Breast Cancer
Item
histologically or cytologically confirmed adenocarcinoma of the male or female breast (male or female) with gross, uncontrolled, unresectable breast and/or chest wall disease including:
boolean
C0858252 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0184774 (UMLS CUI [3])
C1332928 (UMLS CUI [4])
Staging
Item
1. patients with locally advanced unresectable stage iiia or iiib;
boolean
C2216698 (UMLS CUI [1])
C2216699 (UMLS CUI [2])
Locally recurrent disease
Item
2. patients with locally recurrent (including locoregional lymph nodes) disease for which curative surgery is not thought possible
boolean
C0861355 (UMLS CUI [1,1])
C1511562 (UMLS CUI [1,2])
Staging
Item
3. patients with metastatic disease and uncontrolled locoregional disease are eligible.
boolean
C0278488 (UMLS CUI [1])
C1707001 (UMLS CUI [2])
Chemotherapy
Item
prior chemotherapy allowed, except for nitrosoureas and mitomycin chemotherapy or high dose chemotherapy with marrow or stem cell rescue.
boolean
C0392920 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C3540781 (UMLS CUI [1,3])
C0392920 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0002475 (UMLS CUI [2,3])
C0392920 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C1328050 (UMLS CUI [3,3])
palliative radiation
Item
prior palliative radiation to sites of metastases allowed (i.e. bone, brain, lung)
boolean
C3641903 (UMLS CUI [1])
Prior/ concurrent Therapy
Item
4 weeks since any prior treatments (excluding hormonal therapy). concurrent hormonal therapy is not allowed.
boolean
C0808070 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0877050 (UMLS CUI [2])
age
Item
aged 18 years or older
boolean
C0001779 (UMLS CUI [1])
calgb performance status
Item
calgb performance status of 0 - 2
boolean
C1518965 (UMLS CUI [1])
Life expectancy
Item
life expectance of at least 12 weeks
boolean
C0023671 (UMLS CUI [1])
laboratory data
Item
initial laboratory data:
boolean
C0022885 (UMLS CUI [1])
anc count
Item
anc count > 1500/mm3
boolean
C0948762 (UMLS CUI [1])
platelet count
Item
platelet count > 100,000/mm3
boolean
C0032181 (UMLS CUI [1])
creatine
Item
creatine ≤ 2.0 mg/dl
boolean
C0201973 (UMLS CUI [1])
bilirubin
Item
bilirubin ≤ 1.5 mg/dl
boolean
C1278039 (UMLS CUI [1])
Liver enzymes
Item
alt (sgpt) ≤ 3 times the upper limit of normal
boolean
C0201836 (UMLS CUI [1])
informed consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Prior radiation
Item
prior breast or chest wall radiation is not allowed unless the proposed site radiation port does not overlap with prior ports
boolean
C0458344 (UMLS CUI [1])
Gynaecological status
Item
subjects must not be pregnant (females able to have children must have negative pregnancy test and agree to use adequate contraception)
boolean
C0032961 (UMLS CUI [1])
C0032976 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
Allergy
Item
patients with a documented hypersensitivity to e.coli derived proteins are excluded.
boolean
C0020517 (UMLS CUI [1,1])
C0014834 (UMLS CUI [1,2])
C1441547 (UMLS CUI [1,3])
C0033684 (UMLS CUI [1,4])
Comorbidity
Item
no other serious medical condition such as uncontrolled infection that in the opinion of the investigators places patient at undue risk for study treatment
boolean
C2348568 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])