Gender | Breast Carcinoma
Item
must be female with histologically confirmed breast cancer
boolean
C0079399 (UMLS CUI [1])
C0678222 (UMLS CUI [2])
TNM clinical staging
Item
stage ii-iv disease
boolean
C3258246 (UMLS CUI [1])
Estrogen receptor positive | progesterone receptor positive
Item
er and/or pr positive
boolean
C0279754 (UMLS CUI [1])
C0279759 (UMLS CUI [2])
ECOG performance status
Item
ecog performance status 0-1
boolean
C1520224 (UMLS CUI [1])
Malignant Neoplasm Presence following Core needle biopsy | Physical Examination | Evaluation Radiographic
Item
tumor must be present following core needle biopsy as determined by physical exam or radiographic evaluation.
boolean
C0006826 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
C0231290 (UMLS CUI [1,3])
C1318309 (UMLS CUI [1,4])
C0031809 (UMLS CUI [2])
C0220825 (UMLS CUI [3,1])
C0444708 (UMLS CUI [3,2])
Postmenopausal state
Item
postmenopausal
boolean
C0232970 (UMLS CUI [1])
Prior Therapy Breast Carcinoma | Therapeutic procedure Basal cell carcinoma | Therapeutic procedure Squamous cell carcinoma of skin | Therapeutic procedure Carcinoma in situ of uterine cervix | Therapeutic procedure Malignant Neoplasms | Disease Free of | Diphosphonates Secondary malignant neoplasm of bone | Palliative Radiation Therapy Secondary malignant neoplasm of bone
Item
no prior treatment for current breast cancer. no other active malignancy is allowed.adequately treated basal cell, squamous cell skin cancer, in situ cervical cancer, or any other cancer from which the patient has been disease-free for 5 years is permitted. biphosphonates and palliative radiation for bone metastasis is permitted while on study.
boolean
C1514463 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C0087111 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C0087111 (UMLS CUI [5,1])
C0006826 (UMLS CUI [5,2])
C0012634 (UMLS CUI [6,1])
C0332296 (UMLS CUI [6,2])
C0012544 (UMLS CUI [7,1])
C0153690 (UMLS CUI [7,2])
C3898008 (UMLS CUI [8,1])
C0153690 (UMLS CUI [8,2])
Hormone replacement therapy Discontinued
Item
hormone replacement therapy must be discontinued. it is not permitted during the time on study.
boolean
C0282402 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
Asthma, Aspirin-Induced | Urticaria | Allergic Reaction | Hypersensitivity Sulfonamides | Requirement Therapeutic procedure Emergency room | Requirement Hospitalization
Item
known history of aspirin or nsaid induced asthma, urticaria or allergic reactions; or allergy to sulfonamides severe enough in nature to require emergency room treatment or hospitalization.
boolean
C1319853 (UMLS CUI [1])
C0042109 (UMLS CUI [2])
C1527304 (UMLS CUI [3])
C0020517 (UMLS CUI [4,1])
C0038760 (UMLS CUI [4,2])
C1514873 (UMLS CUI [5,1])
C0087111 (UMLS CUI [5,2])
C0562508 (UMLS CUI [5,3])
C1514873 (UMLS CUI [6,1])
C0019993 (UMLS CUI [6,2])
Myocardial Infarction | Event Thrombotic
Item
history of myocardial infarction or other thrombotic events.
boolean
C0027051 (UMLS CUI [1])
C0441471 (UMLS CUI [2,1])
C0087086 (UMLS CUI [2,2])
Inflammatory Breast Carcinoma | Edema of breast | Ulceration of breast
Item
inflammatory breast cancer (edema or ulceration of the skin of the breast).
boolean
C0278601 (UMLS CUI [1])
C0235649 (UMLS CUI [2])
C0425793 (UMLS CUI [3])
Renal dysfunction Significant | Creatinine measurement, serum
Item
significant renal dysfunction (serum creatinine > 1.5 x upper limit of normal).
boolean
C3279454 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0201976 (UMLS CUI [2])
Liver Dysfunction Significant | Serum bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
significant hepatic dysfunction (serum bilirubin > 1.5 x upper limit of normal or ast, alt > 3 x upper limit of normal)
boolean
C0086565 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0428441 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
Absolute neutrophil count | Blood Platelets | Hemoglobin
Item
anc <1.5, platelets <100,000 k/ul, and hemoglobin < 9 g/dl.
boolean
C0948762 (UMLS CUI [1])
C0005821 (UMLS CUI [2])
C0019046 (UMLS CUI [3])
Cyclooxygenase 2 Inhibitors | rofecoxib | Vioxx | Aspirin | Trisalicyclate | Trilisate | Washout Period | Aspirin Low Dose
Item
use of other cox-2 inhibitors such as rofecoxib (vioxx®, aspirin, trisalicylate (trilisate®), is not permitted during the time on study. no washout period is required. baby aspirin, 81 mg po daily, is permitted.
boolean
C1257954 (UMLS CUI [1])
C0762662 (UMLS CUI [2])
C0876768 (UMLS CUI [3])
C0004057 (UMLS CUI [4])
C0719064 (UMLS CUI [5])
C0878190 (UMLS CUI [6])
C1710661 (UMLS CUI [7])
C2608320 (UMLS CUI [8])
Anti-Inflammatory Agents, Non-Steroidal | Ibuprofen | Advil | Motrin | Aleve | Naprosyn | Anaprox | Etodolac | Lodine | oxaprozin | Daypro | Dolobid | nabumetone | Tolmetin | Tolectin
Item
use of nsaid's such as ibuprofen (advil® or motrin®), naproxyn (aleve® naprosyn®, or anaprox®), etodolac (lodine®), oxaprozin (daypro®), difusanil (dolobid®), nabumetone (relafin®), or tolmetin (tolectin®) is not permitted during the time on study.
boolean
C0003211 (UMLS CUI [1])
C0020740 (UMLS CUI [2])
C0593507 (UMLS CUI [3])
C0699203 (UMLS CUI [4])
C0718343 (UMLS CUI [5])
C0700017 (UMLS CUI [6])
C0699095 (UMLS CUI [7])
C0059865 (UMLS CUI [8])
C0700001 (UMLS CUI [9])
C0069739 (UMLS CUI [10])
C0603695 (UMLS CUI [11])
C0699201 (UMLS CUI [12])
C0068334 (UMLS CUI [13])
C0040377 (UMLS CUI [14])
C0733360 (UMLS CUI [15])