Gender | Age
Item
women aged ≥ 18 years;
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Invasive Ductal Breast Carcinoma | Breast cancer, lobular
Item
histologically and/or cytologically confirmed invasive ductal or lobular breast cancer;
boolean
C1134719 (UMLS CUI [1])
C3549742 (UMLS CUI [2])
Tumor size
Item
tumor of 3 cm or greater at time of diagnosis
boolean
C0475440 (UMLS CUI [1])
Neoadjuvant Therapy Primary tumor Measurable
Item
measurable primary tumor after neoadjuvant treatment before randomization
boolean
C0600558 (UMLS CUI [1,1])
C0677930 (UMLS CUI [1,2])
C1513040 (UMLS CUI [1,3])
Absence Prior Chemotherapy Breast Carcinoma
Item
no prior chemotherapy for breast cancer;
boolean
C0332197 (UMLS CUI [1,1])
C1514457 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
ECOG performance status | Karnofsky Performance Status
Item
ecog performance status ≤1 or karnofsky performace status ≥ 70%
boolean
C1520224 (UMLS CUI [1])
C0206065 (UMLS CUI [2])
Liver function | Renal function
Item
adequate liver/renal function
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
Able to swallow Tablets
Item
able to swallow whole tablets.
boolean
C2712086 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
Informed Consent
Item
able to give written informed consent
boolean
C0021430 (UMLS CUI [1])
Compliance behavior Prescription Instructions
Item
able to follow prescription instructions reasonably well
boolean
C1321605 (UMLS CUI [1,1])
C0033081 (UMLS CUI [1,2])
C1442085 (UMLS CUI [1,3])
Gender
Item
male patient
boolean
C0079399 (UMLS CUI [1])
Cancer Other | Exception Contralateral Breast Carcinoma | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated
Item
prior history of other malignancy within 5 years of study entry, aside from contralateral breast carcinoma, appropriately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C3274709 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0007117 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0553723 (UMLS CUI [5,2])
C1522326 (UMLS CUI [5,3])
Distant metastasis | Skin Involvement outside Breast
Item
distant metastasis, including skin involvement beyond the breast area
boolean
C1269798 (UMLS CUI [1])
C1123023 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
C0205101 (UMLS CUI [2,3])
C0006141 (UMLS CUI [2,4])
Medical condition Severe High risk Study Subject Participation Status | Medical condition Severe High risk Investigational New Drugs | Medical condition Severe Study Subject Participation Status Inappropriate | Medical condition chronic High risk Study Subject Participation Status | Medical condition chronic High risk Investigational New Drugs | Medical condition chronic Study Subject Participation Status Inappropriate | Mental disorders Severe High risk Study Subject Participation Status | Mental disorders Severe High risk Investigational New Drugs | Mental disorders Severe Study Subject Participation Status Inappropriate | Mental disorders chronic High risk Study Subject Participation Status | Mental disorders chronic High risk Investigational New Drugs | Mental disorders chronic Study Subject Participation Status Inappropriate | Laboratory test result abnormal High risk Study Subject Participation Status | Laboratory test result abnormal High risk Investigational New Drugs | Laboratory test result abnormal Study Subject Participation Status Inappropriate
Item
other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study
boolean
C3843040 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0332167 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0332167 (UMLS CUI [2,3])
C0013230 (UMLS CUI [2,4])
C3843040 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
C1548788 (UMLS CUI [3,4])
C3843040 (UMLS CUI [4,1])
C0205191 (UMLS CUI [4,2])
C0332167 (UMLS CUI [4,3])
C2348568 (UMLS CUI [4,4])
C3843040 (UMLS CUI [5,1])
C0205191 (UMLS CUI [5,2])
C0332167 (UMLS CUI [5,3])
C0013230 (UMLS CUI [5,4])
C3843040 (UMLS CUI [6,1])
C0205191 (UMLS CUI [6,2])
C2348568 (UMLS CUI [6,3])
C1548788 (UMLS CUI [6,4])
C0004936 (UMLS CUI [7,1])
C0205082 (UMLS CUI [7,2])
C0332167 (UMLS CUI [7,3])
C2348568 (UMLS CUI [7,4])
C0004936 (UMLS CUI [8,1])
C0205082 (UMLS CUI [8,2])
C0332167 (UMLS CUI [8,3])
C0013230 (UMLS CUI [8,4])
C0004936 (UMLS CUI [9,1])
C0205082 (UMLS CUI [9,2])
C2348568 (UMLS CUI [9,3])
C1548788 (UMLS CUI [9,4])
C0004936 (UMLS CUI [10,1])
C0205191 (UMLS CUI [10,2])
C0332167 (UMLS CUI [10,3])
C2348568 (UMLS CUI [10,4])
C0004936 (UMLS CUI [11,1])
C0205191 (UMLS CUI [11,2])
C0332167 (UMLS CUI [11,3])
C0013230 (UMLS CUI [11,4])
C0004936 (UMLS CUI [12,1])
C0205191 (UMLS CUI [12,2])
C2348568 (UMLS CUI [12,3])
C1548788 (UMLS CUI [12,4])
C0438215 (UMLS CUI [13,1])
C0332167 (UMLS CUI [13,2])
C2348568 (UMLS CUI [13,3])
C0438215 (UMLS CUI [14,1])
C0332167 (UMLS CUI [14,2])
C0013230 (UMLS CUI [14,3])
C0438215 (UMLS CUI [15,1])
C2348568 (UMLS CUI [15,2])
C1548788 (UMLS CUI [15,3])