ID

37762

Beskrivning

Neoadjuvant Treatment of Docetaxel, Anthracycline and Cyclophosphamide (TAC) Versus Docetaxel and Cyclophosphamide (TC) in Triple-Negative or Her2 Positive Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00912444

Länk

https://clinicaltrials.gov/show/NCT00912444

Nyckelord

Versioner (1)
  1. 2019-08-22 2019-08-22 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

22 augusti 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00912444

Engelsk

Eligibility Breast Cancer NCT00912444

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
women aged ≥ 18 years and < 70 years
Beskrivning

Gender | Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
karnofsky performance status (kps) ≥ 70
Beskrivning

Karnofsky Performance Status

Datatyp

boolean

Alias
UMLS CUI [1]
C0206065
at least one measurable disease according to the recist. histologically confirmed invasive breast cancer (excluding inflammatory breast cancer), t2n1 or locally advanced breast cancer (t3-4n0-3 or t0-4n2-3)
Beskrivning

Measurable Disease Quantity | Invasive carcinoma of breast | Exception Inflammatory Breast Carcinoma | Breast Carcinoma TNM Breast tumor staging | Locally advanced breast cancer TNM Breast tumor staging

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
UMLS CUI [2]
C0853879
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0278601
UMLS CUI [4,1]
C0678222
UMLS CUI [4,2]
C0474926
UMLS CUI [5,1]
C3495949
UMLS CUI [5,2]
C0474926
biopsy specimens are available for er, pgr and her2 detection, patients should be with triple negative or her2 positive breast cancer, her2 positivity is defined as fish/cish her2 positive or ihc her2 3+, triple-negative disease defined as negativity for er, pgr and her2
Beskrivning

Biopsy sample Estrogen Receptor Detection | Biopsy sample Progesterone Receptor Detection | Biopsy sample HER2 Detection | Triple Negative Breast Neoplasms | HER2-positive carcinoma of breast | HER2 Positive FISH | HER2 Positive CISH | HER2 Positive Immunohistochemistry

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0677862
UMLS CUI [1,2]
C0034804
UMLS CUI [1,3]
C1511790
UMLS CUI [2,1]
C0677862
UMLS CUI [2,2]
C0034833
UMLS CUI [2,3]
C1511790
UMLS CUI [3,1]
C0677862
UMLS CUI [3,2]
C0242957
UMLS CUI [3,3]
C1511790
UMLS CUI [4]
C3539878
UMLS CUI [5]
C1960398
UMLS CUI [6,1]
C2348909
UMLS CUI [6,2]
C0162789
UMLS CUI [7,1]
C2348909
UMLS CUI [7,2]
C1516514
UMLS CUI [8,1]
C2348909
UMLS CUI [8,2]
C0021044
adequate bone marrow function: neutrophil ≥ 1.5*109/l; hb ≥ 100g/l; plt ≥ 100*109/l
Beskrivning

Bone Marrow function | Neutrophil count | Hemoglobin measurement | Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0200633
UMLS CUI [3]
C0518015
UMLS CUI [4]
C0032181
an estimated life expectancy of at least 12 months
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
willing to take biopsy before neoadjuvant chemotherapy and patients must be accessible for treatment and follow-up
Beskrivning

Biopsy | Neoadjuvant Chemotherapy | Patients Available Treatment | Patients Available Follow-up

Datatyp

boolean

Alias
UMLS CUI [1]
C0005558
UMLS CUI [2,1]
C0600558
UMLS CUI [2,2]
C3665472
UMLS CUI [3,1]
C0030705
UMLS CUI [3,2]
C0470187
UMLS CUI [3,3]
C0087111
UMLS CUI [4,1]
C0030705
UMLS CUI [4,2]
C0470187
UMLS CUI [4,3]
C3274571
women with potential child-bearing must have a negative pregnancy test (urine or serum) within 7 days of drug administration and agree to use an acceptable method of birth control to avoid pregnancy for the duration of the study
Beskrivning

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

Datatyp

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
written informed consent according to the gcp
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior systemic or loco-regional treatment of breast cancer, including chemotherapy
Beskrivning

Systemic therapy Breast Carcinoma | Therapy Local-Regional Breast Carcinoma | Chemotherapy Breast Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0678222
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1947913
UMLS CUI [2,3]
C0678222
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C0678222
metastatic breast cancer
Beskrivning

Secondary malignant neoplasm of female breast

Datatyp

boolean

Alias
UMLS CUI [1]
C0346993
with a history of malignant tumor except uterine cervix cancer in situ or skin basal cell carcinoma
Beskrivning

Malignant Neoplasms | Exception Carcinoma in situ of uterine cervix | Exception Basal cell carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0851140
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
patients with medical conditions that indicate intolerant to neoadjuvant therapy and related treatment, including uncontrolled pulmonary disease, diabetes mellitis, severe infection, active peptic ulcer, coagulation disorder, connective tissue disease or myelo-suppressive disease
Beskrivning

Medical condition intolerant Neoadjuvant Therapy | Medical condition intolerant Therapeutic procedure Similar | Lung disease Uncontrolled | Diabetes Mellitus | Communicable Disease Severe | Peptic Ulcer | Blood Coagulation Disorder | Connective Tissue Disease | Myelosuppression adult

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0231200
UMLS CUI [1,3]
C0600558
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0231200
UMLS CUI [2,3]
C0087111
UMLS CUI [2,4]
C2348205
UMLS CUI [3,1]
C0024115
UMLS CUI [3,2]
C0205318
UMLS CUI [4]
C0011849
UMLS CUI [5,1]
C0009450
UMLS CUI [5,2]
C0205082
UMLS CUI [6]
C0030920
UMLS CUI [7]
C0005779
UMLS CUI [8]
C0009782
UMLS CUI [9]
C0549484
inadequate liver function (bilirubin > 1.0 times upper normal limit [unl] and alt and/or ast> 1.5 unl associated with alkaline phosphatase > 2.5 unl; inadequate renal function (creatinine > 1.0 times unl and in case of limit value, creatinine clearance < 60 ml/min)
Beskrivning

Liver function Inadequate | Elevated total bilirubin | Alanine aminotransferase increased | Aspartate aminotransferase increased | Alkaline phosphatase raised | Renal function Inadequate | Serum creatinine raised | Creatinine clearance measurement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C0205412
UMLS CUI [2]
C0741494
UMLS CUI [3]
C0151905
UMLS CUI [4]
C0151904
UMLS CUI [5]
C0151849
UMLS CUI [6,1]
C0232804
UMLS CUI [6,2]
C0205412
UMLS CUI [7]
C0700225
UMLS CUI [8]
C0373595
contraindication for using dexamethasone
Beskrivning

Medical contraindication Dexamethasone

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0011777
history of congestive heart failure, uncontrolled or symptomatic angina pectoris, arrhythmia or myocardial infarction; poorly controlled hypertension (systolic bp > 180 mmhg or diastolic bp > 100 mmhg)
Beskrivning

Congestive heart failure | Angina Pectoris Uncontrolled | Angina Pectoris Symptomatic | Cardiac Arrhythmia | Myocardial Infarction | Poor hypertension control | Systolic Pressure | Diastolic blood pressure

Datatyp

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
UMLS CUI [6]
C0421190
UMLS CUI [7]
C0871470
UMLS CUI [8]
C0428883
has peripheral neuropathy ≥ grade 1
Beskrivning

Peripheral Neuropathy CTCAE Grades

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
patient is pregnant or breast feeding
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
known severe hypersensitivity to any drugs in this study
Beskrivning

Severe allergy Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2945656
UMLS CUI [1,2]
C0013230
treatment with any investigational drugs within 30 days before the beginning of study treatment
Beskrivning

Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
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Similar models

Eligibility Breast Cancer NCT00912444

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
women aged ≥ 18 years and < 70 years
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Karnofsky Performance Status
Item
karnofsky performance status (kps) ≥ 70
boolean
C0206065 (UMLS CUI [1])
Measurable Disease Quantity | Invasive carcinoma of breast | Exception Inflammatory Breast Carcinoma | Breast Carcinoma TNM Breast tumor staging | Locally advanced breast cancer TNM Breast tumor staging
Item
at least one measurable disease according to the recist. histologically confirmed invasive breast cancer (excluding inflammatory breast cancer), t2n1 or locally advanced breast cancer (t3-4n0-3 or t0-4n2-3)
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0853879 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0278601 (UMLS CUI [3,2])
C0678222 (UMLS CUI [4,1])
C0474926 (UMLS CUI [4,2])
C3495949 (UMLS CUI [5,1])
C0474926 (UMLS CUI [5,2])
Biopsy sample Estrogen Receptor Detection | Biopsy sample Progesterone Receptor Detection | Biopsy sample HER2 Detection | Triple Negative Breast Neoplasms | HER2-positive carcinoma of breast | HER2 Positive FISH | HER2 Positive CISH | HER2 Positive Immunohistochemistry
Item
biopsy specimens are available for er, pgr and her2 detection, patients should be with triple negative or her2 positive breast cancer, her2 positivity is defined as fish/cish her2 positive or ihc her2 3+, triple-negative disease defined as negativity for er, pgr and her2
boolean
C0677862 (UMLS CUI [1,1])
C0034804 (UMLS CUI [1,2])
C1511790 (UMLS CUI [1,3])
C0677862 (UMLS CUI [2,1])
C0034833 (UMLS CUI [2,2])
C1511790 (UMLS CUI [2,3])
C0677862 (UMLS CUI [3,1])
C0242957 (UMLS CUI [3,2])
C1511790 (UMLS CUI [3,3])
C3539878 (UMLS CUI [4])
C1960398 (UMLS CUI [5])
C2348909 (UMLS CUI [6,1])
C0162789 (UMLS CUI [6,2])
C2348909 (UMLS CUI [7,1])
C1516514 (UMLS CUI [7,2])
C2348909 (UMLS CUI [8,1])
C0021044 (UMLS CUI [8,2])
Bone Marrow function | Neutrophil count | Hemoglobin measurement | Platelet Count measurement
Item
adequate bone marrow function: neutrophil ≥ 1.5*109/l; hb ≥ 100g/l; plt ≥ 100*109/l
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0200633 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
Life Expectancy
Item
an estimated life expectancy of at least 12 months
boolean
C0023671 (UMLS CUI [1])
Biopsy | Neoadjuvant Chemotherapy | Patients Available Treatment | Patients Available Follow-up
Item
willing to take biopsy before neoadjuvant chemotherapy and patients must be accessible for treatment and follow-up
boolean
C0005558 (UMLS CUI [1])
C0600558 (UMLS CUI [2,1])
C3665472 (UMLS CUI [2,2])
C0030705 (UMLS CUI [3,1])
C0470187 (UMLS CUI [3,2])
C0087111 (UMLS CUI [3,3])
C0030705 (UMLS CUI [4,1])
C0470187 (UMLS CUI [4,2])
C3274571 (UMLS CUI [4,3])
Childbearing Potential Urine pregnancy test negative | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Contraceptive methods
Item
women with potential child-bearing must have a negative pregnancy test (urine or serum) within 7 days of drug administration and agree to use an acceptable method of birth control to avoid pregnancy for the duration of the study
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])
Informed Consent
Item
written informed consent according to the gcp
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Systemic therapy Breast Carcinoma | Therapy Local-Regional Breast Carcinoma | Chemotherapy Breast Carcinoma
Item
prior systemic or loco-regional treatment of breast cancer, including chemotherapy
boolean
C1515119 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1947913 (UMLS CUI [2,2])
C0678222 (UMLS CUI [2,3])
C0392920 (UMLS CUI [3,1])
C0678222 (UMLS CUI [3,2])
Secondary malignant neoplasm of female breast
Item
metastatic breast cancer
boolean
C0346993 (UMLS CUI [1])
Malignant Neoplasms | Exception Carcinoma in situ of uterine cervix | Exception Basal cell carcinoma
Item
with a history of malignant tumor except uterine cervix cancer in situ or skin basal cell carcinoma
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
Medical condition intolerant Neoadjuvant Therapy | Medical condition intolerant Therapeutic procedure Similar | Lung disease Uncontrolled | Diabetes Mellitus | Communicable Disease Severe | Peptic Ulcer | Blood Coagulation Disorder | Connective Tissue Disease | Myelosuppression adult
Item
patients with medical conditions that indicate intolerant to neoadjuvant therapy and related treatment, including uncontrolled pulmonary disease, diabetes mellitis, severe infection, active peptic ulcer, coagulation disorder, connective tissue disease or myelo-suppressive disease
boolean
C3843040 (UMLS CUI [1,1])
C0231200 (UMLS CUI [1,2])
C0600558 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0231200 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C2348205 (UMLS CUI [2,4])
C0024115 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0011849 (UMLS CUI [4])
C0009450 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C0030920 (UMLS CUI [6])
C0005779 (UMLS CUI [7])
C0009782 (UMLS CUI [8])
C0549484 (UMLS CUI [9])
Liver function Inadequate | Elevated total bilirubin | Alanine aminotransferase increased | Aspartate aminotransferase increased | Alkaline phosphatase raised | Renal function Inadequate | Serum creatinine raised | Creatinine clearance measurement
Item
inadequate liver function (bilirubin > 1.0 times upper normal limit [unl] and alt and/or ast> 1.5 unl associated with alkaline phosphatase > 2.5 unl; inadequate renal function (creatinine > 1.0 times unl and in case of limit value, creatinine clearance < 60 ml/min)
boolean
C0232741 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
C0741494 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
C0151904 (UMLS CUI [4])
C0151849 (UMLS CUI [5])
C0232804 (UMLS CUI [6,1])
C0205412 (UMLS CUI [6,2])
C0700225 (UMLS CUI [7])
C0373595 (UMLS CUI [8])
Medical contraindication Dexamethasone
Item
contraindication for using dexamethasone
boolean
C1301624 (UMLS CUI [1,1])
C0011777 (UMLS CUI [1,2])
Congestive heart failure | Angina Pectoris Uncontrolled | Angina Pectoris Symptomatic | Cardiac Arrhythmia | Myocardial Infarction | Poor hypertension control | Systolic Pressure | Diastolic blood pressure
Item
history of congestive heart failure, uncontrolled or symptomatic angina pectoris, arrhythmia or myocardial infarction; poorly controlled hypertension (systolic bp > 180 mmhg or diastolic bp > 100 mmhg)
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])
C0421190 (UMLS CUI [6])
C0871470 (UMLS CUI [7])
C0428883 (UMLS CUI [8])
Peripheral Neuropathy CTCAE Grades
Item
has peripheral neuropathy ≥ grade 1
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
patient is pregnant or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Severe allergy Investigational New Drugs
Item
known severe hypersensitivity to any drugs in this study
boolean
C2945656 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Investigational New Drugs
Item
treatment with any investigational drugs within 30 days before the beginning of study treatment
boolean
C0013230 (UMLS CUI [1])
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