Eligibility Breast Cancer NCT00450762

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StudyEvent: Eligibility
1. Eligibility Breast Cancer NCT00450762

Name

Type

Description | Question | Decode (Coded Value)

Datatype

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

metastatic breast cancer

Item

histologically confirmed metastatic breast cancer

boolean

C0278488 (UMLS CUI [1])

informed consent

Item

all patients were required to give written informed consent.

boolean

C0021430 (UMLS CUI [1])

Previous treatment

Item

prior treatment with chemotherapy, hormonal therapy, immunotherapy or local radiotherapy was allowed (except gemcitabine or platinum agents).

boolean

C2114510 (UMLS CUI [1])

Measurable lesion outside a previous radiation port

Item

patients were required to have at least one bidimensionally measurable lesion outside a previous radiation port.

boolean

C1513041 (UMLS CUI [1,1])
C1282506 (UMLS CUI [1,2])

Age

Item

age ≥ 18 years

boolean

C0001779 (UMLS CUI [1])

karnofsky performance status

Item

karnofsky performance status ≥ 70 %

boolean

C0206065 (UMLS CUI [1])

Life expectancy

Item

minimal life expectancy of 12 weeks

boolean

C0023671 (UMLS CUI [1])

Organ function

Item

adequate haematological, renal, cardiac and hepatic function:

boolean

C0678852 (UMLS CUI [1])

leukocyte count

Item

1. leukocyte count ≥ 3.0 x 109/l

boolean

C0023508 (UMLS CUI [1])

absolute neutrophil count

Item

2. absolute neutrophil count ≥ 2.0 x 109/l

boolean

C0948762 (UMLS CUI [1])

platelet count

Item

3. platelet count ≥ 100 x 109/l

boolean

C0005821 (UMLS CUI [1])

haemoglobin

Item

4. haemoglobin ≥ 8 g/dl

boolean

C0518015 (UMLS CUI [1])

total serum bilirubin

Item

5. total serum bilirubin ≤ 1.25 x upper limit of normal (uln) in presence of liver metastasis ≤ 3 x uln

boolean

C1278039 (UMLS CUI [1])
C0494165 (UMLS CUI [2])

transaminases

Item

6. transaminase (alt,ast) level ≤ 3 x uln in presence of liver metastasis ≤ 5 x uln

boolean

C0002594 (UMLS CUI [1])
C0494165 (UMLS CUI [2])

alkaline phosphatase level

Item

7. alkaline phosphatase level ≤ 2.5 x uln

boolean

C1272113 (UMLS CUI [1])

creatinine clearance

Item

8. creatinine clearance was required to exceed 60 ml/min.

boolean

C0373595 (UMLS CUI [1])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

Gemcitabine or platinum agents

Item

prior treatment with gemcitabine or platinum agents

boolean

C0045093 (UMLS CUI [1])
C2266918 (UMLS CUI [2])

creatinine clearance

Item

inadequate creatinine clearance (< 60 ml/min)

boolean

C0373595 (UMLS CUI [1])

bone metastases

Item

only bone metastases

boolean

C0153690 (UMLS CUI [1])

brain metastases

Item

symptomatic brain metastases

boolean

C0220650 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])

women who are pregnant, lactating or refuse effective contraception

Item

women who are pregnant, lactating or refuse effective contraception

boolean

C0425965 (UMLS CUI [1])
C0549206 (UMLS CUI [2])
C2828358 (UMLS CUI [3])

secondary malignancy

Item

secondary malignancy

boolean

C3266877 (UMLS CUI [1])

another primary malignant disease

Item

history of another primary malignant disease other than in situ carcinoma of the uterine cervix or adequately treated basal cell skin cancer

boolean

C0751623 (UMLS CUI [1])

active infection

Item

active infection

boolean

C0009450 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])

comorbidity

Item

any other concomitant severe clinical condition making implementation of the protocol including pre-hydration difficult.

boolean

C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])

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Eligibility Breast Cancer NCT00450762