Gender | Age
Item
1. female patients, age ≥20 years
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Breast adenocarcinoma Triple Negative
Item
2. histologically confirmed invasive er-, pr-, and her2-negative (triple-negative) adenocarcinoma of the breast
boolean
C0858252 (UMLS CUI [1,1])
C3539878 (UMLS CUI [1,2])
Triple Negative Breast Neoplasms
Item
3. triple-negative tumors are defined as:
boolean
C3539878 (UMLS CUI [1])
HER2/Neu Negative | FISH Negative | Immunohistochemistry | Estrogen receptor negative | Progesterone receptor negative | Neoplasm Staining Percentage Immunohistochemistry
Item
i. for her2-negative: fluorescence in situ hybridization (fish)-negative (defined by ratio <2.0) or immunohistochemical (ihc) 0, ihc 1+, or ihc 2+ or ihc 3+and fish-negative (defined by ratio <2.0) ii. for er- and pr-negative: < 5% tumor staining by immunohistochemistry (ihc)
boolean
C2348908 (UMLS CUI [1])
C0162789 (UMLS CUI [2,1])
C1513916 (UMLS CUI [2,2])
C0021044 (UMLS CUI [3])
C0279756 (UMLS CUI [4])
C0279766 (UMLS CUI [5])
C0027651 (UMLS CUI [6,1])
C1704680 (UMLS CUI [6,2])
C0439165 (UMLS CUI [6,3])
C0021044 (UMLS CUI [6,4])
Triple Negative Breast Neoplasms | EGFR Gene Expression | EGFR Gene Expression Absent | EGFR gene mutation | EGFR gene mutation Absent | Analysis Frequency of Responses
Item
4. the first tnbc 20 patients with or without egfr expression or mutation are eligible. interim analysis of response rate will be calculated to determine the criteria of 21 to 40 patients.
boolean
C3539878 (UMLS CUI [1])
C0034802 (UMLS CUI [2,1])
C0017262 (UMLS CUI [2,2])
C0034802 (UMLS CUI [3,1])
C0017262 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C3266992 (UMLS CUI [4])
C3266992 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0936012 (UMLS CUI [6,1])
C0237629 (UMLS CUI [6,2])
Triple Negative Breast Neoplasms | Lymph node positive TNM Breast tumor staging | Negative Lymph Node TNM Breast tumor staging | Lesion TNM Breast tumor staging Excluded | Neoplasm Metastasis Excluded | Tumor size Physical Examination | Tumor size Image study
Item
5. all of the newly diagnosed tnbc patients should be met the following criteria: clinical node-positive with any t stage patents or clinical node-negative patients with ct2-4. ct1n0m0 lesions are excluded. patients with metastatic disease are excluded. the measurement method of tumor size can be by physical exam and/or image study.
boolean
C3539878 (UMLS CUI [1])
C0746319 (UMLS CUI [2,1])
C0474926 (UMLS CUI [2,2])
C0678034 (UMLS CUI [3,1])
C0474926 (UMLS CUI [3,2])
C0221198 (UMLS CUI [4,1])
C0474926 (UMLS CUI [4,2])
C0332196 (UMLS CUI [4,3])
C0027627 (UMLS CUI [5,1])
C0332196 (UMLS CUI [5,2])
C0475440 (UMLS CUI [6,1])
C0031809 (UMLS CUI [6,2])
C0475440 (UMLS CUI [7,1])
C1881134 (UMLS CUI [7,2])
ECOG performance status
Item
6. eastern cooperative oncology group performance status (ecog ps) 0-1.
boolean
C1520224 (UMLS CUI [1])
Status pre- Randomization
Item
7. within 2 weeks prior randomization:
boolean
C0332152 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
Bone Marrow function | Liver function | Renal function | Blood Pressure Controlled | Antihypertensive therapy | Antihypertensive therapy Absent | Prothrombin time normal | Partial prothrombin time Normal | Cardiac function 12 lead ECG | Cardiac function Echocardiography | Left ventricular ejection fraction
Item
i. adequate bone marrow function, hepatic function, and renal function. ii. controlled blood pressure with or without antihypertensive treatment iii. normal prothrombin time (pt) and partial thromboplastin time (ptt) iv. adequate cardiac function assessed by 12-lead ecg and if clinically indicated echocardiography to document lvef
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
C0005823 (UMLS CUI [4,1])
C2587213 (UMLS CUI [4,2])
C0585941 (UMLS CUI [5])
C0585941 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
C0580551 (UMLS CUI [7])
C0853653 (UMLS CUI [8,1])
C0205307 (UMLS CUI [8,2])
C0232164 (UMLS CUI [9,1])
C0430456 (UMLS CUI [9,2])
C0232164 (UMLS CUI [10,1])
C0013516 (UMLS CUI [10,2])
C0428772 (UMLS CUI [11])
Bilateral breast cancer Synchronous
Item
8. bilateral, synchronous breast cancer is allowed if one primary tumor meets the inclusion criteria.
boolean
C0281267 (UMLS CUI [1,1])
C0439580 (UMLS CUI [1,2])
Bone Marrow function | White Blood Cell Count procedure | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement
Item
9. adequate bone marrow function defined as wbc ≥3.5 x 109/l, anc ≥1.5 x 109/l, platelets ≥lln, and hemoglobin ≥10 g/dl.
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0023508 (UMLS CUI [2])
C0948762 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
C0518015 (UMLS CUI [5])
Liver function | Serum total bilirubin measurement | Transaminase Assay
Item
10. adequate liver function defined as total serum bilirubin ≤1.5x uln and serum transaminases ≤2.5x uln
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0919834 (UMLS CUI [3])
Renal function | Creatinine measurement, serum
Item
11. adequate renal function defined as creatinine ≤1.5x uln
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Informed Consent Willing | Protocol Compliance Willing
Item
12. able and willing to give informed consent and comply with the protocol
boolean
C0021430 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C0600109 (UMLS CUI [2,2])
Informed Consent
Item
13. written informed consent obtained prior to any screening/baseline procedures
boolean
C0021430 (UMLS CUI [1])
Knowledge Study Protocol | Protocol Compliance
Item
14. knowledge of the investigational nature of the study and ability to provide consent for study participation; and ability and willingness to comply with study visits, treatment, testing, and other study procedures
boolean
C0376554 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2])
Estrogen receptor positive | Progesterone receptor positive | HER2 Protein Overexpression
Item
1. er+ (>5%) or pr+ (>5%) or her-2 overexpression
boolean
C0279754 (UMLS CUI [1])
C0279759 (UMLS CUI [2])
C1515560 (UMLS CUI [3])
Second Primary Cancer | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix
Item
2. active second malignancy during the last five years except non melanomatous skin cancer or carcinoma in situ of the cervix.
boolean
C0751623 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
Prior Chemotherapy | Prior radiation therapy | Targeted Therapy | Afatinib | HER-2 inhibitors | EGFR inhibitors
Item
3. prior chemotherapy, radiotherapy or targeted therapy including afatinib or her-2 or egfr inhibitors.
boolean
C1514457 (UMLS CUI [1])
C0279134 (UMLS CUI [2])
C2985566 (UMLS CUI [3])
C2987648 (UMLS CUI [4])
C2916795 (UMLS CUI [5])
C1443775 (UMLS CUI [6])
Study Subject Participation Status
Item
4. participation in another interventional clinical trial in the preceding 30 days prior to trial.
boolean
C2348568 (UMLS CUI [1])
Comorbidity Severe compromises Study Subject Participation Status | Comorbidity Uncontrolled compromises Study Subject Participation Status | Communicable Disease Severe compromises Study Subject Participation Status | Communicable Disease Uncontrolled compromises Study Subject Participation Status
Item
5. patients with other concurrent severe and/or uncontrolled medical disease or infection which could compromise participation in the study
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2945640 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C0009488 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C2945640 (UMLS CUI [2,3])
C2348568 (UMLS CUI [2,4])
C0009450 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C2945640 (UMLS CUI [3,3])
C2348568 (UMLS CUI [3,4])
C0009450 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C2945640 (UMLS CUI [4,3])
C2348568 (UMLS CUI [4,4])
Allergic Reaction Taxane | Allergic Reaction Cremophor EL
Item
6. prior hypersensitivity reactions to a taxane or to cremophor® el (polyoxyethylated castor oil)
boolean
C1527304 (UMLS CUI [1,1])
C0215136 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C0056476 (UMLS CUI [2,2])
Pregnancy | Serum pregnancy test (B-HCG) Positive | Breast Feeding
Item
7. pregnant or breast feeding (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by positive β-hcg laboratory test (serum > 5 miu/ml)
boolean
C0032961 (UMLS CUI [1])
C0430060 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C0006147 (UMLS CUI [3])
Childbearing Potential | Exception Use of Contraceptive methods
Item
8. women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for at least 180 days after study treatment. highly effective contraception methods include:
boolean
C3831118 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1524063 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
Sexual Abstinence
Item
true abstinence in line with the preferred and usual lifestyle of the subject
boolean
C0036899 (UMLS CUI [1])
Female Sterilization | Partner had vasectomy
Item
female subject or male partner sterilization or
boolean
C0015787 (UMLS CUI [1])
C0420842 (UMLS CUI [2])
Contraceptive methods Combination
Item
combination of any two of the following (a+b or a+c, or b+c):
boolean
C0700589 (UMLS CUI [1,1])
C0205195 (UMLS CUI [1,2])
Hormonal contraception | Contraceptives, Oral, Hormonal | Contraceptive injection | Contraceptive implant
Item
1. use of oral, injected or implanted hormonal methods of contraception
boolean
C2985296 (UMLS CUI [1])
C0009907 (UMLS CUI [2])
C1656586 (UMLS CUI [3])
C1657106 (UMLS CUI [4])
Intrauterine Devices | Intrauterine System Contraceptive Devices
Item
2. placement of an intrauterine device (iud) or intrauterine system (ius)
boolean
C0021900 (UMLS CUI [1])
C4293370 (UMLS CUI [2,1])
C0009886 (UMLS CUI [2,2])
Contraception, Barrier | Male Condoms Partner
Item
3. barrier methods of contraception: condom for male partner or occlusive cap
boolean
C0004764 (UMLS CUI [1])
C0009653 (UMLS CUI [2,1])
C0682323 (UMLS CUI [2,2])
Vaginal contraceptive diaphragm | CERVICAL CAP FOR CONTRACEPTIVE USE | Spermicidal foam/jelly/cream/film/suppository
Item
4. (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository
boolean
C0042241 (UMLS CUI [1])
C0493327 (UMLS CUI [2])
C3843415 (UMLS CUI [3])
Mental condition Interferes with Protocol Compliance | Condition Familial Interferes with Protocol Compliance | Sociological Factor Interferes with Protocol Compliance | Geographic Factor Interferes with Protocol Compliance
Item
9. patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
boolean
C3840291 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0241888 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C0525058 (UMLS CUI [2,4])
C3850138 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
C0017444 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])