Breast Carcinoma | Metastatic malignant neoplasm to brain
Item
1. patients must have histologically proven breast cancer with metastatic disease to the brain.
boolean
C0678222 (UMLS CUI [1])
C0220650 (UMLS CUI [2])
Measurable Disease MRI | Progressive Disease | Status post Prior Therapy | Measurable Disease Vertical diameter MRI gadolinium-enhanced | New Lesion Identification Scan | Worsening Clinical | Worsening Neurologic | Stable Disease
Item
2. patients must have measurable disease on mri that has progressed after prior therapy. pd will be defined as a>/= 25% increase in the sum of the products of greatest perpendicular diameters of all measurable disease over the smallest sum observed (since treatment started) on gd-mri, the appearance of new lesions on scan, or clinical or neurologic worsening despite stable disease on the last 2 scans.
boolean
C1513041 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C1335499 (UMLS CUI [2])
C0231290 (UMLS CUI [3,1])
C1514463 (UMLS CUI [3,2])
C1513041 (UMLS CUI [4,1])
C4067892 (UMLS CUI [4,2])
C0855566 (UMLS CUI [4,3])
C2986548 (UMLS CUI [5,1])
C0441633 (UMLS CUI [5,2])
C0332271 (UMLS CUI [6,1])
C0205210 (UMLS CUI [6,2])
C0332271 (UMLS CUI [7,1])
C0205494 (UMLS CUI [7,2])
C0677946 (UMLS CUI [8])
Operative Surgical Procedures Previous Quantity | Prior radiation therapy Quantity | Prior Chemotherapy Quantity | Adjuvant therapy Disease | Neoadjuvant Therapy Disease | Palliative Care Disease
Item
3. patients may have had any number of prior surgeries, radiation and/or chemotherapy regimens as adjuvant, neoadjuvant or palliative therapy for the treatment of their disease
boolean
C0543467 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0279134 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1514457 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0677850 (UMLS CUI [4,1])
C0012634 (UMLS CUI [4,2])
C0600558 (UMLS CUI [5,1])
C0012634 (UMLS CUI [5,2])
C0030231 (UMLS CUI [6,1])
C0012634 (UMLS CUI [6,2])
Age
Item
4. patients must be >/=18 years of age.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
5. patients must have an ecog performance status of 0,1 or 2.
boolean
C1520224 (UMLS CUI [1])
Bone Marrow function | Absolute neutrophil count | Platelet Count measurement | Renal function | Creatinine measurement, serum
Item
6. patients must have adequate bone marrow function as evidenced by an absolute neutrophil count >/=1,500/microliters and a platelet count >/=100,000/microliter, adequate renal function as evidenced by serum creatinine </=2.0 mg/dl, adequate hepatic function as evidenced by serum total bilirubin </=2.0 mg/dl, ast/sgot and alt/sgpt </= 3x the uln.
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0232804 (UMLS CUI [4])
C0201976 (UMLS CUI [5])
Effects of Operative Surgical Procedure Previous | Patient recovered | Prior Chemotherapy | Recovery White Blood Cell Count procedure | Recovery Platelet Count measurement | Therapeutic radiology procedure Completed | Exception New Lesion Identification Imaging
Item
7. patients must have recovered and healed from the effects of any prior surgery, must have received prior chemotherapy at least 2 weeks prior to dosing with adequate recovery of wbc and platelet counts, and at least 12 weeks must have elapsed from the completion of radiotherapy, unless there are new lesions appearing on imaging within this 12 weeks frame.
boolean
C1704420 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
C1115804 (UMLS CUI [2])
C1514457 (UMLS CUI [3])
C0237820 (UMLS CUI [4,1])
C0023508 (UMLS CUI [4,2])
C0237820 (UMLS CUI [5,1])
C0032181 (UMLS CUI [5,2])
C1522449 (UMLS CUI [6,1])
C0205197 (UMLS CUI [6,2])
C1705847 (UMLS CUI [7,1])
C2986548 (UMLS CUI [7,2])
C0011923 (UMLS CUI [7,3])
Childbearing Potential Urine pregnancy test negative | Childbearing Potential Serum pregnancy test negative | Age | Menstrual cycle | Follicle stimulating hormone measurement | Luteinizing hormone measurement | Estradiol measurement
Item
8. women of child-bearing potential (i.e. </= 50 years of age or has had menstrual cycle within the past 12 months, if > 50 years of age. if in doubt, check fsh, lh and estradiol level) must have a negative urine or serum pregnancy test at screening.
boolean
C3831118 (UMLS CUI [1,1])
C0430057 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430061 (UMLS CUI [2,2])
C0001779 (UMLS CUI [3])
C0025329 (UMLS CUI [4])
C0202022 (UMLS CUI [5])
C0202123 (UMLS CUI [6])
C0337434 (UMLS CUI [7])
Patients Sexually active Contraceptive methods | Sexual Abstinence | Contraception, Barrier
Item
9. sexually active patients must agree to use adequate contraception (abstinence or barrier contraceptives must be used throughout the trial and one month after end of treatment) for the duration of the study .
boolean
C0030705 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
C0036899 (UMLS CUI [2])
C0004764 (UMLS CUI [3])
Informed Consent | Informed Consent Patient Representative
Item
10. patients or their legal representative must be able to read, understand and sign an informed consent form (icf).
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
TPI-287 Interferes with Coumadin Dose | Requirement Monitoring Prothrombin time assay | Requirement Monitoring Activated Partial Thromboplastin Time measurement | Requirement Monitoring International Normalized Ratio
Item
11. tpi 287 may interfere with coumadin dosing and patients who are taking this combination will require monitoring of their pt, ptt and inr.
boolean
C1710314 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0699129 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,4])
C1514873 (UMLS CUI [2,1])
C0030695 (UMLS CUI [2,2])
C0033707 (UMLS CUI [2,3])
C1514873 (UMLS CUI [3,1])
C0030695 (UMLS CUI [3,2])
C0030605 (UMLS CUI [3,3])
C1514873 (UMLS CUI [4,1])
C0030695 (UMLS CUI [4,2])
C0525032 (UMLS CUI [4,3])
Antiepileptic Agents Inducing Enzymes | Carbamazepine | oxcarbazepine | Phenytoin | fosphenytoin | Phenobarbital | Primidone
Item
1. patients who are receiving concurrent enzyme-inducing anti-epileptic drugs (eiaeds) (e.g., carbamazepine, oxcarbazepine, phenytoin, fosphenytoin, phenobarbital and primidone) or who received eiaeds within 2 weeks prior to the first dose of study drug.
boolean
C0003299 (UMLS CUI [1,1])
C0205263 (UMLS CUI [1,2])
C0014442 (UMLS CUI [1,3])
C0006949 (UMLS CUI [2])
C0069751 (UMLS CUI [3])
C0031507 (UMLS CUI [4])
C0244656 (UMLS CUI [5])
C0031412 (UMLS CUI [6])
C0033148 (UMLS CUI [7])
Intracranial Hypertension Uncontrolled | Persistent headache | Visual obscuration Transient | Diplopia | Disease Management Optimal | Seizure Uncontrolled
Item
2. patients with uncontrolled intracranial hypertension syndrome (defined as: persistence of headache, transient visual obscurations, and/or diplopia despite optimal clinical management) or uncontrolled seizure activity (i.e. recorded despite optimal medical management).
boolean
C0151740 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0744648 (UMLS CUI [2])
C1321318 (UMLS CUI [3,1])
C0205374 (UMLS CUI [3,2])
C0012569 (UMLS CUI [4])
C0376636 (UMLS CUI [5,1])
C2698651 (UMLS CUI [5,2])
C0036572 (UMLS CUI [6,1])
C0205318 (UMLS CUI [6,2])
Steroids Dose Unstable | Steroids Dose Decreasing
Item
3. patients who are not on a stable or decreasing steroid dose for the previous week prior to the first dose of study enrollment
boolean
C0038317 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0443343 (UMLS CUI [1,3])
C0038317 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0442797 (UMLS CUI [2,3])
bevacizumab | Therapeutic procedure Metastatic malignant neoplasm to brain
Item
4. patients who are taking bevacizumab or have taken bevacizumab within the past 2 weeks for treatment of their brain metastases
boolean
C0796392 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0220650 (UMLS CUI [2,2])
Communicable Disease | Sign or Symptom Hemorrhage | Sign or Symptom Infectious Skin Diseases Pustules | Cough Associated with Fever | Antibiotics | Fever
Item
5. patients with an active infection (i.e., clinical signs or symptoms, including, but not limited to: bleeding/pustulant skin infections; productive cough associated with fever) on antibiotics or with a fever >/=38.5°c within 3 days prior to registration (i.e. date when the patient signs the consent and/or the patient is registered in core).
boolean
C0009450 (UMLS CUI [1])
C3540840 (UMLS CUI [2,1])
C0019080 (UMLS CUI [2,2])
C3540840 (UMLS CUI [3,1])
C0037278 (UMLS CUI [3,2])
C0241157 (UMLS CUI [3,3])
C0010200 (UMLS CUI [4,1])
C0332281 (UMLS CUI [4,2])
C0015967 (UMLS CUI [4,3])
C0003232 (UMLS CUI [5])
C0015967 (UMLS CUI [6])
Congestive heart failure New York Heart Association Classification
Item
6. patients with nyha class 3 or 4 congestive heart failure.
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
HIV Infection | Hepatitis B | Hepatitis C
Item
7. patients with known hiv or hepatitis b or c
boolean
C0019693 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
Pregnancy | Breast Feeding | Patients Contraceptive methods Absent
Item
8. patients who are pregnant or lactating or not practicing adequate contraception
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0030705 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Medical condition Interferes with Informed Consent | Medical condition Interferes with Compliance behavior | Medical condition Interferes with Study Subject Participation Status | Medical condition Interferes with Interpretation Research results | Mental disorder Interferes with Informed Consent | Mental disorder Interferes with Compliance behavior | Mental disorder Interferes with Study Subject Participation Status | Mental disorder Interferes with Interpretation Research results | Substance Use Disorder Interferes with Informed Consent | Substance Use Disorder Interferes with Compliance behavior | Substance Use Disorder Interferes with Study Subject Participation Status | Substance Use Disorder Interferes with Interpretation Research results
Item
9. patients with any other medical condition, including mental illness or substance abuse, deemed by the investigator to be likely to interfere with the patient's ability to sign the icf or his/her ability to cooperate and participate in the study, or to interfere with the interpretation of the results.
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C1321605 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
C3843040 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0459471 (UMLS CUI [4,3])
C0683954 (UMLS CUI [4,4])
C0004936 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C0021430 (UMLS CUI [5,3])
C0004936 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C1321605 (UMLS CUI [6,3])
C0004936 (UMLS CUI [7,1])
C0521102 (UMLS CUI [7,2])
C2348568 (UMLS CUI [7,3])
C0004936 (UMLS CUI [8,1])
C0521102 (UMLS CUI [8,2])
C0459471 (UMLS CUI [8,3])
C0683954 (UMLS CUI [8,4])
C0038586 (UMLS CUI [9,1])
C0521102 (UMLS CUI [9,2])
C0021430 (UMLS CUI [9,3])
C0038586 (UMLS CUI [10,1])
C0521102 (UMLS CUI [10,2])
C1321605 (UMLS CUI [10,3])
C0038586 (UMLS CUI [11,1])
C0521102 (UMLS CUI [11,2])
C2348568 (UMLS CUI [11,3])
C0038586 (UMLS CUI [12,1])
C0521102 (UMLS CUI [12,2])
C0459471 (UMLS CUI [12,3])
C0683954 (UMLS CUI [12,4])
Systemic therapy Breast Carcinoma
Item
10. patients who are receiving concomitant systemic therapy for breast cancer.
boolean
C1515119 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
Leptomeningeal disease
Item
11. patients with leptomeningeal disease (lmd) or with a history of lmd will be excluded.
boolean
C0751297 (UMLS CUI [1])