlled diabetes mellitus.
boolean
C0554876 (UMLS CUI [1])
Biopsy Preoperative Unwilling | Neoadjuvant Therapy Unwilling
Item
8. not willing to take pre-operative biopsy or neo-adjuvant therapy
boolean
C0005558 (UMLS CUI [1,1])
C0445204 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C0600558 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Mental disorders Treatment Compliance Lacking | Other medical condition Treatment Compliance Lacking
Item
9. patients with psychiatric disorder or other disease leading to incompliance to the therapy
boolean
C0004936 (UMLS CUI [1,1])
C4319828 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C4319828 (UMLS CUI [2,2])
C0332268 (UMLS CUI [2,3])
Hypersensitivity Investigational Therapy Ingredient
Item
10. known hypersensitivity to any ingredient of the regimen
boolean
C0020517 (UMLS CUI [1,1])
C0949266 (UMLS CUI [1,2])
C1550600 (UMLS CUI [1,3])
Investigational New Drugs Recent
Item
11. treatment with any investigational drug within 30 days before the beginning of treatment with study drug.
boolean
C0013230 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])

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