Breast adenocarcinoma
Item
1. histological or cytological adenocarcinoma of the breast
boolean
C0858252 (UMLS CUI [1])
Gender | Age
Item
2. females, aged greater than or equal to 18 years at time of informed consent
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
HER2 Negative FISH
Item
3. her2-negative as determined by fluorescence in situ hybridization (fish); or 0 or 1+
boolean
C2348908 (UMLS CUI [1,1])
C0162789 (UMLS CUI [1,2])
HER2 Negative Immunohistochemistry
Item
by immunohistochemistry (ihc) staining
boolean
C2348908 (UMLS CUI [1,1])
C0021044 (UMLS CUI [1,2])
Secondary malignant neoplasm of female breast | Prior Chemotherapy Quantity
Item
4. participants with metastatic breast cancer who have received at least 2 and not more than 5 prior chemotherapy regimens
boolean
C0346993 (UMLS CUI [1])
C1514457 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Measurable lesion Quantity Longest Diameter | Exception Lymph node | Measurable lesion Lymph node Short axis Diameter
Item
5. participants with at least one measurable lesion greater than or equal to 10 mm in the longest diameter for a non-lymph node or greater than or equal to 15 mm in the short-axis diameter for a lymph node as determined by investigator using response evaluation criteria in solid tumors version 1.1 (recist v1.1)
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0552406 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0024204 (UMLS CUI [2,2])
C1513041 (UMLS CUI [3,1])
C0024204 (UMLS CUI [3,2])
C0522488 (UMLS CUI [3,3])
C1301886 (UMLS CUI [3,4])
ECOG performance status
Item
6. eastern cooperative oncology group (ecog) performance status less than or equal to 2
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
7. life expectancy of greater than or equal to 3 months
boolean
C0023671 (UMLS CUI [1])
Neuropathy CTCAE Grades
Item
8. any neuropathy must recover to grade less than or equal to 2 prior to enrollment
boolean
C0442874 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Renal function | Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
9. adequate renal function as evidenced by serum creatinine less than or equal to 1.5 mg/dl or calculated creatinine clearance greater than or equal to 50 ml/minute according to the cockcroft and gault formula
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C2711451 (UMLS CUI [3])
Bone Marrow function | Absolute neutrophil count | Hemoglobin measurement | Hemoglobin measurement Growth Factor Corrected | Hemoglobin measurement Transfusion Corrected | Platelet Count measurement
Item
10. adequate bone marrow function as evidenced by absolute neutrophil count (anc) greater than or equal to 1.5 x 10^9/l, hemoglobin greater than or equal to 10.0 g/dl (can be corrected by growth factor or transfusion), and platelet count greater than or equal to 100 x 10^9/l
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
C0518015 (UMLS CUI [4,1])
C0018284 (UMLS CUI [4,2])
C0205202 (UMLS CUI [4,3])
C0518015 (UMLS CUI [5,1])
C1879316 (UMLS CUI [5,2])
C0205202 (UMLS CUI [5,3])
C0032181 (UMLS CUI [6])
Liver function | Serum total bilirubin measurement | Alkaline phosphatase measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Relationship Secondary malignant neoplasm of liver | Relationship Secondary malignant neoplasm of bone
Item
11. adequate liver function as evidenced by total bilirubin less than or equal to 1.5 x upper limit of normal (uln), alkaline phosphatase, alanine aminotransferase (alt), and aspartate aminotransferase (ast) less than or equal to 3 x uln (less than or equal to 5 x uln in the case of liver metastases), unless there are bone metastases, in which case liver specific alkaline phosphatase must be separated from the total and used to assess the liver function instead of the total alkaline phosphatase
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201850 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0201899 (UMLS CUI [5])
C0439849 (UMLS CUI [6,1])
C0494165 (UMLS CUI [6,2])
C0439849 (UMLS CUI [7,1])
C0153690 (UMLS CUI [7,2])
Protocol Compliance
Item
12. are willing and able to comply with all aspects of the treatment protocol
boolean
C0525058 (UMLS CUI [1])
Informed Consent
Item
13. provide written informed consent
boolean
C0021430 (UMLS CUI [1])
Prior Therapy Eribulin
Item
1. previous treatment with eribulin
boolean
C1514463 (UMLS CUI [1,1])
C2350866 (UMLS CUI [1,2])
Hypersensitivity Eribulin | Hypersensitivity Eribulin Pharmaceutical Excipient | Hypersensitivity Halichondrin B | Intolerance to eribulin
Item
2. hypersensitivity to eribulin/excipients or halichondrin b or known intolerance of eribulin
boolean
C0020517 (UMLS CUI [1,1])
C2350866 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C2350866 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0120715 (UMLS CUI [3,2])
C1744706 (UMLS CUI [4,1])
C2350866 (UMLS CUI [4,2])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
3. current enrollment in another clinical study or used of any investigational drug or device within the past 28 days preceding informed consent
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
Prior Chemotherapy | Prior radiation therapy | Biological treatment | Targeted Therapy
Item
4. previous treatment with chemotherapy, radiation, biological, or targeted therapy within the last 2 weeks or 5 x half-life, whichever is longer, preceding informed consent
boolean
C1514457 (UMLS CUI [1])
C0279134 (UMLS CUI [2])
C1531518 (UMLS CUI [3])
C2985566 (UMLS CUI [4])
Breast Feeding | Pregnancy | Serum Beta-HCG Test Positive
Item
5. females who are breastfeeding or pregnant at screening or baseline (as documented by a positive beta-human chorionic gonadotropin ([b-hcg] test). a separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C1255526 (UMLS CUI [3,1])
C1514241 (UMLS CUI [3,2])
Childbearing Potential | Exception Postmenopausal state | Exception Amenorrhea | Exception Female Sterilization | Bilateral tubal ligation | Total hysterectomy | Bilateral oophorectomy
Item
6. all females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (ie, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing)
boolean
C3831118 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0232970 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0002453 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0015787 (UMLS CUI [4,2])
C0589114 (UMLS CUI [5])
C0677962 (UMLS CUI [6])
C0278321 (UMLS CUI [7])
Childbearing Potential Sexual intercourse | Childbearing Potential Contraceptive methods Unwilling | Total abstinence | Intrauterine Devices | Barrier Contraception Double | Female Condoms | Vaginal contraceptive diaphragm | Vaginal Spermicides | Contraceptive implant | Contraceptives, Oral | Partner had vasectomy | Partner Azoospermia
Item
7. females of childbearing potential who had unprotected sexual intercourse within 30 days before study entry and who do not agree to use a highly effective method of contraception (eg, total abstinence, an intrauterine device, a double-barrier method [such as condom plus diaphragm with spermicide], a contraceptive implant, an oral contraceptive, or have a vasectomized partner with confirmed azoospermia) throughout the entire study period or for 28 days after study drug discontinuation.
boolean
C3831118 (UMLS CUI [1,1])
C0009253 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
C0234008 (UMLS CUI [3])
C0021900 (UMLS CUI [4])
C0004764 (UMLS CUI [5,1])
C0205173 (UMLS CUI [5,2])
C0221829 (UMLS CUI [6])
C0042241 (UMLS CUI [7])
C0087145 (UMLS CUI [8])
C1657106 (UMLS CUI [9])
C0009905 (UMLS CUI [10])
C0420842 (UMLS CUI [11])
C0682323 (UMLS CUI [12,1])
C0004509 (UMLS CUI [12,2])
Gender Sexual Abstinence | Barrier Contraception Double Unwilling | Avoidance Sexual activity Rejected
Item
females who are currently abstinent and do not agree to use a double barrier method as described above or to refrain from sexual activity during the study period or for 28 days after study drug discontinuation.
boolean
C0079399 (UMLS CUI [1,1])
C0036899 (UMLS CUI [1,2])
C0004764 (UMLS CUI [2,1])
C0205173 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
C0870186 (UMLS CUI [3,1])
C0036864 (UMLS CUI [3,2])
C1548437 (UMLS CUI [3,3])
Gender | Use of Hormonal Oral Contraceptives | Hormonal Oral Contraceptive Dose Stable Lacking | Rejection Use of Hormonal Oral Contraceptive Same
Item
females who are using hormonal contraceptives but are not on a stable dose of the same hormonal contraceptive product for at least 4 weeks before dosing and who do not agree to use the same contraceptive during the study or for 28 days after study drug discontinuation.
boolean
C0079399 (UMLS CUI [1])
C1524063 (UMLS CUI [2,1])
C0009907 (UMLS CUI [2,2])
C0009907 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
C0332268 (UMLS CUI [3,4])
C1548437 (UMLS CUI [4,1])
C1524063 (UMLS CUI [4,2])
C0009907 (UMLS CUI [4,3])
C0445247 (UMLS CUI [4,4])
CNS disorder | Exception Metastatic malignant neoplasm to brain Treated | Exception Patient's condition stable | Exception Disease Progression Absent | Exception Hemorrhage Absent | Exception Adrenal Cortex Hormones Absent
Item
8. known central nervous system (cns) disease, except for those participants with treated brain metastasis who are stable for at least 1 month with no evidence of progression or hemorrhage after treatment and no ongoing requirement for corticosteroids
boolean
C0007682 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0220650 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1282982 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0242656 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0019080 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0001617 (UMLS CUI [6,2])
C0332197 (UMLS CUI [6,3])
HIV Seropositivity
Item
9. known human immunodeficiency virus (hiv) positive
boolean
C0019699 (UMLS CUI [1])
Cancer treatment | Therapy-Related Toxicity CTCAE Grades | Exception Alopecia
Item
10. existing anticancer, therapy-related toxicities of grades greater than or equal to 2, with the exception of alopecia
boolean
C0920425 (UMLS CUI [1])
C1710382 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0002170 (UMLS CUI [3,2])
Malignant Neoplasm Previous | Exception Carcinoma in situ of uterine cervix | Exception Skin carcinoma | Exception Malignant Neoplasms Treated | Exception Recurrence Absent
Item
11. a prior malignancy other than carcinoma in situ of the cervix, or nonmelanoma skin cancer, unless the prior malignancy was diagnosed and definitively treated greater than 5 years previously with no subsequent evidence of recurrence
boolean
C0006826 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0699893 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0006826 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C2825055 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
Cardiovascular impairment | Congestive heart failure New York Heart Association Classification | Angina, Unstable | Myocardial Infarction | Cardiac Arrhythmia Serious
Item
12. clinically significant cardiovascular impairment (congestive heart failure of new york heart association [nyha] classification greater than ii, unstable angina, myocardial infarction within the past 6 months, or serious cardiac arrhythmia)
boolean
C0848757 (UMLS CUI [1])
C0018802 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C0002965 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
C0003811 (UMLS CUI [5,1])
C0205404 (UMLS CUI [5,2])
ECG abnormal | Prolonged QT interval | Prolonged QTc interval
Item
13. clinically significant ecg abnormality, including a marked baseline prolonged qt/qtc interval (ie, a repeated demonstration of a qtc interval greater than 500 milliseconds)
boolean
C0522055 (UMLS CUI [1])
C0151878 (UMLS CUI [2])
C1560305 (UMLS CUI [3])
Lymphangitic metastasis to lung Resulting in Pulmonary Dysfunction | Requirement Therapeutic procedure | Requirement Use of supplemental oxygen
Item
14. pulmonary lymphangitic involvement that resulted in pulmonary dysfunction requiring active treatment, including the use of oxygen
boolean
C2062926 (UMLS CUI [1,1])
C0332294 (UMLS CUI [1,2])
C1709770 (UMLS CUI [1,3])
C1514873 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C1514873 (UMLS CUI [3,1])
C4067893 (UMLS CUI [3,2])
Comorbidity compromises Completion of clinical trial
Item
15. history of concomitant medical condition(s) that, in the opinion of the investigator, would compromise the participant's ability to safely complete the study
boolean
C0009488 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
Study Subject Medically unfit Eribulin | Study Subject Participation Status Inappropriate
Item
16. the investigator's belief that the participant is medically unfit to receive eribulin or unsuitable for any other reason
boolean
C0681850 (UMLS CUI [1,1])
C3841806 (UMLS CUI [1,2])
C2350866 (UMLS CUI [1,3])
C2348568 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])