Breast Carcinoma | Inflammatory Breast Carcinoma | Erythema diffuse | Edema | Peau d'orange surface of breast | Breast palpable mass | Breast palpable mass Absent | Lymphatic Invasion Dermal
Item
1. patients must have histologically or cytologically confirmed breast carcinoma with a clinical diagnosis of ibc based on the presence of inflammatory changes in the involved breast, such as diffuse erythema and edema (peau d'orange), with or without an underlying palpable mass involving the majority of the skin of the breast. pathological evidence of dermal lymphatic invasion should be noted but is not required for diagnosis.
boolean
C0678222 (UMLS CUI [1])
C0278601 (UMLS CUI [2])
C0858689 (UMLS CUI [3])
C0013604 (UMLS CUI [4])
C0425791 (UMLS CUI [5])
C1403543 (UMLS CUI [6])
C1403543 (UMLS CUI [7,1])
C0332197 (UMLS CUI [7,2])
C1708790 (UMLS CUI [8,1])
C0221928 (UMLS CUI [8,2])
Measurable lesion Quantity | Measurable lesion Dimension Quantity | Non-Measurable Lesion
Item
2. patients may have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension in accordance with recist criteria v. 1.1 as described in detail in section 11.0 or non-measurable tumors
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1513041 (UMLS CUI [2,1])
C0439534 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C1334988 (UMLS CUI [3])
Neoplasm Metastasis | Systemic therapy Line Quantity Neoplasm Metastasis
Item
3. patients must have demonstrated metastatic disease and not received >2 lines of systemic therapy for metastatic disease
boolean
C0027627 (UMLS CUI [1])
C1515119 (UMLS CUI [2,1])
C4524693 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0027627 (UMLS CUI [2,4])
Age
Item
4. age > 18 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
5. ecog performance status 0, 1 or 2
boolean
C1520224 (UMLS CUI [1])
Organ function | Bone Marrow function | White Blood Cell Count procedure | Absolute neutrophil count | Hemoglobin measurement | Platelet Count measurement | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement | Secondary malignant neoplasm of bone | Secondary malignant neoplasm of liver Absent | Serum magnesium measurement | Creatinine measurement, serum | Serum potassium measurement
Item
6. patients must have normal organ and marrow function as defined below: a) leukocytes > 2,500/mcl b) absolute neutrophil count > 1,500/mcl c) hemoglobin > 9 g/dl d) platelets > 100,000/mcl e) total bilirubin < 1.5 mg/dl f) ast/alt (sgot/sgpt) < 2.5 x uln g) alkaline phosphatase < 2.5 x uln (unless bone metastasis is present in the absence of liver metastasis, in which case 3.0 x uln would be acceptable. h) serum magnesium > 1.8 mg/dl i) serum creatinine < 1.5 mg/dl j) serum potassium > 3.8 mmol/l
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
C0023508 (UMLS CUI [3])
C0948762 (UMLS CUI [4])
C0518015 (UMLS CUI [5])
C0032181 (UMLS CUI [6])
C1278039 (UMLS CUI [7])
C0201899 (UMLS CUI [8])
C0201836 (UMLS CUI [9])
C0201850 (UMLS CUI [10])
C0153690 (UMLS CUI [11])
C0494165 (UMLS CUI [12,1])
C0332197 (UMLS CUI [12,2])
C0202125 (UMLS CUI [13])
C0201976 (UMLS CUI [14])
C0302353 (UMLS CUI [15])
Tumor HER2 Negative Immunohistochemistry | Tumor FISH test Negative
Item
7. tumor negative for her2 expression (0 or 1+ by ihc) or negative fish testing
boolean
C0027651 (UMLS CUI [1,1])
C2348908 (UMLS CUI [1,2])
C0021044 (UMLS CUI [1,3])
C0027651 (UMLS CUI [2,1])
C0162789 (UMLS CUI [2,2])
C1513916 (UMLS CUI [2,3])
Life Expectancy
Item
8. patients must have a life expectancy of at least 12 weeks
boolean
C0023671 (UMLS CUI [1])
Effects of Prior surgery | Effects of Prior radiation therapy | Effects of Antineoplastic Drug/Agent Therapy | Patient recovered
Item
9. patients must be recovered from the effects of any prior surgery, radiotherapy, or other antineoplastic therapy
boolean
C1704420 (UMLS CUI [1,1])
C0455610 (UMLS CUI [1,2])
C1704420 (UMLS CUI [2,1])
C0279134 (UMLS CUI [2,2])
C1704420 (UMLS CUI [3,1])
C2346834 (UMLS CUI [3,2])
C1115804 (UMLS CUI [4])
Peripheral Neuropathy Pre-existing CTCAE Grades
Item
10. patients must have < grade 2 pre-existing peripheral neuropathy per ctcae
boolean
C0031117 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
Childbearing Potential Contraceptive methods | Gender Sexually active Contraceptive methods
Item
11. women of childbearing potential and sexually active males must use an effective contraception method during treatment and for three months after completing treatment
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0241028 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
Childbearing Potential Serum pregnancy test (B-HCG) Negative | Childbearing Potential Urine pregnancy test negative HCG beta
Item
12. negative serum or urine β-hcg pregnancy test at screening, performed no more than 72 hours prior to treatment initiation; for patients of childbearing potential
boolean
C3831118 (UMLS CUI [1,1])
C0430060 (UMLS CUI [1,2])
C1513916 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0430057 (UMLS CUI [2,2])
C0106132 (UMLS CUI [2,3])
Informed Consent
Item
13. ability to understand and willingness to sign a written informed consent and hipaa consent document
boolean
C0021430 (UMLS CUI [1])
Chemotherapy Recent | Therapeutic radiology procedure Recent | Adverse reaction to drug | Recovery Lacking
Item
1. patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse event from agents administered more than 4 weeks earlier
boolean
C0392920 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C0041755 (UMLS CUI [3])
C2004454 (UMLS CUI [4,1])
C0332268 (UMLS CUI [4,2])
Investigational New Drugs | Antineoplastic Drug/Agent Therapy
Item
2. patients may not be receiving any other investigational agents or active anti-neoplastic therapies
boolean
C0013230 (UMLS CUI [1])
C2346834 (UMLS CUI [2])
romidepsin | Abraxane
Item
3. patients who have previously received romidepsin or abraxane
boolean
C1527027 (UMLS CUI [1])
C1564985 (UMLS CUI [2])
Metastatic malignant neoplasm to brain untreated | Metastatic malignant neoplasm to brain Uncontrolled | Leptomeningeal disease untreated | Leptomeningeal disease Uncontrolled
Item
4. patients with untreated or uncontrolled brain metastases or leptomeningeal disease
boolean
C0220650 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0220650 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0751297 (UMLS CUI [3,1])
C0332155 (UMLS CUI [3,2])
C0751297 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
Hypersensitivity Component Romidepsin | Paclitaxel allergy
Item
5. patients with known hypersensitivity to any of the components of romidepsin or who have had hypersensitivity reactions to paclitaxel
boolean
C0020517 (UMLS CUI [1,1])
C1705248 (UMLS CUI [1,2])
C1527027 (UMLS CUI [1,3])
C0570707 (UMLS CUI [2])
Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
Item
6. uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0742758 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
C0004936 (UMLS CUI [6,1])
C0439801 (UMLS CUI [6,2])
C0525058 (UMLS CUI [6,3])
C0748872 (UMLS CUI [7,1])
C0439801 (UMLS CUI [7,2])
C0525058 (UMLS CUI [7,3])
Cardiac abnormality
Item
7. any known cardiac abnormalities such as:
boolean
C0018798 (UMLS CUI [1])
Congenital long QT syndrome
Item
1. congenital long qt syndrome
boolean
C1141890 (UMLS CUI [1])
Prolonged QTc interval
Item
2. qtc interval ≥ 500 milliseconds
boolean
C1560305 (UMLS CUI [1])
Myocardial Infarction
Item
3. myocardial infarction within 6 months of c1d1. subjects with a history of myocardial infarction between 6 and 12 months prior to c1d1 who are asymptomatic and have had a negative cardiac risk assessment (treadmill stress test, nuclear medicine stress test, or stress echocardiogram) since the event may participate
boolean
C0027051 (UMLS CUI [1])
ECG abnormal | Second degree atrioventricular block | Complete atrioventricular block | Bradycardia | Ventricular Heart Rate
Item
4. other significant ekg abnormalities including 2nd degree atrio-ventricular (av) block type ii, 3rd degree av block, or bradycardia (ventricular rate less than 50 beats/min)
boolean
C0522055 (UMLS CUI [1])
C0264906 (UMLS CUI [2])
C0151517 (UMLS CUI [3])
C0428977 (UMLS CUI [4])
C1883530 (UMLS CUI [5])
Coronary Artery Disease Symptomatic | Angina Pectoris Canadian Cardiovascular Society classification of angina
Item
5. symptomatic coronary artery disease (cad), e.g., angina canadian class ii-iv (see appendix iii) in any patient in whom there is doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not cad is present
boolean
C1956346 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0002962 (UMLS CUI [2,1])
C1277207 (UMLS CUI [2,2])
Myocardial Ischemia ECG | ST segment depression ECG
Item
6. an ekg recorded at screening showing evidence of cardiac ischemia (st depression depression of ≥2 mm, measured from isoelectric line to the st segment). if in any doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not cad is present
boolean
C0151744 (UMLS CUI [1,1])
C1623258 (UMLS CUI [1,2])
C0520887 (UMLS CUI [2,1])
C1623258 (UMLS CUI [2,2])
Congestive heart failure New York Heart Association Classification | Cardiac ejection fraction MUGA scan | Cardiac ejection fraction Echocardiography | Cardiac ejection fraction MRI
Item
7. congestive heart failure (chf) that meets new york heart association (nyha) class ii to iv definitions (see appendix iv) and/or known ejection fraction <40% by muga or <50% by echocardiogram and/ormri
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0232174 (UMLS CUI [2,1])
C0521317 (UMLS CUI [2,2])
C0232174 (UMLS CUI [3,1])
C0013516 (UMLS CUI [3,2])
C0232174 (UMLS CUI [4,1])
C0024485 (UMLS CUI [4,2])
Sustained ventricular tachycardia | Ventricular Fibrillation | Torsades de Pointes | Cardiac Arrest | Exception Automatic Implantable Cardioverter-Defibrillator
Item
8. a known history of sustained ventricular tachycardia (vt), ventricular fibrillation (vf), torsade de pointes, or cardiac arrest unless currently addressed with an automatic implantable cardioverter defibrillator (aicd)
boolean
C0750197 (UMLS CUI [1])
C0042510 (UMLS CUI [2])
C0040479 (UMLS CUI [3])
C0018790 (UMLS CUI [4])
C1705847 (UMLS CUI [5,1])
C0972395 (UMLS CUI [5,2])
Hypertrophic cardiomegaly Due to Prior Therapy | Restrictive cardiomyopathy Due to Prior Therapy
Item
9. hypertrophic cardiomegaly or restrictive cardiomyopathy from prior treatment or other causes
boolean
C2733179 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C1514463 (UMLS CUI [1,3])
C0007196 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C1514463 (UMLS CUI [2,3])
Uncontrolled hypertension | Blood pressure determination
Item
10. uncontrolled hypertension, i.e., blood pressure (bp) of ≥ 160/95; patients who have a history of hypertension controlled by medication must be on a stable dose (for at least one month) and meet all other inclusion criteria
boolean
C1868885 (UMLS CUI [1])
C0005824 (UMLS CUI [2])
Cardiac Arrhythmia Requirement Anti-Arrhythmia Agents | Exception Adrenergic beta-1 Receptor Antagonists Dose Stable
Item
11. any cardiac arrhythmia requiring an anti-arrhythmic medication (excluding stable doses of beta-blockers)
boolean
C0003811 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0003195 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0304516 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C0205360 (UMLS CUI [2,4])
Pharmaceutical Preparations Causing Prolonged QT interval
Item
12. patients taking drugs leading to significant qt prolongation (see appendix i: medications that may cause qtc prolongation)
boolean
C0013227 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0151878 (UMLS CUI [1,3])
CYP3A4 Inhibitors
Item
13. concomitant use of cyp3a4 inhibitors (see appendix ii)
boolean
C3850053 (UMLS CUI [1])
HIV Infection | Hepatitis B | Hepatitis C
Item
8. patients with known hiv, hepatitis b or c (however, if patients have previously been treated for hepatitis b or c and have undetectable viral loads, they can be considered eligible for trial)
boolean
C0019693 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
9. pregnant or breast feeding. refer to section 4.4 for further detail
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Other medical condition Interferes with Informed Consent | Mental condition Interferes with Informed Consent | Other medical condition Interferes with Protocol Compliance | Mental condition Interferes with Protocol Compliance | Other medical condition Interferes with Study Subject Participation Status | Mental condition Interferes with Study Subject Participation Status | Other medical condition Interferes with Interpretation Research results | Mental condition Interferes with Interpretation Research results
Item
10. patients with any other medical or psychological condition deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C3840291 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
C3840291 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
C3843040 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C2348568 (UMLS CUI [5,3])
C3840291 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C2348568 (UMLS CUI [6,3])
C3843040 (UMLS CUI [7,1])
C0521102 (UMLS CUI [7,2])
C0459471 (UMLS CUI [7,3])
C0683954 (UMLS CUI [7,4])
C3840291 (UMLS CUI [8,1])
C0521102 (UMLS CUI [8,2])
C0459471 (UMLS CUI [8,3])
C0683954 (UMLS CUI [8,4])