Breast Carcinoma | Invasive carcinoma of breast Operable TNM Breast tumor staging | Invasive carcinoma of breast Advanced Locally TNM Breast tumor staging | Invasive carcinoma of breast inflammatory TNM Breast tumor staging | Breast Carcinoma Appropriate Neoadjuvant Chemotherapy
Item
1. newly diagnosed histologically confirmed bc with breast infiltrating carcinoma of histological grade > 1 (either operable, or locally advanced or inflammatory) candidate for neoadjuvant chemotherapy
boolean
C0678222 (UMLS CUI [1])
C0853879 (UMLS CUI [2,1])
C0205188 (UMLS CUI [2,2])
C0474926 (UMLS CUI [2,3])
C0853879 (UMLS CUI [3,1])
C0205179 (UMLS CUI [3,2])
C1517927 (UMLS CUI [3,3])
C0474926 (UMLS CUI [3,4])
C0853879 (UMLS CUI [4,1])
C0333348 (UMLS CUI [4,2])
C0474926 (UMLS CUI [4,3])
C0678222 (UMLS CUI [5,1])
C1548787 (UMLS CUI [5,2])
C0600558 (UMLS CUI [5,3])
C3665472 (UMLS CUI [5,4])
Tumor HER2 Negative Immunohistochemistry | Tumor HER2 Negative FISH
Item
2. her2-negative tumor, defined according to immunohistochemistry or using fluorescent in-situ hybridization (fish)
boolean
C0027651 (UMLS CUI [1,1])
C2348908 (UMLS CUI [1,2])
C0021044 (UMLS CUI [1,3])
C0027651 (UMLS CUI [2,1])
C2348908 (UMLS CUI [2,2])
C0162789 (UMLS CUI [2,3])
ECOG performance status
Item
3. ecog performance status 0 or 1
boolean
C1520224 (UMLS CUI [1])
Gender
Item
4. gender: female
boolean
C0079399 (UMLS CUI [1])
Age
Item
5. age : >= 18 years old
boolean
C0001779 (UMLS CUI [1])
Childbearing Potential Pregnancy test negative
Item
6. negative pregnancy test (females of childbearing potential)
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Childbearing Potential Barrier Contraception Double
Item
7. willingness to perform double-barrier-contraception during study and for 6 months post chemotherapy treatment (females of childbearing potential)
boolean
C3831118 (UMLS CUI [1,1])
C0004764 (UMLS CUI [1,2])
C0205173 (UMLS CUI [1,3])
Informed Consent
Item
8. signed informed consent
boolean
C0021430 (UMLS CUI [1])
Neoplasm Metastasis | Recurrent disease
Item
1. metastatic or relapsed disease
boolean
C0027627 (UMLS CUI [1])
C0277556 (UMLS CUI [2])
Major surgery
Item
2. major surgery < 3 weeks prior to enrollment
boolean
C0679637 (UMLS CUI [1])
Obstructive Lung Diseases Severe | Restrictive pulmonary disease Severe
Item
3. severe pulmonary obstructive or restrictive disease
boolean
C0600260 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0877013 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Inflammatory disorder Uncontrolled | Autoimmune Disease Uncontrolled | Communicable Disease Uncontrolled
Item
4. uncontrolled inflammatory disease (autoimmune or infectious)
boolean
C1290884 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0004364 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0009450 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
Heart Disease New York Heart Association Classification
Item
5. clinically significant cardiac disease (nyha stadium > 2)
boolean
C0018799 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Laboratory test result abnormal | Hematology procedure | Chemistry procedure
Item
6. results of laboratory tests (hematology, chemistry) outside specified limits:
boolean
C0438215 (UMLS CUI [1])
C0200627 (UMLS CUI [2])
C0201682 (UMLS CUI [3])
White Blood Cell Count procedure
Item
wbc ≤ 3 x 109/l
boolean
C0023508 (UMLS CUI [1])
Absolute neutrophil count
Item
anc < 1.5 x 109/l
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelets < 100 x 109/l
boolean
C0032181 (UMLS CUI [1])
Hemoglobin measurement
Item
hb ≤ 9.0 g/dl (≤ 5.6 mmol/l)
boolean
C0518015 (UMLS CUI [1])
Partial thromboplastin time increased | INR raised
Item
ptt/ inr > 1.5 x uln
boolean
C0240671 (UMLS CUI [1])
C0853225 (UMLS CUI [2])
Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
ast or alt > 2.5 x uln
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
Serum alkaline phosphatase raised
Item
alkaline phosphatase > 2 x uln
boolean
C1314665 (UMLS CUI [1])
Elevated total bilirubin
Item
total bilirubin > 1.5 x uln
boolean
C0741494 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
7. pregnancy or nursing status
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
HIV Seropositivity
Item
8. known positive hiv testing
boolean
C0019699 (UMLS CUI [1])
Hypersensitivity EndoTAG-1 Component | Hypersensitivity Paclitaxel Component | Hypersensitivity FEC Component
Item
9. known hypersensitivity to any component of the endotag-1, paclitaxel or fec formulations
boolean
C0020517 (UMLS CUI [1,1])
C2347570 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0144576 (UMLS CUI [2,2])
C1705248 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0060133 (UMLS CUI [3,2])
C1705248 (UMLS CUI [3,3])
Malignant Neoplasms | Exception Breast Carcinoma | Exception Local Therapy Skin carcinoma | Exception Local Therapy Basal cell carcinoma | Exception Local Therapy Squamous cell carcinoma of skin
Item
10. history of malignancy other than breast cancer < 5 years prior to enrollment, except skin cancer (i.e. basal or squamous cell carcinoma) treated locally
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1517925 (UMLS CUI [3,2])
C0699893 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1517925 (UMLS CUI [4,2])
C0007117 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C1517925 (UMLS CUI [5,2])
C0553723 (UMLS CUI [5,3])
Nervous system disorder Preventing Informed Consent | Mental disorder Preventing Informed Consent | Nervous system disorder Interferes with Evaluation Central Nervous System | Mental disorder Interferes with Evaluation Central Nervous System
Item
11. history of active or significant neurological disorder or psychiatric disorder that would prohibit the understanding and giving of informed consent, or would interfere in the clinical and radiological evaluation of central nervous system during the trial
boolean
C0027765 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C0004936 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
C0027765 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C1261322 (UMLS CUI [3,3])
C3714787 (UMLS CUI [3,4])
C0004936 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C1261322 (UMLS CUI [4,3])
C3714787 (UMLS CUI [4,4])
Study Subject Participation Status | Investigational New Drugs
Item
12. concurrent treatment with other experimental products. participation in another clinical trial with any investigational product within 30 days prior to study entry
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])