Gender | Invasive carcinoma of breast Firstly | Prior Therapy Absent Invasive cancer
Item
1. female patients, presenting for the first time with invasive breast cancer, who have not received any previous treatment for an invasive malignancy
boolean
C0079399 (UMLS CUI [1])
C0853879 (UMLS CUI [2,1])
C1279901 (UMLS CUI [2,2])
C1514463 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0677898 (UMLS CUI [3,3])
Age | Life Expectancy
Item
2. aged ≥18 years and < 70 years with life expectancy > 12 months
boolean
C0001779 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
Invasive carcinoma of breast TNM Breast tumor staging Core needle biopsy | Exception Inflammatory Breast Carcinoma | Neoplasm Metastasis Absent | Tumor size
Item
3. histologically confirmed invasive breast cancer (excluding inflammatory breast cancer) by core needle biopsy, staged ii-iii according to tnm classification system, with no evidence of metastasis and tumor size ≥3 cm
boolean
C0853879 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
C1318309 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0278601 (UMLS CUI [2,2])
C0027627 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0475440 (UMLS CUI [4])
HER2 Positive Immunohistochemistry | FISH Positive
Item
4. her2 positive confirmed by ihc 2+ and fish positivity or ihc 3+
boolean
C2348909 (UMLS CUI [1,1])
C0021044 (UMLS CUI [1,2])
C0162789 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
Measurable lesion Quantity
Item
5. at least one measurable lesion according to recist criteria 1.1
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Left ventricular ejection fraction MUGA scan | Left ventricular ejection fraction Echocardiography
Item
6. patients with a left ventricular ejection fraction(lvef)≥55% by muga scan or echocardiography
boolean
C0428772 (UMLS CUI [1,1])
C0521317 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2,1])
C0013516 (UMLS CUI [2,2])
ECOG performance status
Item
7. ecog ps 0-1
boolean
C1520224 (UMLS CUI [1])
Biopsy Before Operative Surgical Procedures | Biopsy During Chemotherapy | Chemotherapy Preoperative
Item
8. willing to take biopsy before surgery and during chemotherapy and willing to take pre-operative chemotherapy and related treatment
boolean
C0005558 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
C0005558 (UMLS CUI [2,1])
C0347984 (UMLS CUI [2,2])
C0392920 (UMLS CUI [2,3])
C0392920 (UMLS CUI [3,1])
C0445204 (UMLS CUI [3,2])
Informed Consent | Protocol Compliance
Item
9. signed written informed consent; able to comply with the protocol
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
1. patient is pregnant or lactating.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential Urine pregnancy test negative | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Contraceptive methods
Item
2. women of child-bearing potential must have a negative pregnancy test (urine or serum) within 7 days of drug administration and agree to take an adequate contraceptive measure
boolean
C3831118 (UMLS CUI [1,1])
C0430057 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430061 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Prior Chemotherapy | Prior Hormone Therapy | Cancer treatment Against HER2
Item
3. previous treatment with chemotherapy or hormonal therapy or any prior therapy with an anti-her2 therapy for any malignancy.
boolean
C1514457 (UMLS CUI [1])
C1514460 (UMLS CUI [2])
C0920425 (UMLS CUI [3,1])
C0521124 (UMLS CUI [3,2])
C0069515 (UMLS CUI [3,3])
Congestive heart failure | Angina Pectoris Uncontrolled | Angina Pectoris Symptomatic | Cardiac Arrhythmia | Myocardial Infarction
Item
4. history of congestive heart failure, uncontrolled or symptomatic angina pectoris, arrhythmia or myocardial infarction
boolean
C0018802 (UMLS CUI [1])
C0002962 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0002962 (UMLS CUI [3,1])
C0231220 (UMLS CUI [3,2])
C0003811 (UMLS CUI [4])
C0027051 (UMLS CUI [5])
Invasive cancer Affecting Protocol Compliance | Invasive cancer Affecting Interpretation Research results | Including Breast Carcinoma primary second | Exception Curative treatment Malignant disease | Exception Malignant disease Free Duration
Item
5. other invasive malignancy (including second primary breast cancer) which could affect compliance with the protocol or interpretation of results. patients who have been curatively treated and free of malignant disease for greater than 5 years are generally eligible
boolean
C0677898 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0677898 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0459471 (UMLS CUI [2,3])
C0683954 (UMLS CUI [2,4])
C0332257 (UMLS CUI [3,1])
C0678222 (UMLS CUI [3,2])
C0205225 (UMLS CUI [3,3])
C0205436 (UMLS CUI [3,4])
C1705847 (UMLS CUI [4,1])
C1273390 (UMLS CUI [4,2])
C0442867 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0442867 (UMLS CUI [5,2])
C0332296 (UMLS CUI [5,3])
C0449238 (UMLS CUI [5,4])
Bone Marrow function Inadequate | Liver function Inadequate | Renal function Inadequate
Item
6. inadequate bone marrow, hepatic and renal functions as evidenced by the following:
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0205412 (UMLS CUI [1,3])
C0232741 (UMLS CUI [2,1])
C0205412 (UMLS CUI [2,2])
C0232804 (UMLS CUI [3,1])
C0205412 (UMLS CUI [3,2])
Neutrophil count
Item
neutrophil count of <1500/ul,
boolean
C0200633 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count of <100,000/ul.
boolean
C0032181 (UMLS CUI [1])
Hemoglobin measurement
Item
haemoglobin <10 g/dl.
boolean
C0518015 (UMLS CUI [1])
SERUM TOTAL BILIRUBIN ELEVATED
Item
serum total bilirubin > 1.5*uln (upper limit of normal),
boolean
C0595866 (UMLS CUI [1])
Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
alt or ast > 2.5*uln,
boolean
C0151905 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
Alkaline phosphatase raised
Item
alkaline phosphatase > 2.5*uln,
boolean
C0151849 (UMLS CUI [1])
Serum creatinine raised
Item
serum creatinine > 1.5*uln.
boolean
C0700225 (UMLS CUI [1])
Illness Serious | Other medical condition Serious
Item
7. other serious illness or medical condition including:
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C3843040 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
Congestive heart failure New York Heart Association Classification | Medical History Congestive heart failure | Angina, Unstable | Myocardial Infarction | Heart valve disease | High risk Cardiac Arrhythmia Uncontrolled
Item
congestive heart failure (nyha class ii, iii, iv) or history of documented congestive heart failure, unstable angina pectoris, myocardial infarction in the last 6 months, clinically significant valvular heart disease, or high-risk uncontrolled arrhythmias.
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0018802 (UMLS CUI [2,2])
C0002965 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
C0018824 (UMLS CUI [5])
C4319571 (UMLS CUI [6,1])
C0003811 (UMLS CUI [6,2])
C0205318 (UMLS CUI [6,3])
Resting Dyspnea Due to Malignant disease | Resting Dyspnea Due to Disease | Secondary malignant neoplasm of lung with Lymphangitis | Patient need for Oxygen therapy support
Item
patients with dyspnoea at rest due to malignant or other disease (e.g. pulmonary metastases with lymphangitis) or who require supportive oxygen therapy.
boolean
C0743330 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0442867 (UMLS CUI [1,3])
C0743330 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0012634 (UMLS CUI [2,3])
C0153676 (UMLS CUI [3,1])
C0332287 (UMLS CUI [3,2])
C0024225 (UMLS CUI [3,3])
C0686904 (UMLS CUI [4,1])
C3872899 (UMLS CUI [4,2])
Communicable Diseases Serious Uncontrolled
Item
active serious uncontrolled infections.
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
Poorly controlled diabetes mellitus
Item
poorly controlled diabetes mellitus.
boolean
C0554876 (UMLS CUI [1])
Biopsy Preoperative Unwilling | Neoadjuvant Therapy Unwilling
Item
8. not willing to take pre-operative biopsy or neo-adjuvant therapy
boolean
C0005558 (UMLS CUI [1,1])
C0445204 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C0600558 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Mental disorders Treatment Compliance Lacking | Other medical condition Treatment Compliance Lacking
Item
9. patients with psychiatric disorder or other disease leading to incompliance to the therapy
boolean
C0004936 (UMLS CUI [1,1])
C4319828 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C4319828 (UMLS CUI [2,2])
C0332268 (UMLS CUI [2,3])
Hypersensitivity Investigational Therapy Ingredient
Item
10. known hypersensitivity to any ingredient of the regimen
boolean
C0020517 (UMLS CUI [1,1])
C0949266 (UMLS CUI [1,2])
C1550600 (UMLS CUI [1,3])
Investigational New Drugs Recent
Item
11. treatment with any investigational drug within 30 days before the beginning of treatment with study drug.
boolean
C0013230 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])