Gender | Locally advanced breast cancer | No metastases | Prior Therapy
Item
women with histological proven labc, without metastasis, and no prior therapy. labc is defined as follows：
boolean
C0079399 (UMLS CUI [1])
C3495949 (UMLS CUI [2])
C0445092 (UMLS CUI [3])
C1514463 (UMLS CUI [4])
Tumor size Diameter
Item
1. tumor more than 5 cm in diameter
boolean
C0475440 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
Malignant Neoplasms Involvement with Chest wall | Malignant Neoplasms Involvement with rib | Malignant Neoplasms Involvement with intercostal muscle | Malignant Neoplasms Involvement with serratus anterior muscle | Malignant Neoplasms Involvement with Skin | Edematous skin Ipsilateral | Ulceration | Satellite Nodule
Item
2. tumor involvement of chest wall (ribs or intercostals or serratus anterior muscles) or skin (ipsilateral cutaneous edema, ulceration, or satellite nodules)
boolean
C0006826 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C0205076 (UMLS CUI [1,3])
C0006826 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
C0035561 (UMLS CUI [2,3])
C0006826 (UMLS CUI [3,1])
C1314939 (UMLS CUI [3,2])
C0021724 (UMLS CUI [3,3])
C0006826 (UMLS CUI [4,1])
C1314939 (UMLS CUI [4,2])
C0224349 (UMLS CUI [4,3])
C0006826 (UMLS CUI [5,1])
C1314939 (UMLS CUI [5,2])
C1123023 (UMLS CUI [5,3])
C0521464 (UMLS CUI [6,1])
C0441989 (UMLS CUI [6,2])
C3887532 (UMLS CUI [7])
C1710016 (UMLS CUI [8])
Inflammatory carcinoma
Item
3. clinical evident inflammatory carcinoma
boolean
C0334385 (UMLS CUI [1])
Axillary lymphadenopathy Fixed Ipsilateral
Item
4. ipsilateral fixed axillary adenopathy
boolean
C0578735 (UMLS CUI [1,1])
C3714578 (UMLS CUI [1,2])
C0441989 (UMLS CUI [1,3])
Measurable Disease Physical Examination | Ultrasonography, Mammary | Diagnostic Imaging
Item
measurable disease by physical examination, breast sonography and other image study
boolean
C1513041 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C0080264 (UMLS CUI [2])
C0011923 (UMLS CUI [3])
Karnofsky Performance Status
Item
kps≧ 70%
boolean
C0206065 (UMLS CUI [1])
Bone Marrow Mature Neutrophils Adequate | White Blood Cell Count procedure | Absolute neutrophil count | Blood Platelets
Item
adequate bone marrow reserve, defined as white blood cell (wbc)≧ 3,500/ mm3, absolute neutrophil count (anc)≧ 1,500/mm3, platelets ≧ 100,000/mm3
boolean
C0005953 (UMLS CUI [1,1])
C1708947 (UMLS CUI [1,2])
C0205411 (UMLS CUI [1,3])
C0023508 (UMLS CUI [2])
C0948762 (UMLS CUI [3])
C0005821 (UMLS CUI [4])
Liver function | Renal function | Bilirubin, total measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Creatinine measurement, serum
Item
adequate liver and kidney function: total bilirubin ≦ 2.0 mg/dl, serum alanine transaminases (alt) and aspartate transaminase (ast) ≦ 3 times upper normal limit, serum creatinine ≦ 1.5 mg/dl
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0201913 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0201899 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
Age
Item
patients must be ≦ 65 years old
boolean
C0001779 (UMLS CUI [1])
Informed consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Prior Therapy Locally advanced breast cancer | Hormone Therapy | Chemotherapy | Therapeutic radiology procedure | Biological Therapy
Item
patients who have received prior treatment (including hormonal therapy, chemotherapy, radiotherapy or biological therapy) for labc. concomitant use of above therapy will no be allowed.
boolean
C1514463 (UMLS CUI [1,1])
C3495949 (UMLS CUI [1,2])
C0279025 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
C1522449 (UMLS CUI [4])
C0005527 (UMLS CUI [5])
Pregnancy | Breast Feeding
Item
pregnant or lactating woman
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Metastatic Neoplasm | Secondary malignant neoplasm of lymph node regional | Secondary malignant neoplasm of lymph node supraclavicular
Item
metastases disease other than regional lymph node metastases (supraclavicular lymph node metastases is not eligible)
boolean
C2939420 (UMLS CUI [1])
C0686619 (UMLS CUI [2,1])
C0205147 (UMLS CUI [2,2])
C0686619 (UMLS CUI [3,1])
C0229730 (UMLS CUI [3,2])
Heart Diseases Serious | Angina Pectoris | Myocardial Infarction | Cardiomyopathies | Cardiovascular Diseases Severe | Cardiac Arrhythmia
Item
prior serious cardiac conditions such as angina, myocardial infarction, cardiomyopathy, severe cardiovascular disease or cardiac arrhythmias
boolean
C0018799 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0002962 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0878544 (UMLS CUI [4])
C0007222 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C0003811 (UMLS CUI [6])
Systemic disease Serious Inappropriate Study Protocol
Item
serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator)
boolean
C0442893 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
C2348563 (UMLS CUI [1,4])
Secondary Malignant Neoplasm | Carcinoma in situ of uterine adnexa | Basal cell carcinoma Treated
Item
secondary malignancy in past five years before entry of the study (except in situ carcinoma of the cervix, or adequately treated basal cell carcinoma of the skin)
boolean
C3266877 (UMLS CUI [1])
C0686259 (UMLS CUI [2])
C0007117 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
Communicable Diseases
Item
active infection (at the discretion of the investigator)
boolean
C0009450 (UMLS CUI [1])
nervous system disorder Significant | Seizures | Mental disorders
Item
significant neurological (such as seizures) or psychiatric disorder
boolean
C0027765 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0036572 (UMLS CUI [2])
C0004936 (UMLS CUI [3])