Gender | Age
Item
1. patients must be female between the ages of 18 to 70 years old.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Secondary malignant neoplasm of female breast Amenable docetaxel | Breast cancer recurrent Amenable docetaxel
Item
2. patients must have histologically or clinically confirmed metastatic and/or recurrent breast cancer amenable to treatment with docetaxel.
boolean
C0346993 (UMLS CUI [1,1])
C3900053 (UMLS CUI [1,2])
C0246415 (UMLS CUI [1,3])
C0278493 (UMLS CUI [2,1])
C3900053 (UMLS CUI [2,2])
C0246415 (UMLS CUI [2,3])
Measurable Disease Linear Quantity | Lesion size Minimal Diameter Largest
Item
3. patients must have presence of at least one uni-dimensional measurable lesion with minimal lesion size > 20 mm at the largest diameter.
boolean
C1513041 (UMLS CUI [1,1])
C0205132 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0449453 (UMLS CUI [2,1])
C0547040 (UMLS CUI [2,2])
C1301886 (UMLS CUI [2,3])
C0443228 (UMLS CUI [2,4])
Chemotherapy Regimen Quantity | Chemotherapy docetaxel
Item
4. patients may have had one previous chemotherapy regimen and must not have received prior chemotherapy with docetaxel.
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C0246415 (UMLS CUI [2,2])
Hormone Therapy Discontinued
Item
5. patients must have been off all hormonal therapy for at least 2 weeks prior to initiation of therapy.
boolean
C0279025 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
Chemotherapy Discontinued | Therapeutic radiology procedure Discontinued
Item
6. patients must have been off all chemotherapy or radiotherapy regimens for at least 4 weeks prior to initiation of chemotherapy.
boolean
C0392920 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
Life Expectancy
Item
7. patients must have a life expectancy of at least 6 months.
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
8. patients must have a ecog status of 0, 1 or 2.
boolean
C1520224 (UMLS CUI [1])
Protocol Compliance
Item
9. patients must be willing to complete all procedures and visits as outlined in the protocol.
boolean
C0525058 (UMLS CUI [1])
Informed Consent
Item
10. patients must sign an informed consent form.
boolean
C0021430 (UMLS CUI [1])
Hematologic Test Negative HIV Infection | Hematologic Test Negative Hepatitis B | Hematologic Test Negative Hepatitis C
Item
11. patients must have negative blood test for hiv and hepatitis b and c.
boolean
C0018941 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
C0019693 (UMLS CUI [1,3])
C0018941 (UMLS CUI [2,1])
C1513916 (UMLS CUI [2,2])
C0019163 (UMLS CUI [2,3])
C0018941 (UMLS CUI [3,1])
C1513916 (UMLS CUI [3,2])
C0019196 (UMLS CUI [3,3])
Childbearing Potential Contraceptive method
Item
12. female patients of child bearing potential should use an effective method of contraception.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Metastatic malignant neoplasm to brain | Metastatic Malignant Neoplasm to the Leptomeninges
Item
1. patients with brain or meningeal metastases.
boolean
C0220650 (UMLS CUI [1])
C1704231 (UMLS CUI [2])
Measurable Disease only bone
Item
2. patients whose only measurable lesion is in the bone.
boolean
C1513041 (UMLS CUI [1,1])
C0205171 (UMLS CUI [1,2])
C0262950 (UMLS CUI [1,3])
Cardiovascular Diseases Clinical Significance | Lung diseases | Kidney Diseases | Endocrine System Diseases | Liver diseases | Respiration Disorders | nervous system disorder | Mental disorders | Immune System Diseases | Gastrointestinal Diseases | Hematological Disease | Metabolic Diseases | Condition Study Subject Participation Status Inappropriate | Laboratory test result abnormal Study Subject Participation Status Inappropriate
Item
3. patients with clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, respiratory, neurologic, psychiatric, immunologic, gastrointestinal, hematologic, metabolic or any other condition or laboratory abnormality that in the opinion of the investigator makes the patient unsuitable for participation in the study.
boolean
C0007222 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0024115 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0014130 (UMLS CUI [4])
C0023895 (UMLS CUI [5])
C0035204 (UMLS CUI [6])
C0027765 (UMLS CUI [7])
C0004936 (UMLS CUI [8])
C0021053 (UMLS CUI [9])
C0017178 (UMLS CUI [10])
C0018939 (UMLS CUI [11])
C0025517 (UMLS CUI [12])
C0348080 (UMLS CUI [13,1])
C2348568 (UMLS CUI [13,2])
C1548788 (UMLS CUI [13,3])
C0438215 (UMLS CUI [14,1])
C2348568 (UMLS CUI [14,2])
C1548788 (UMLS CUI [14,3])
Epilepsy
Item
4. patients with history of seizure disorder.
boolean
C0014544 (UMLS CUI [1])
Investigational New Drugs
Item
5. patients who have received treatment with any other investigational drug within the preceding one month.
boolean
C0013230 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
6. patients who are pregnant or breast feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])