ID

38238

Beschrijving

Dose-dense (Biweekly) Carboplatin Plus Paclitaxel With or Without Trastuzumab as Neoadjuvant Treatment for Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02059876

Link

https://clinicaltrials.gov/show/NCT02059876

Trefwoorden

Versies (1)
  1. 01-10-19 01-10-19 -
Houder van rechten

See clinicaltrials.gov

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1 oktober 2019

DOI

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Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02059876

Engels

Eligibility Breast Cancer NCT02059876

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed invasive breast carcinoma
Beschrijving

Invasive carcinoma of breast

Datatype

boolean

Alias
UMLS CUI [1]
C0853879
clinical stage ⅱ-ⅲb
Beschrijving

TNM Breast tumor staging

Datatype

boolean

Alias
UMLS CUI [1]
C0474926
patients must have measurable disease as defined by palpable lesion with both diameters ≥2cm measurable with caliper and/or a positive mammogram or ultrasound with at least one dimension ≥2cm. bilateral mammogram and clip placement is required for study entry. baseline measurements of the indicator lesions must be recorded on the patient registration form. to be valid for baseline, the measurements must have been made within the 14 days if palpable. if not palpable, a mammogram or mri must be done within 14 days. if palpable, a mammogram or mri must be done within 2 months prior to study entry. if clinically indicated, xrays and scans must be done within 28 days of study entry.
Beschrijving

Measurable Disease | Lesion Palpable | Diameter Measurable Caliper | Mammography Positive | Diameter Linear Ultrasonography | Bilateral mammography Required | Clip placement Required | MRI | CT | Scans

Datatype

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C0522499
UMLS CUI [3,1]
C1301886
UMLS CUI [3,2]
C1513040
UMLS CUI [3,3]
C0175720
UMLS CUI [4,1]
C0024671
UMLS CUI [4,2]
C1514241
UMLS CUI [5,1]
C1301886
UMLS CUI [5,2]
C0205132
UMLS CUI [5,3]
C0041618
UMLS CUI [6,1]
C0203027
UMLS CUI [6,2]
C1514873
UMLS CUI [7,1]
C4489472
UMLS CUI [7,2]
C1514873
UMLS CUI [8]
C0024485
UMLS CUI [9]
C0040405
UMLS CUI [10]
C0441633
eastern cooperative oncology group(ecog) performance status 0 to 1 within 14 days of study entry
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
normal (greater than 50%) left ventricular ejection fraction (lvef) by echocardiography
Beschrijving

Left ventricular ejection fraction Echocardiography

Datatype

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0013516
signed informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
adequate organ function within 2 weeks of study entry:
Beschrijving

Organ function

Datatype

boolean

Alias
UMLS CUI [1]
C0678852
1. absolute neutrophil count >1500/mm3, hgb >9.0 g/dl and platelet count >100,000/mm3
Beschrijving

Absolute neutrophil count | Hemoglobin measurement | Platelet Count measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0518015
UMLS CUI [3]
C0032181
2. total bilirubin < upper limit of normal
Beschrijving

Serum total bilirubin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C1278039
3. creatinine < 1.5 mg/dl or calculated cranial cruciate ligament (crcl) >50ml/min using the cockcroft gault equation
Beschrijving

Creatinine measurement, serum | Other Coding | Estimation of creatinine clearance by Cockcroft-Gault formula

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C3846158
UMLS CUI [3]
C2711451
4. serum glutamate oxaloacetate transaminase(sgot)(ast) or serum glutamic oxaloacetic transaminase(sgpt)(alt) and alkaline phosphatase must be within the range allowing for eligibility
Beschrijving

Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
UMLS CUI [3]
C0201850
patients must be over 18 years old.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment
Beschrijving

Childbearing Potential Serum pregnancy test negative

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation.
Beschrijving

Childbearing Potential Contraceptive methods | Gender Contraceptive methods | Contraception, Barrier

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0700589
UMLS CUI [3]
C0004764
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
metastatic disease
Beschrijving

Neoplasm Metastasis

Datatype

boolean

Alias
UMLS CUI [1]
C0027627
prior chemotherapy, hormonal therapy, biologic therapy, investigational agent, targeted therapy or radiation therapy for current breast cancer. patients with history of breast cancer greater than 5 years from initial diagnosis are eligible for the study. patients may not have received anthracycline-based chemotherapy in the past. patients with history of ductal carcinoma in situ(dcis) are eligible if there were treated with surgery alone.
Beschrijving

Prior Chemotherapy Breast Carcinoma | Prior Hormone Therapy Breast Carcinoma | Biological treatment Breast Carcinoma | Investigational New Drugs Breast Carcinoma | Targeted Therapy Breast Carcinoma | Prior radiation therapy Breast Carcinoma | Chemotherapy Anthracycline Based

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0678222
UMLS CUI [2,1]
C1514460
UMLS CUI [2,2]
C0678222
UMLS CUI [3,1]
C1531518
UMLS CUI [3,2]
C0678222
UMLS CUI [4,1]
C0013230
UMLS CUI [4,2]
C0678222
UMLS CUI [5,1]
C2985566
UMLS CUI [5,2]
C0678222
UMLS CUI [6,1]
C0279134
UMLS CUI [6,2]
C0678222
UMLS CUI [7,1]
C0392920
UMLS CUI [7,2]
C0282564
UMLS CUI [7,3]
C1705938
history of previous or current malignancy at other sites with the exception of adequately treated carcinoma in-situ of the cervix or basal or squamous cell carcinoma of the skin. patients with a history of other malignancies, who remain disease free for greater than five years are eligible.
Beschrijving

Cancer Other | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Disease Free Duration

Datatype

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0851140
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0553723
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0012634
UMLS CUI [5,3]
C0332296
UMLS CUI [5,4]
C0449238
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Similar models

Eligibility Breast Cancer NCT02059876

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Invasive carcinoma of breast
Item
histologically or cytologically confirmed invasive breast carcinoma
boolean
C0853879 (UMLS CUI [1])
TNM Breast tumor staging
Item
clinical stage ⅱ-ⅲb
boolean
C0474926 (UMLS CUI [1])
Measurable Disease | Lesion Palpable | Diameter Measurable Caliper | Mammography Positive | Diameter Linear Ultrasonography | Bilateral mammography Required | Clip placement Required | MRI | CT | Scans
Item
patients must have measurable disease as defined by palpable lesion with both diameters ≥2cm measurable with caliper and/or a positive mammogram or ultrasound with at least one dimension ≥2cm. bilateral mammogram and clip placement is required for study entry. baseline measurements of the indicator lesions must be recorded on the patient registration form. to be valid for baseline, the measurements must have been made within the 14 days if palpable. if not palpable, a mammogram or mri must be done within 14 days. if palpable, a mammogram or mri must be done within 2 months prior to study entry. if clinically indicated, xrays and scans must be done within 28 days of study entry.
boolean
C1513041 (UMLS CUI [1])
C0221198 (UMLS CUI [2,1])
C0522499 (UMLS CUI [2,2])
C1301886 (UMLS CUI [3,1])
C1513040 (UMLS CUI [3,2])
C0175720 (UMLS CUI [3,3])
C0024671 (UMLS CUI [4,1])
C1514241 (UMLS CUI [4,2])
C1301886 (UMLS CUI [5,1])
C0205132 (UMLS CUI [5,2])
C0041618 (UMLS CUI [5,3])
C0203027 (UMLS CUI [6,1])
C1514873 (UMLS CUI [6,2])
C4489472 (UMLS CUI [7,1])
C1514873 (UMLS CUI [7,2])
C0024485 (UMLS CUI [8])
C0040405 (UMLS CUI [9])
C0441633 (UMLS CUI [10])
ECOG performance status
Item
eastern cooperative oncology group(ecog) performance status 0 to 1 within 14 days of study entry
boolean
C1520224 (UMLS CUI [1])
Left ventricular ejection fraction Echocardiography
Item
normal (greater than 50%) left ventricular ejection fraction (lvef) by echocardiography
boolean
C0428772 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
Informed Consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Organ function
Item
adequate organ function within 2 weeks of study entry:
boolean
C0678852 (UMLS CUI [1])
Absolute neutrophil count | Hemoglobin measurement | Platelet Count measurement
Item
1. absolute neutrophil count >1500/mm3, hgb >9.0 g/dl and platelet count >100,000/mm3
boolean
C0948762 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Serum total bilirubin measurement
Item
2. total bilirubin < upper limit of normal
boolean
C1278039 (UMLS CUI [1])
Creatinine measurement, serum | Other Coding | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
3. creatinine < 1.5 mg/dl or calculated cranial cruciate ligament (crcl) >50ml/min using the cockcroft gault equation
boolean
C0201976 (UMLS CUI [1])
C3846158 (UMLS CUI [2])
C2711451 (UMLS CUI [3])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement
Item
4. serum glutamate oxaloacetate transaminase(sgot)(ast) or serum glutamic oxaloacetic transaminase(sgpt)(alt) and alkaline phosphatase must be within the range allowing for eligibility
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0201850 (UMLS CUI [3])
Age
Item
patients must be over 18 years old.
boolean
C0001779 (UMLS CUI [1])
Childbearing Potential Serum pregnancy test negative
Item
women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
Childbearing Potential Contraceptive methods | Gender Contraceptive methods | Contraception, Barrier
Item
women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0004764 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Neoplasm Metastasis
Item
metastatic disease
boolean
C0027627 (UMLS CUI [1])
Prior Chemotherapy Breast Carcinoma | Prior Hormone Therapy Breast Carcinoma | Biological treatment Breast Carcinoma | Investigational New Drugs Breast Carcinoma | Targeted Therapy Breast Carcinoma | Prior radiation therapy Breast Carcinoma | Chemotherapy Anthracycline Based
Item
prior chemotherapy, hormonal therapy, biologic therapy, investigational agent, targeted therapy or radiation therapy for current breast cancer. patients with history of breast cancer greater than 5 years from initial diagnosis are eligible for the study. patients may not have received anthracycline-based chemotherapy in the past. patients with history of ductal carcinoma in situ(dcis) are eligible if there were treated with surgery alone.
boolean
C1514457 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C1514460 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
C1531518 (UMLS CUI [3,1])
C0678222 (UMLS CUI [3,2])
C0013230 (UMLS CUI [4,1])
C0678222 (UMLS CUI [4,2])
C2985566 (UMLS CUI [5,1])
C0678222 (UMLS CUI [5,2])
C0279134 (UMLS CUI [6,1])
C0678222 (UMLS CUI [6,2])
C0392920 (UMLS CUI [7,1])
C0282564 (UMLS CUI [7,2])
C1705938 (UMLS CUI [7,3])
Cancer Other | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Disease Free Duration
Item
history of previous or current malignancy at other sites with the exception of adequately treated carcinoma in-situ of the cervix or basal or squamous cell carcinoma of the skin. patients with a history of other malignancies, who remain disease free for greater than five years are eligible.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0012634 (UMLS CUI [5,2])
C0332296 (UMLS CUI [5,3])
C0449238 (UMLS CUI [5,4])
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