Age | Postmenopausal state | Amenorrhea Duration | Bilateral oophorectomy | Hysterectomy | Both ovaries Intact | Follicle stimulating hormone level Postmenopausal
Item
1. male subjects aged greater than or equal to 18 years and female subjects who must be postmenopausal (at least 12 months consecutive amenorrheic or have had a bilateral oophorectomy or, if they have had a hysterectomy but with ovaries intact, then females must be age 55 or older and with postmenopausal follicle-stimulating hormone [fsh] levels).
boolean
C0001779 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0002453 (UMLS CUI [3,1])
C0449238 (UMLS CUI [3,2])
C0278321 (UMLS CUI [4])
C0020699 (UMLS CUI [5])
C0227898 (UMLS CUI [6,1])
C0205266 (UMLS CUI [6,2])
C0202022 (UMLS CUI [7,1])
C0232970 (UMLS CUI [7,2])
Patient Appropriate Adjuvant Chemotherapy
Item
2. subject is a candidate for chemotherapy in the adjuvant setting.
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0085533 (UMLS CUI [1,3])
Start Adjuvant therapy | Operative Surgical Procedure Breast Carcinoma
Item
adjuvant therapy must begin within 84 days of the final surgical procedure for breast cancer.
boolean
C0439659 (UMLS CUI [1,1])
C0677850 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
Invasive carcinoma of breast TNM Breast tumor staging | Breast Carcinoma Synchronous Quantity
Item
3. histologically confirmed stage i to ii invasive breast cancer. subjects may have more than one synchronous primary breast tumor.
boolean
C0853879 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2,1])
C0439580 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Receptor status
Item
4. receptor status:
boolean
C0449443 (UMLS CUI [1])
HER2 Normal | HER2 FISH Negative | HER2 Immunohistochemistry
Item
her2-normal as determined by a negative fluorescence in situ hybridization (fish) result or 0 to 1+ by immunohistochemistry (ihc) staining result
boolean
C0069515 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C0069515 (UMLS CUI [2,1])
C0162789 (UMLS CUI [2,2])
C1513916 (UMLS CUI [2,3])
C0069515 (UMLS CUI [3,1])
C0021044 (UMLS CUI [3,2])
Estrogen receptor positive | Negative Lymph Node | Breast Carcinoma TNM Breast tumor staging Estrogen receptor positive Lymph node positive
Item
er-positive, node-negative or er-positive grade 1 or 2 node-positive breast cancer
boolean
C0279754 (UMLS CUI [1])
C0678034 (UMLS CUI [2])
C0678222 (UMLS CUI [3,1])
C0474926 (UMLS CUI [3,2])
C0279754 (UMLS CUI [3,3])
C0746319 (UMLS CUI [3,4])
ECOG performance status
Item
5. ecog performance status of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Renal function | Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
6. 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/min per 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 | Platelet Count measurement
Item
7. adequate bone marrow function as evidenced by anc greater than or equal to 1.5 x 10^9/l, hemoglobin greater than or equal to 10.0 g/dl, 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])
C0032181 (UMLS CUI [4])
Liver function | Serum total bilirubin measurement | Alkaline phosphatase measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement
Item
8. adequate liver function as evidenced by bilirubin less than or equal to 1.5 times the upper limits of normal (uln) and alkaline phosphatase, alanine aminotransferase (alt), and aspartate aminotransferase (ast) less than or equal to 3 x uln
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201850 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0201899 (UMLS CUI [5])
Gender | Vasectomy | Azoospermia | Partner Female infertility | Gender Contraceptive methods | Partner Contraceptive methods | Sexual Abstinence | Intrauterine Devices | Barrier Contraception Double | Condoms | Vaginal contraceptive diaphragm | Vaginal Spermicides
Item
9. male subjects must have had a successful vasectomy (confirmed azoospermia), or their female partners must not be of childbearing potential, or male subjects must agree to use and have their female partners use a highly effective method of contraception (e.g., total abstinence, an intrauterine device, a double-barrier method [such as condom plus diaphragm with spermicide] throughout the entire study period and for 30 days after study drug discontinuation..
boolean
C0079399 (UMLS CUI [1])
C0042387 (UMLS CUI [2])
C0004509 (UMLS CUI [3])
C0682323 (UMLS CUI [4,1])
C0021361 (UMLS CUI [4,2])
C0079399 (UMLS CUI [5,1])
C0700589 (UMLS CUI [5,2])
C0682323 (UMLS CUI [6,1])
C0700589 (UMLS CUI [6,2])
C0036899 (UMLS CUI [7])
C0021900 (UMLS CUI [8])
C0004764 (UMLS CUI [9,1])
C0205173 (UMLS CUI [9,2])
C0677582 (UMLS CUI [10])
C0042241 (UMLS CUI [11])
C0087145 (UMLS CUI [12])
Informed Consent | Protocol Compliance
Item
10. voluntary agreement to provide written informed consent and willingness and ability to comply with all aspects of the protocol
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Invasive carcinoma of breast TNM Breast tumor staging
Item
1. stage iii and iv invasive breast cancer
boolean
C0853879 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
Prior Chemotherapy Breast Carcinoma | Prior radiation therapy Breast Carcinoma | Prior Immunotherapy Breast Carcinoma | Biological treatment Breast Carcinoma
Item
2. prior chemotherapy, radiation therapy, immunotherapy or biotherapy for current breast cancer
boolean
C1514457 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0279134 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
C1514461 (UMLS CUI [3,1])
C0678222 (UMLS CUI [3,2])
C1531518 (UMLS CUI [4,1])
C0678222 (UMLS CUI [4,2])
Systemic disease Except Malignant Neoplasms | Cardiovascular Disease | Kidney Disease | Liver disease | Systemic disease Excludes Investigational New Drugs
Item
3. nonmalignant systemic disease (cardiovascular, renal, hepatic, etc) that would preclude any of the study therapy drugs
boolean
C0442893 (UMLS CUI [1,1])
C0332300 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
C0007222 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0023895 (UMLS CUI [4])
C0442893 (UMLS CUI [5,1])
C0332196 (UMLS CUI [5,2])
C0013230 (UMLS CUI [5,3])
Second Cancer | Exception Skin carcinoma Treated | Exception Carcinoma in situ of uterine cervix Treated
Item
4. subjects with a concurrently active second malignancy other than adequately treated nonmelanoma skin cancers or in situ cervical cancer
boolean
C0751623 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
Neuropathy Pre-existing CTCAE Grades
Item
5. subjects with pre-existing neuropathy greater than grade 2
boolean
C0442874 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
HIV Seropositivity
Item
6. subjects with known positive human immunodeficiency virus (hiv) status
boolean
C0019699 (UMLS CUI [1])
Childbearing Potential | Exception Postmenopausal state | Exception Amenorrhea Duration | Exception Bilateral oophorectomy | Exception Hysterectomy | Both ovaries Intact | Age | FSH level Postmenopausal
Item
7. females of childbearing potential. females will be considered to be of childbearing potential unless they are postmenopausal (at least 12 months consecutive amenorrheic or have had a bilateral oophorectomy or, if they have had a hysterectomy but with ovaries intact, then females must be age 55 or older and with postmenopausal fsh levels).
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])
C0449238 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0278321 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0020699 (UMLS CUI [5,2])
C0227898 (UMLS CUI [6,1])
C0205266 (UMLS CUI [6,2])
C0001779 (UMLS CUI [7])
C0202022 (UMLS CUI [8,1])
C0232970 (UMLS CUI [8,2])
Gastrointestinal Disease Intake Oral medication Unable | Gastrointestinal Diseases Absorption Oral medication Unable | Condition Intake Oral medication Unable | Condition Absorption Oral medication Unable
Item
8. subjects with current gastrointestinal disease or other condition resulting in an inability to take or absorb oral medications
boolean
C0017178 (UMLS CUI [1,1])
C1512806 (UMLS CUI [1,2])
C0175795 (UMLS CUI [1,3])
C1299582 (UMLS CUI [1,4])
C0017178 (UMLS CUI [2,1])
C0237442 (UMLS CUI [2,2])
C0175795 (UMLS CUI [2,3])
C1299582 (UMLS CUI [2,4])
C0348080 (UMLS CUI [3,1])
C1512806 (UMLS CUI [3,2])
C0175795 (UMLS CUI [3,3])
C1299582 (UMLS CUI [3,4])
C0348080 (UMLS CUI [4,1])
C0237442 (UMLS CUI [4,2])
C0175795 (UMLS CUI [4,3])
C1299582 (UMLS CUI [4,4])
Hypersensitivity Eribulin mesylate | Hypersensitivity Eribulin mesylate Excipient | Hypersensitivity Fluoropyrimidine | Dihydropyrimidine Dehydrogenase Deficiency | Dihydropyrimidine Dehydrogenase Deficiency Absent
Item
9. subjects with known allergy or hypersensitivity to eribulin mesylate or its excipients, or to fluoropyrimidine therapy (with or without documented dihydropyrimidine dehydrogenase [dpd] deficiency)
boolean
C0020517 (UMLS CUI [1,1])
C2608038 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C2608038 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0596581 (UMLS CUI [3,2])
C1959620 (UMLS CUI [4])
C1959620 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
Electrocardiogram abnormal | Prolonged QT interval | Prolonged QTc interval
Item
10. a clinically significant electrocardiogram (ecg) abnormality, including a marked baseline prolongation of qt/qtc interval (time between the start of the q wave and the end of the t wave/qt interval corrected for heart rate) (e.g., repeated demonstration of a qtc interval greater than 500 ms)
boolean
C0522055 (UMLS CUI [1])
C0151878 (UMLS CUI [2])
C1560305 (UMLS CUI [3])
Medical condition Study Subject Participation Status Excluded | Condition Study Subject Participation Status Excluded
Item
11. any medical or other condition which, in the opinion of the investigator, would preclude participation in a clinical trial
boolean
C3843040 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])