Secondary malignant neoplasm of female breast HER2 Negative | Dose Escalation | Maximum Tolerated Dose | Advanced solid tumor
Item
1. biopsy proven her2 negative metastatic breast cancer (dose escalation portion and mtd expansion portion) or advanced solid tumor (dose escalation portion).
boolean
C0346993 (UMLS CUI [1,1])
C2348908 (UMLS CUI [1,2])
C3816728 (UMLS CUI [2])
C0752079 (UMLS CUI [3])
C4329281 (UMLS CUI [4])
ASS deficiency | Tissue specimen Immunohistochemistry
Item
2. ass deficiency (defined as <50% ass expression) demonstrated on tissue specimen by immunohistochemistry (ihc). cytology and fine need aspirate specimens are not acceptable for ass testing.
boolean
C0175683 (UMLS CUI [1])
C1292533 (UMLS CUI [2,1])
C0021044 (UMLS CUI [2,2])
Disease unresectable | Study Subject Refused Surgery
Item
3. unresectable disease or subject refused surgery.
boolean
C0012634 (UMLS CUI [1,1])
C1519810 (UMLS CUI [1,2])
C0681850 (UMLS CUI [2,1])
C0749192 (UMLS CUI [2,2])
Measurable Disease
Item
4. measurable disease as assessed by recist 1.1 criteria (appendix a).
boolean
C1513041 (UMLS CUI [1])
Therapy Available failed | Chemotherapy Quantity Neoplasm Metastasis
Item
5. failed available therapy known to confer clinical benefit but no more than 4 prior lines of chemotherapy for metastatic disease.
boolean
C0087111 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
C0392920 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0027627 (UMLS CUI [2,3])
Treatment failure | Therapy Containing Doxorubicin
Item
6. time to treatment failure from doxorubicin containing regimen ≥ 12 months if previously treated with doxorubicin.
boolean
C0162643 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0332256 (UMLS CUI [2,2])
C0013089 (UMLS CUI [2,3])
Age
Item
7. age ≥ 18 years.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
8. ecog performance status of 0 - 2. -
boolean
C1520224 (UMLS CUI [1])
Communicable Disease Serious | Requirement Antibiotics for systemic use
Item
1. serious infection requiring treatment with systemically administered antibiotics at the time of study entrance, or an infection requiring systemic antibiotic therapy within 7 days prior to the first dose of study treatment.
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C3540704 (UMLS CUI [2,2])
Exposure to Epirubicin Dosage
Item
2. prior epirubicin exposure of > 600 mg/m2.
boolean
C0332157 (UMLS CUI [1,1])
C0014582 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
Pregnancy | Breast Feeding
Item
3. pregnancy or lactation.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Compliance behavior Unlikely
Item
4. expected non-compliance.
boolean
C1321605 (UMLS CUI [1,1])
C0750558 (UMLS CUI [1,2])
Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure New York Heart Association Classification | Cardiac Arrhythmia | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
Item
5. uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (new york heart association class iii or iv), 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 [3,1])
C1275491 (UMLS CUI [3,2])
C0003811 (UMLS CUI [4])
C0004936 (UMLS CUI [5,1])
C0439801 (UMLS CUI [5,2])
C0525058 (UMLS CUI [5,3])
C0748872 (UMLS CUI [6,1])
C0439801 (UMLS CUI [6,2])
C0525058 (UMLS CUI [6,3])
Cancer treatment | Recovery Lacking | Exception Alopecia | Absence Recovery CTCAE Grades | Irreversible toxic effect Cancer treatment
Item
6. subjects who have had any anticancer treatment prior to entering the study and have not recovered to baseline (except alopecia) or ≤ grade 1 aes, or deemed irreversible from the effects of prior cancer therapy. aes > grade 1 that are not considered a safety risk by the sponsor and investigator may be allowed upon agreement with both.
boolean
C0920425 (UMLS CUI [1])
C2004454 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0002170 (UMLS CUI [3,2])
C0332197 (UMLS CUI [4,1])
C2004454 (UMLS CUI [4,2])
C1516728 (UMLS CUI [4,3])
C0678774 (UMLS CUI [5,1])
C0920425 (UMLS CUI [5,2])
Cancer Other Primary | Second Cancer | Exception Skin carcinoma Resected Curative | Exception Curative treatment Carcinoma in situ of uterine cervix | Exception Solid tumor Disease Free of
Item
7. subjects with history of another primary cancer, including co-existent second malignancy, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present in the opinion of the investigator will not affect subject outcome in the setting of breast cancer diagnosis.
boolean
C1707251 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0751623 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0699893 (UMLS CUI [3,2])
C1521996 (UMLS CUI [3,3])
C1276305 (UMLS CUI [3,4])
C1705847 (UMLS CUI [4,1])
C1273390 (UMLS CUI [4,2])
C0851140 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0280100 (UMLS CUI [5,2])
C0012634 (UMLS CUI [5,3])
C0332296 (UMLS CUI [5,4])
ADI PEG20
Item
8. subjects who had been treated with adi-peg 20 previously.
boolean
C1328192 (UMLS CUI [1])