Breast cancer recurrent Chemotherapy refractory | Secondary malignant neoplasm of female breast Chemotherapy refractory | Breast cancer recurrent Measurable | Secondary malignant neoplasm of female breast Measurable
Item
1. histologically or cytologically confirmed recurrent or metastatic breast cancer that is refractory to standard chemotherapy and that is measurable.
boolean
C0278493 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0205269 (UMLS CUI [1,3])
C0346993 (UMLS CUI [2,1])
C0392920 (UMLS CUI [2,2])
C0205269 (UMLS CUI [2,3])
C0278493 (UMLS CUI [3,1])
C1513040 (UMLS CUI [3,2])
C0346993 (UMLS CUI [4,1])
C1513040 (UMLS CUI [4,2])
Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement | Secondary malignant neoplasm of bone Extensive | Alkaline phosphatase raised Due to Liver disease Extensive | Albumin measurement | Ascites Absent | Prothrombin time normal | Activated partial thromboplastin time normal
Item
2. adequate hepatic function: total bilirubin < 2.0 mg/dl (upper limit included); ast/alt < 2x institutional norm; alkaline phosphatase < 2.5x upper limit of institutional norm unless the patient has extensive bone metastases. patients with elevated alkaline phosphatase due to extensive liver disease will be excluded from study; albumin > 3.0 mg/dl. there must be no substantial ascites. pt and ptt must be within normal limits.
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0201850 (UMLS CUI [5])
C0153690 (UMLS CUI [6,1])
C0205231 (UMLS CUI [6,2])
C0151849 (UMLS CUI [7,1])
C0678226 (UMLS CUI [7,2])
C0023895 (UMLS CUI [7,3])
C0205231 (UMLS CUI [7,4])
C0201838 (UMLS CUI [8])
C0003962 (UMLS CUI [9,1])
C0332197 (UMLS CUI [9,2])
C0580551 (UMLS CUI [10])
C0853632 (UMLS CUI [11])
ECOG performance status | Life Expectancy
Item
3. performance status must be < 1 (ecog 0-1) with a life expectancy of at least 3 months.
boolean
C1520224 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
Hemoglobin measurement
Item
4. hemoglobin > 9 gms%
boolean
C0518015 (UMLS CUI [1])
Absolute neutrophil count | Platelet Count measurement
Item
5. absolute granulocyte count > 1000/ul, and platelet count > 100,000/ul.
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
Creatinine measurement, serum
Item
6. serum creatinine of less than 1.5 mg%.
boolean
C0201976 (UMLS CUI [1])
Cancer treatment Plan Absent
Item
7. there must be no plans for the patient to receive further cancer therapy from the date of enrollment until the completion of the 6-week follow-up visit.
boolean
C0920425 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Accessibility Line Peripheral | Accessibility Line Intravenous central
Item
8. accessibility of peripheral or central iv line
boolean
C0814423 (UMLS CUI [1,1])
C0700221 (UMLS CUI [1,2])
C0205100 (UMLS CUI [1,3])
C0814423 (UMLS CUI [2,1])
C0700221 (UMLS CUI [2,2])
C0595846 (UMLS CUI [2,3])
Age
Item
9. age > 18 years
boolean
C0001779 (UMLS CUI [1])
Chemotherapy Discontinued | Toxicity CTCAE Grades Patient recovered
Item
10. patients will be off chemotherapy for a minimum of 4 weeks prior to initiation of therapy and should have recovered to grade 1 or less toxicity.
boolean
C0392920 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0600688 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
C1115804 (UMLS CUI [2,3])
Informed Consent
Item
11. the ability to understand and the willingness to sign a written informed consent document.
boolean
C0021430 (UMLS CUI [1])
Malignant Neoplasms | Skin carcinoma | Breast Carcinoma TNM Breast tumor staging | Carcinoma in situ of uterine cervix | Disease Free of
Item
1. prior malignancy, except for non-melanoma skin cancer, stage 1 breast cancer, cis of cervix from which the patient has been disease-free for 5 years.
boolean
C0006826 (UMLS CUI [1])
C0699893 (UMLS CUI [2])
C0678222 (UMLS CUI [3,1])
C0474926 (UMLS CUI [3,2])
C0851140 (UMLS CUI [4])
C0012634 (UMLS CUI [5,1])
C0332296 (UMLS CUI [5,2])
Pregnancy | Breast Feeding
Item
2. woman who are pregnant or nursing
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Gender Barrier Contraception | Female Condoms | Vaginal Spermicides
Item
3. fertile patients unless they agree to use barrier contraception (condoms and spermicide jelly) during the vector infusion period and for six weeks after infusion. male patients must agree to use barrier contraception.
boolean
C0079399 (UMLS CUI [1,1])
C0004764 (UMLS CUI [1,2])
C0221829 (UMLS CUI [2])
C0087145 (UMLS CUI [3])
Blood transfusion dependent | Blood Transfusion Quantity per month
Item
4. patients who are transfusion dependent (more than one transfusion per month)
boolean
C1698624 (UMLS CUI [1])
C0005841 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0439507 (UMLS CUI [2,3])
Medical condition compromises Protocol Compliance | Mental disorders compromise Protocol Compliance | Social Conditions compromise Protocol Compliance
Item
5. patients with medical, psychiatric, or social conditions that would compromise successful adherence to this protocol.
boolean
C3843040 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0004936 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C0037403 (UMLS CUI [3,1])
C2945640 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
Inclusion criteria Mismatch
Item
6. patient who do not meet the inclusion criteria.
boolean
C1512693 (UMLS CUI [1,1])
C1881865 (UMLS CUI [1,2])