Secondary malignant neoplasm of female breast
Item
patients with a histologically or cytologically proven metastatic breast cancer.
boolean
C0346993 (UMLS CUI [1])
Measurable Disease 2-Dimensional Quantity | Measurable Disease Diameter | Bone lesion Evaluable | Biopsy Absent
Item
patients with at least one bidimensionally measurable lesion (diameter > 1 cm), or an evaluable bone lesion that will not undergo biopsy.
boolean
C1513041 (UMLS CUI [1,1])
C1705052 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1513041 (UMLS CUI [2,1])
C1301886 (UMLS CUI [2,2])
C0238792 (UMLS CUI [3,1])
C1516986 (UMLS CUI [3,2])
C0005558 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Age
Item
age > 18 years.
boolean
C0001779 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of at least 6 months.
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0-3.
boolean
C1520224 (UMLS CUI [1])
Laboratory Results | Absolute neutrophil count | Platelet Count measurement | Aspartate aminotransferase measurement | Serum total bilirubin measurement | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
screening laboratories within the following parameters: anc > 1500 cells/mm3, platelets > 100,000 cells/mm3, ast < 2 x upper limit of normal, bilirubin < 1.5 x upper limit of normal, calculated creatinine clearance > 30 cc/min by the cockroft and gault equation.
boolean
C1254595 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C1278039 (UMLS CUI [5])
C2711451 (UMLS CUI [6])
Hormone Therapy | trastuzumab
Item
concurrent treatment with hormonal therapy or trastuzumab is allowed.
boolean
C0279025 (UMLS CUI [1])
C0728747 (UMLS CUI [2])
Postmenopausal Due to Operative Surgical Procedures | Amenorrhea Duration | Sexual Abstinence | Contraceptive methods | Intrauterine Devices | Contraception, Barrier | Sexual Partner Infertility | Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Lacking
Item
patients must be post-menopausal (either as a result of surgery, or amenorrhea for at least 12 consecutive months), or they must be practicing either abstinence, an adequate method of contraception (intrauterine device or barrier contraception), or their sexual partner must be sterile. women who are pregnant, breast-feeding, or who are fertile and not practicing an adequate means of contraception will be excluded.
boolean
C0232970 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
C0002453 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
C0036899 (UMLS CUI [3])
C0700589 (UMLS CUI [4])
C0021900 (UMLS CUI [5])
C0004764 (UMLS CUI [6])
C0036911 (UMLS CUI [7,1])
C0021359 (UMLS CUI [7,2])
C0032961 (UMLS CUI [8])
C0006147 (UMLS CUI [9])
C3831118 (UMLS CUI [10,1])
C0700589 (UMLS CUI [10,2])
C0332268 (UMLS CUI [10,3])
Central venous catheter
Item
patients must have a central venous catheter.
boolean
C1145640 (UMLS CUI [1])
Informed Consent
Item
patients must be able to give informed consent indicating that they are aware of the investigational nature of this study.
boolean
C0021430 (UMLS CUI [1])
CNS metastases
Item
no known cns metastases.
boolean
C0686377 (UMLS CUI [1])
Cytotoxic Chemotherapy | Aprotinin
Item
no treatment with cytotoxic chemotherapy allowed within 21 days of treatment with aprotinin.
boolean
C0677881 (UMLS CUI [1])
C0003641 (UMLS CUI [2])
Investigational New Drugs | Aprotinin
Item
no treatment with investigational agents allowed within 21 days of treatment with aprotinin.
boolean
C0013230 (UMLS CUI [1])
C0003641 (UMLS CUI [2])
Cardiovascular Disease Severe | Cardiac Arrhythmia | Congestive heart failure Uncompensated | Angina, Unstable | Myocardial Infarction
Item
no severe cardiovascular disease including unstable heart rhythm, uncompensated congestive heart failure, unstable angina or myocardial infarction within 6 months.
boolean
C0007222 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0003811 (UMLS CUI [2])
C0018802 (UMLS CUI [3,1])
C0205433 (UMLS CUI [3,2])
C0002965 (UMLS CUI [4])
C0027051 (UMLS CUI [5])
Bleeding tendency | Blood Coagulation Disorders | Anticoagulants Thromboembolism
Item
no bleeding diathesis or coagulopathy including concomitant use of anticoagulants for thromboembolic disease
boolean
C1458140 (UMLS CUI [1])
C0005779 (UMLS CUI [2])
C0003280 (UMLS CUI [3,1])
C0040038 (UMLS CUI [3,2])
Anticoagulant therapy | Antiplatelet Agents
Item
no active anticoagulant therapy (including antiplatelet agents) for at least ten days.
boolean
C0150457 (UMLS CUI [1])
C0085826 (UMLS CUI [2])
Bacterial Infection Uncontrolled | Virus Disease Uncontrolled | Mycoses Uncontrolled
Item
no active, uncontrolled bacterial, viral or fungal infection.
boolean
C0004623 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0042769 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0026946 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
Aprotinin allergy | Aprotinin allergy Expected | Aprotinin Received
Item
no patients who are known or expected to be allergic to aprotinin, or who have received prior aprotinin.
boolean
C0571793 (UMLS CUI [1])
C0571793 (UMLS CUI [2,1])
C1517001 (UMLS CUI [2,2])
C0003641 (UMLS CUI [3,1])
C1514756 (UMLS CUI [3,2])
Systolic Pressure chronic | Administration of intravenous fluids | Volume Intravascular Restore | Investigational New Drugs
Item
no patient with chronic systolic blood pressure (sbp) < 90 mm hg. if the (sbp) is < 90 mm hg on the day of treatment intravenous fluid may be administered to restore intravascular volume, if clinically indicated. in such case, if iv fluid corrects the sbp then the study drug may be given
boolean
C0871470 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0522792 (UMLS CUI [2])
C0005850 (UMLS CUI [3,1])
C0442123 (UMLS CUI [3,2])
C1283255 (UMLS CUI [3,3])
C0013230 (UMLS CUI [4])