Carcinoma breast stage IV
Item
must have metastatic breast cancer
boolean
C0278488 (UMLS CUI [1])
Invasive Ductal Breast Carcinoma | Carcinoma, Lobular
Item
must have cytologically or pathologically confirmed invasive ductal or lobular carcinoma
boolean
C1134719 (UMLS CUI [1])
C0206692 (UMLS CUI [2])
Measurable Disease | Evaluable Disease
Item
must have measurable or evaluable disease
boolean
C1513041 (UMLS CUI [1])
C1516986 (UMLS CUI [2])
ECOG performance status
Item
ecog of 0-1
boolean
C1520224 (UMLS CUI [1])
Prior Therapy Quantity Carcinoma breast stage IV
Item
patients may have received 0, 1. or 2 prior treatments for metastatic breast cancer
boolean
C1514463 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0278488 (UMLS CUI [1,3])
organ function
Item
must have adequate organ function
boolean
C0678852 (UMLS CUI [1])
Age
Item
must be at least 19 years of age
boolean
C0001779 (UMLS CUI [1])
Peripheral Neuropathy | CTCAE Grades
Item
peripheral neuropathy less than or equal to grade 1
boolean
C0031117 (UMLS CUI [1])
C1516728 (UMLS CUI [2])
Informed Consent
Item
must have voluntarily signed informed consent
boolean
C0021430 (UMLS CUI [1])
Metastatic malignant neoplasm to brain | Measurable Disease | Lesion of brain Controlled
Item
patients with brain metastases are eligible provided that other measurable disease exists and brain lesions are controlled
boolean
C0220650 (UMLS CUI [1])
C1513041 (UMLS CUI [2])
C0221505 (UMLS CUI [3,1])
C2911690 (UMLS CUI [3,2])
Malignant Neoplasms | Skin carcinoma
Item
patients with other malignancies, except non melanoma of the skin, who have had any evidence of cancer within the last 5 years
boolean
C0006826 (UMLS CUI [1])
C0699893 (UMLS CUI [2])
Mental disorder Excludes Clinical Trial Completion | Comorbidity Severe Excludes Clinical Trial Completion
Item
patients with psychiatric illness or other concurrent severe co-morbid medical condition that would preclude study completion
boolean
C0004936 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0205197 (UMLS CUI [1,4])
C0009488 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
C0008976 (UMLS CUI [2,4])
C0205197 (UMLS CUI [2,5])
Blood Coagulation Disorder Uncontrolled
Item
known uncontrolled existing coagulopathy
boolean
C0005779 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
severe allergy docetaxel | severe allergy Polysorbate 80 Formulation | severe allergy Fluorouracil Formulation
Item
patients with a history of severe hypersensitivity reaction to docetaxel, medications formulated with polysorbate 80 or 5-fluorouracil
boolean
C2945656 (UMLS CUI [1,1])
C0246415 (UMLS CUI [1,2])
C2945656 (UMLS CUI [2,1])
C0032601 (UMLS CUI [2,2])
C1705957 (UMLS CUI [2,3])
C2945656 (UMLS CUI [3,1])
C0016360 (UMLS CUI [3,2])
C1705957 (UMLS CUI [3,3])
Investigational New Drugs
Item
use of other investigational agents in the last 28 days
boolean
C0013230 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
HIV Seropositivity
Item
patients who are known hiv positive
boolean
C0019699 (UMLS CUI [1])
Life Expectancy
Item
patients with life expectancy of less than 3 months
boolean
C0023671 (UMLS CUI [1])
Sex Behavior Contraceptive methods Unwilling
Item
sexually active patients unwilling to practice reliable contraception during the study
boolean
C0036864 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])