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])
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])