Age | Breast Carcinoma | Exception Neoplasm Metastasis | Tumor size Minimum | Lesion TNM clinical staging | Neoadjuvant Chemotherapy Recommended
Item
patients ≥ 18 years of age with histologically, and radiographically confirmed non-metastatic breast cancer with minimal tumor size over 1 cm (≥t1c lesion) to receive neoadjuvant chemotherapy recommended by the treating physician
boolean
C0001779 (UMLS CUI [1])
C0678222 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0027627 (UMLS CUI [3,2])
C0475440 (UMLS CUI [4,1])
C1524031 (UMLS CUI [4,2])
C0221198 (UMLS CUI [5,1])
C3258246 (UMLS CUI [5,2])
C0600558 (UMLS CUI [6,1])
C3665472 (UMLS CUI [6,2])
C0034866 (UMLS CUI [6,3])
Oestrogen receptor positive breast cancer | Human epidermal growth factor 2 negative carcinoma of breast
Item
for estrogen receptor (er) strongly positive, human epithelial receptor (her2) negative breast cancer, oncotype dx study is required. patients with low recurrence score will be excluded in the study.
boolean
C2938924 (UMLS CUI [1])
C2316304 (UMLS CUI [2])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status score < 1
boolean
C1520224 (UMLS CUI [1])
Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement
Item
absolute neutrophil count > 1500 mm3, platelet count ≥ 100×109 l, hemoglobin ≥ 8.5 g/dl
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
Serum creatinine raised | Serum total bilirubin measurement
Item
serum creatinine ≤1.5 times the upper limit of the normal range, total bilirubin ≤
boolean
C0700225 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
Gilbert Disease | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
1.5 x uln (≤ 3 mg/dl if clinically diagnosed with gilbert syndrome) ast/alt ≤ 2.5 x uln (ast/alt ≤ 5x uln if clinically diagnosed with gilbert syndrome)
boolean
C0017551 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
Collection of blood specimen for laboratory procedure Correlative Study
Item
willing to provide blood samples for correlative research purposes
boolean
C0005834 (UMLS CUI [1,1])
C1511524 (UMLS CUI [1,2])
Childbearing Potential Contraceptive methods | Premenopausal state | Female Sterilization Absent | Sexual Abstinence | Contraceptives, Oral | Barrier Contraception Double | Childbearing Potential Urine pregnancy test negative | Childbearing Potential Serum pregnancy test negative
Item
women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must be willing to use an acceptable contraceptive method (abstinence, oral contraceptive or double barrier method) for the duration of the study and for 30 days following the last dose of study drug, and must have a negative urine or serum pregnancy test within 2 weeks prior to beginning treatment on this trial.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0232969 (UMLS CUI [2])
C0015787 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0036899 (UMLS CUI [4])
C0009905 (UMLS CUI [5])
C0004764 (UMLS CUI [6,1])
C0205173 (UMLS CUI [6,2])
C3831118 (UMLS CUI [7,1])
C0430057 (UMLS CUI [7,2])
C3831118 (UMLS CUI [8,1])
C0430061 (UMLS CUI [8,2])
Heart Disease Uncontrolled | Angina Pectoris | Hypertensive disease | Cardiac Arrhythmia | Congestive heart failure New York Heart Association Classification | Left ventricular ejection fraction
Item
1. uncontrolled cardiac disease, such as angina, hypertension or significant arrhythmias, congestive heart failure (nyha grade 2 or more or lvef < 40% on any prior assessment). note: assessment of lvef is done before and after anthracycline-based or trastuzumab-based chemotherapy as standard of care
boolean
C0018799 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0002962 (UMLS CUI [2])
C0020538 (UMLS CUI [3])
C0003811 (UMLS CUI [4])
C0018802 (UMLS CUI [5,1])
C1275491 (UMLS CUI [5,2])
C0428772 (UMLS CUI [6])
Pregnancy | Breast Feeding
Item
2. pregnant or lactating females
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Diabetes Mellitus | Glucose measurement, fasting | Hemoglobin A1c measurement
Item
3. known history of diabetes mellitus. if screening fasting glucose is ≥126 mg/dl, an hba1c must be < 6.5%.
boolean
C0011849 (UMLS CUI [1])
C0202045 (UMLS CUI [2])
C0474680 (UMLS CUI [3])
Syncope | Low-Calorie Diet
Item
4. history of syncope with calorie restriction in the past
boolean
C0039070 (UMLS CUI [1])
C2930544 (UMLS CUI [2])
Body mass index
Item
5. body mass index (bmi) < 19 kg/m2
boolean
C1305855 (UMLS CUI [1])
Sign or Symptom Gastrointestinal obstruction | Requirement Parenteral fluids for hydration | Requirement Parenteral Nutrition
Item
6. clinical signs or symptoms of gi obstruction and/or requirement for parenteral hydration or nutrition
boolean
C3540840 (UMLS CUI [1,1])
C0236124 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C2034480 (UMLS CUI [3])
C0030547 (UMLS CUI [4])
Informed Consent Unable | Protocol Compliance Unable
Item
7. inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Comorbidity Severe | Communicable Disease | Mental disorder Limiting Safety | Social situation Limiting Safety | Mental disorder Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
Item
8. concurrent severe illness such as active infection, or psychiatric illness/social situations that would limit safety and compliance with study requirements
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0004936 (UMLS CUI [3,1])
C0439801 (UMLS CUI [3,2])
C0036043 (UMLS CUI [3,3])
C0748872 (UMLS CUI [4,1])
C0439801 (UMLS CUI [4,2])
C0036043 (UMLS CUI [4,3])
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])
Comorbidity Requirement Pharmaceutical Preparations Daily
Item
9. any other medical comorbidity that requires daily medication(s) that may not be safely taken without food.
boolean
C0009488 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0332173 (UMLS CUI [1,4])