Gender | Age
Item
women aged ≥ 18 years and < 70 years
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Karnofsky Performance Status
Item
karnofsky performance status (kps) ≥ 70
boolean
C0206065 (UMLS CUI [1])
Measurable Disease Quantity | Invasive carcinoma of breast | Exception Inflammatory Breast Carcinoma | Breast Carcinoma TNM Breast tumor staging | Locally advanced breast cancer TNM Breast tumor staging
Item
at least one measurable disease according to the recist. histologically confirmed invasive breast cancer (excluding inflammatory breast cancer), t2n1 or locally advanced breast cancer (t3-4n0-3 or t0-4n2-3)
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0853879 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0278601 (UMLS CUI [3,2])
C0678222 (UMLS CUI [4,1])
C0474926 (UMLS CUI [4,2])
C3495949 (UMLS CUI [5,1])
C0474926 (UMLS CUI [5,2])
Biopsy sample Estrogen Receptor Detection | Biopsy sample Progesterone Receptor Detection | Biopsy sample HER2 Detection | Triple Negative Breast Neoplasms | HER2-positive carcinoma of breast | HER2 Positive FISH | HER2 Positive CISH | HER2 Positive Immunohistochemistry
Item
biopsy specimens are available for er, pgr and her2 detection, patients should be with triple negative or her2 positive breast cancer, her2 positivity is defined as fish/cish her2 positive or ihc her2 3+, triple-negative disease defined as negativity for er, pgr and her2
boolean
C0677862 (UMLS CUI [1,1])
C0034804 (UMLS CUI [1,2])
C1511790 (UMLS CUI [1,3])
C0677862 (UMLS CUI [2,1])
C0034833 (UMLS CUI [2,2])
C1511790 (UMLS CUI [2,3])
C0677862 (UMLS CUI [3,1])
C0242957 (UMLS CUI [3,2])
C1511790 (UMLS CUI [3,3])
C3539878 (UMLS CUI [4])
C1960398 (UMLS CUI [5])
C2348909 (UMLS CUI [6,1])
C0162789 (UMLS CUI [6,2])
C2348909 (UMLS CUI [7,1])
C1516514 (UMLS CUI [7,2])
C2348909 (UMLS CUI [8,1])
C0021044 (UMLS CUI [8,2])
Bone Marrow function | Neutrophil count | Hemoglobin measurement | Platelet Count measurement
Item
adequate bone marrow function: neutrophil ≥ 1.5*109/l; hb ≥ 100g/l; plt ≥ 100*109/l
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0200633 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
Life Expectancy
Item
an estimated life expectancy of at least 12 months
boolean
C0023671 (UMLS CUI [1])
Biopsy | Neoadjuvant Chemotherapy | Patients Available Treatment | Patients Available Follow-up
Item
willing to take biopsy before neoadjuvant chemotherapy and patients must be accessible for treatment and follow-up
boolean
C0005558 (UMLS CUI [1])
C0600558 (UMLS CUI [2,1])
C3665472 (UMLS CUI [2,2])
C0030705 (UMLS CUI [3,1])
C0470187 (UMLS CUI [3,2])
C0087111 (UMLS CUI [3,3])
C0030705 (UMLS CUI [4,1])
C0470187 (UMLS CUI [4,2])
C3274571 (UMLS CUI [4,3])
Childbearing Potential Urine pregnancy test negative | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Contraceptive methods
Item
women with potential child-bearing must have a negative pregnancy test (urine or serum) within 7 days of drug administration and agree to use an acceptable method of birth control to avoid pregnancy for the duration of the study
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])
Informed Consent
Item
written informed consent according to the gcp
boolean
C0021430 (UMLS CUI [1])
Systemic therapy Breast Carcinoma | Therapy Local-Regional Breast Carcinoma | Chemotherapy Breast Carcinoma
Item
prior systemic or loco-regional treatment of breast cancer, including chemotherapy
boolean
C1515119 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1947913 (UMLS CUI [2,2])
C0678222 (UMLS CUI [2,3])
C0392920 (UMLS CUI [3,1])
C0678222 (UMLS CUI [3,2])
Secondary malignant neoplasm of female breast
Item
metastatic breast cancer
boolean
C0346993 (UMLS CUI [1])
Malignant Neoplasms | Exception Carcinoma in situ of uterine cervix | Exception Basal cell carcinoma
Item
with a history of malignant tumor except uterine cervix cancer in situ or skin basal cell carcinoma
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
Medical condition intolerant Neoadjuvant Therapy | Medical condition intolerant Therapeutic procedure Similar | Lung disease Uncontrolled | Diabetes Mellitus | Communicable Disease Severe | Peptic Ulcer | Blood Coagulation Disorder | Connective Tissue Disease | Myelosuppression adult
Item
patients with medical conditions that indicate intolerant to neoadjuvant therapy and related treatment, including uncontrolled pulmonary disease, diabetes mellitis, severe infection, active peptic ulcer, coagulation disorder, connective tissue disease or myelo-suppressive disease
boolean
C3843040 (UMLS CUI [1,1])
C0231200 (UMLS CUI [1,2])
C0600558 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0231200 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C2348205 (UMLS CUI [2,4])
C0024115 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0011849 (UMLS CUI [4])
C0009450 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C0030920 (UMLS CUI [6])
C0005779 (UMLS CUI [7])
C0009782 (UMLS CUI [8])
C0549484 (UMLS CUI [9])
Liver function Inadequate | Elevated total bilirubin | Alanine aminotransferase increased | Aspartate aminotransferase increased | Alkaline phosphatase raised | Renal function Inadequate | Serum creatinine raised | Creatinine clearance measurement
Item
inadequate liver function (bilirubin > 1.0 times upper normal limit [unl] and alt and/or ast> 1.5 unl associated with alkaline phosphatase > 2.5 unl; inadequate renal function (creatinine > 1.0 times unl and in case of limit value, creatinine clearance < 60 ml/min)
boolean
C0232741 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
C0741494 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
C0151904 (UMLS CUI [4])
C0151849 (UMLS CUI [5])
C0232804 (UMLS CUI [6,1])
C0205412 (UMLS CUI [6,2])
C0700225 (UMLS CUI [7])
C0373595 (UMLS CUI [8])
Medical contraindication Dexamethasone
Item
contraindication for using dexamethasone
boolean
C1301624 (UMLS CUI [1,1])
C0011777 (UMLS CUI [1,2])
Congestive heart failure | Angina Pectoris Uncontrolled | Angina Pectoris Symptomatic | Cardiac Arrhythmia | Myocardial Infarction | Poor hypertension control | Systolic Pressure | Diastolic blood pressure
Item
history of congestive heart failure, uncontrolled or symptomatic angina pectoris, arrhythmia or myocardial infarction; poorly controlled hypertension (systolic bp > 180 mmhg or diastolic bp > 100 mmhg)
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])
C0421190 (UMLS CUI [6])
C0871470 (UMLS CUI [7])
C0428883 (UMLS CUI [8])
Peripheral Neuropathy CTCAE Grades
Item
has peripheral neuropathy ≥ grade 1
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
patient is pregnant or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Severe allergy Investigational New Drugs
Item
known severe hypersensitivity to any drugs in this study
boolean
C2945656 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Investigational New Drugs
Item
treatment with any investigational drugs within 30 days before the beginning of study treatment
boolean
C0013230 (UMLS CUI [1])