Gender | Age
Item
1. female, age greater or equal to 20 years
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Breast Carcinoma
Item
2. patients with histologically or cytologically confirmed carcinoma of the breast
boolean
C0678222 (UMLS CUI [1])
Locally advanced breast cancer | Secondary malignant neoplasm of female breast
Item
3. patients with locally advance or metastatic carcinoma of the breast
boolean
C3495949 (UMLS CUI [1])
C0346993 (UMLS CUI [2])
Prior Chemotherapy Quantity | Anthracyclines | taxane | Therapeutic regimen Quantity Recurrent disease Locally | Therapeutic regimen Quantity Neoplasm Metastasis
Item
4. patients who have received two to five prior chemotherapeutic regimens including an antracycline and a taxane and 2 or more regimens for locally recurrent and/or metastatic disease
boolean
C1514457 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0282564 (UMLS CUI [2])
C0215136 (UMLS CUI [3])
C1276413 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C0277556 (UMLS CUI [4,3])
C1517927 (UMLS CUI [4,4])
C1276413 (UMLS CUI [5,1])
C1265611 (UMLS CUI [5,2])
C0027627 (UMLS CUI [5,3])
Unresponsive to Chemotherapy Recent
Item
5. patients must have proved refractory to the most recent chemotherapy on or within six (6) months of therapy
boolean
C0205269 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
Lesion Evaluable
Item
6. patients who have assessable lesion according to recist v 1.1
boolean
C0221198 (UMLS CUI [1,1])
C1516986 (UMLS CUI [1,2])
Bone Marrow function
Item
7. adequately maintained bone marrow function
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
Absolute neutrophil count
Item
absolute neutrophil count (anc) greater than or equal to 1.5 x 10^9 /l
boolean
C0948762 (UMLS CUI [1])
Hemoglobin measurement | Hemoglobin measurement Corrected Erythropoietin | Hemoglobin measurement Corrected Transfusion
Item
hemoglobin greater than or equal to 10.0 g/dl (a hemoglobin less than 10.0 g/dl is acceptable if it is corrected by erythropoietin or transfusion)
boolean
C0518015 (UMLS CUI [1])
C0518015 (UMLS CUI [2,1])
C0205202 (UMLS CUI [2,2])
C0014822 (UMLS CUI [2,3])
C0518015 (UMLS CUI [3,1])
C0205202 (UMLS CUI [3,2])
C0005841 (UMLS CUI [3,3])
Platelet Count measurement
Item
platelet count greater than or equal to 100 x 10^9 /l
boolean
C0032181 (UMLS CUI [1])
Liver function
Item
8. adequately maintained liver function
boolean
C0232741 (UMLS CUI [1])
Serum total bilirubin measurement
Item
total bilirubin: less than or equal to 1.5 times the upper limits of normal (uln) and
boolean
C1278039 (UMLS CUI [1])
Alkaline phosphatase measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Secondary malignant neoplasm of liver
Item
alkaline phosphatase(alp), alanine aminotransferase (alt), and aspartate aminotransferase (ast) less than or equal to 3 x uln (in the case of liver metastases less than or equal to 5 x uln)
boolean
C0201850 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0494165 (UMLS CUI [4])
Renal function
Item
9. adequately maintained renal function
boolean
C0232804 (UMLS CUI [1])
Creatinine measurement, serum
Item
serum creatinine less than or equal to 2.0 mg/dl or
boolean
C0201976 (UMLS CUI [1])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
calculated creatinine clearance greater than or equal to 40 ml/min (cockcroft and gault formula)
boolean
C2711451 (UMLS CUI [1])
Toxicity Chemotherapy Related | Toxicity Radiotherapy Related | Resolution CTCAE Grades
Item
10. resolution of all chemotherapy or radiation-related toxicities to grade 1 severity or lower, except for
boolean
C0600688 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0600688 (UMLS CUI [2,1])
C1522449 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
C1514893 (UMLS CUI [3,1])
C1516728 (UMLS CUI [3,2])
Exception Alopecia
Item
alopecia
boolean
C1705847 (UMLS CUI [1,1])
C0002170 (UMLS CUI [1,2])
Sensory neuropathy Stable CTCAE Grades
Item
stable sensory neuropathy less than or equal to grade 2
boolean
C0151313 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
ECOG performance status
Item
11. eastern cooperative oncology group (ecog) performance status of 0 to 2
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
12. life expectancy of greater than or equal to 3 months
boolean
C0023671 (UMLS CUI [1])
Protocol Compliance
Item
13. patients willing and able to comply with the study protocol for the duration of the study
boolean
C0525058 (UMLS CUI [1])
Informed Consent
Item
14. patients who have provided written consent to participate in this study
boolean
C0021430 (UMLS CUI [1])
Chemotherapy | Therapeutic radiology procedure | Biological Factors | Immunotherapy | Hormone Therapy | Palliative Radiation Therapy allowed
Item
1. patients who have received a chemotherapy, radiation, biologics, immunotherapy or hormonal therapy within three weeks before treatment start (but, palliative radiation can be enrolled)
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0005515 (UMLS CUI [3])
C0021083 (UMLS CUI [4])
C0279025 (UMLS CUI [5])
C3898008 (UMLS CUI [6,1])
C0683607 (UMLS CUI [6,2])
Lymphangitic metastasis to lung | Treatment required for Pulmonary Dysfunction | Use of supplemental oxygen
Item
2. pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen
boolean
C2062926 (UMLS CUI [1])
C0332121 (UMLS CUI [2,1])
C1709770 (UMLS CUI [2,2])
C4067893 (UMLS CUI [3])
Metastatic malignant neoplasm to brain | Neoplasm Metastasis Subdural | Exception Local Therapy Completed | Exception Corticosteroid use Discontinued
Item
3. patients with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least four weeks before starting treatment in this study. any signs and/or symptoms of brain metastases must be stable for at least four weeks before starting study treatment
boolean
C0220650 (UMLS CUI [1])
C0027627 (UMLS CUI [2,1])
C0038541 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1517925 (UMLS CUI [3,2])
C0205197 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0239126 (UMLS CUI [4,2])
C1444662 (UMLS CUI [4,3])
Meningeal Carcinomatosis
Item
4. patients with meningeal carcinomatosis
boolean
C0220654 (UMLS CUI [1])
Cardiovascular impairment
Item
5. significant cardiovascular impairment
boolean
C0848757 (UMLS CUI [1])
Myocardial Infarction | Angina, Unstable | Congestive heart failure New York Heart Association Classification | Cardiac Arrhythmia Serious
Item
myocardial infarction within the past six months, unstable angina, history of congestive heart failure nyha class iii or iv, or serious cardiac arrhythmia
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0018802 (UMLS CUI [3,1])
C1275491 (UMLS CUI [3,2])
C0003811 (UMLS CUI [4,1])
C0205404 (UMLS CUI [4,2])
Prolonged QTc Bazett formula | Congenital long QT syndrome
Item
qtc prolongation (bazett's formula greater than 480 msec) or congenital long qt syndrome
boolean
C1969409 (UMLS CUI [1,1])
C4038411 (UMLS CUI [1,2])
C1141890 (UMLS CUI [2])
Comorbidity Severe | Comorbidity Uncontrolled | Communicable Disease Requirement Antibiotic Injection
Item
6. severe/uncontrolled intercurrent illness/infection required administration of antibiotic injection
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0009488 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0009450 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0003232 (UMLS CUI [3,3])
C1533685 (UMLS CUI [3,4])
Major surgery
Item
7. patients who have processed a major surgery within four weeks before participation in this clinical trial
boolean
C0679637 (UMLS CUI [1])
Malignant Neoplasms | Exception Breast Carcinoma | Exception Skin carcinoma Treated | Exception Carcinoma in situ of uterine cervix Treated
Item
8. patients who have had a prior malignancy within the past five years other than breast cancer (but, treated non-melanoma skin cancer and carcinoma in situ of the cervix will not be excluded)
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0699893 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
HIV Seropositivity
Item
9. patients with known positive hiv status
boolean
C0019699 (UMLS CUI [1])
Gene therapy | Investigational New Drugs | Illicit medication use Expected
Item
10. patients who have received genetic therapy or other investigational drug within 4 weeks before treatment start or expected to receive prohibited medication
boolean
C0017296 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C0281875 (UMLS CUI [3,1])
C1517001 (UMLS CUI [3,2])
Hypersensitivity Halichondrin B | Hypersensitivity Halichondrin B Derivative | Hypersensitivity Halichondrin B Ingredient | Hypersensitivity Anticoagulants
Item
11. patients with prior allergies to halichondrin b, its derivatives, active ingredient, or other diluting agent
boolean
C0020517 (UMLS CUI [1,1])
C0120715 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0120715 (UMLS CUI [2,2])
C1527240 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0120715 (UMLS CUI [3,2])
C1550600 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0003280 (UMLS CUI [4,2])
halichondrin B
Item
12. patients who have received this investigational product before registration for this study
boolean
C0120715 (UMLS CUI [1])
Pregnancy | Possible pregnancy | Breast Feeding
Item
13. patients who are pregnant, who may possibly be pregnant, or are lactating
boolean
C0032961 (UMLS CUI [1])
C0425965 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Patients Contraceptive methods Unwilling
Item
14. patients who do not agree to practice contraception for the study periods
boolean
C0030705 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
Study Subject Participation Status
Item
15. patients who have participated in other clinical trial within 4 weeks before screening
boolean
C2348568 (UMLS CUI [1])
Study Subject Participation Status Inappropriate
Item
16. patients otherwise judged by investigator or sub investigator to be unsuitable for inclusion
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])