Age
Item
1. age 18-70 years.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
2. performance status ecog 0-2.
boolean
C1520224 (UMLS CUI [1])
Breast Carcinoma HER2 Negative TNM Breast tumor staging | Breast cancer recurrent HER2 Negative
Item
3. clinically and / or radiologically proven stage iv or recurrent her2 negative breast cancer.
boolean
C0678222 (UMLS CUI [1,1])
C2348908 (UMLS CUI [1,2])
C0474926 (UMLS CUI [1,3])
C0278493 (UMLS CUI [2,1])
C2348908 (UMLS CUI [2,2])
Tumor Lesion Quantity | Lesion suitable Biopsy | Therapeutic radiology procedure Absent Lesion
Item
4. at least one tumor lesion accessible for biopsy. this lesion may not have been treated previously with irradiation.
boolean
C0027651 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0221198 (UMLS CUI [2,1])
C3900053 (UMLS CUI [2,2])
C0005558 (UMLS CUI [2,3])
C1522449 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0221198 (UMLS CUI [3,3])
Measurable Disease | Site Quantity Measurable Linear
Item
5. clinically and/or radiographically documented measurable disease according to recist v1.1 criteria. at least one site of disease must be unidimensionally measurable as follows:
boolean
C1513041 (UMLS CUI [1])
C1515974 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1513040 (UMLS CUI [2,3])
C0205132 (UMLS CUI [2,4])
Site Length CT scan | Site Length Physical Examination | Site Length Chest X-ray
Item
1. ct-scan, physical exam ≥ 10 mm} chest x-ray ≥ 20 mm }see eisenhauer et al. for more details
boolean
C1515974 (UMLS CUI [1,1])
C1444754 (UMLS CUI [1,2])
C0040405 (UMLS CUI [1,3])
C1515974 (UMLS CUI [2,1])
C1444754 (UMLS CUI [2,2])
C0031809 (UMLS CUI [2,3])
C1515974 (UMLS CUI [3,1])
C1444754 (UMLS CUI [3,2])
C0039985 (UMLS CUI [3,3])
Site Length Lymph node Short axis
Item
2. lymph node short axis ≥ 15 mm }
boolean
C1515974 (UMLS CUI [1,1])
C1444754 (UMLS CUI [1,2])
C0024204 (UMLS CUI [1,3])
C0522488 (UMLS CUI [1,4])
Radiology studies
Item
3. all radiology studies must be performed within 28 days prior to registration (35 days if negative).
boolean
C0807679 (UMLS CUI [1])
Bone Marrow function | Liver function | Renal function | Laboratory Procedures
Item
6. adequate bone-marrow, hepatic and renal function defined as laboratory tests within 7 days prior to enrollment:
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
C0022885 (UMLS CUI [4])
Hematology | Absolute neutrophil count | Platelet Count measurement
Item
1. haematology: absolute granulocytes > 1.5 x 109/l platelets > 100 x 109/l
boolean
C0200627 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Biochemistry finding | Serum bilirubin normal | Serum creatinine normal
Item
2. biochemistry:bilirubin within normal limits serum creatinine within normal limits
boolean
C0428132 (UMLS CUI [1])
C0428443 (UMLS CUI [2])
C0438244 (UMLS CUI [3])
Activated partial thromboplastin time normal | INR normal
Item
7. aptt and inr within normal limits within 7 days prior to enrollment.
boolean
C0853632 (UMLS CUI [1])
C0580416 (UMLS CUI [2])
Cardiac function | Left ventricular ejection fraction Normal Echocardiography | Left ventricular ejection fraction Normal MUGA scan
Item
8. adequate cardiac function with left ventricular ejection fraction (lvef) within normal limits determined by echocardiogram or muga within 28 days prior to inclusion.
boolean
C0232164 (UMLS CUI [1])
C0428772 (UMLS CUI [2,1])
C0205307 (UMLS CUI [2,2])
C0013516 (UMLS CUI [2,3])
C0428772 (UMLS CUI [3,1])
C0205307 (UMLS CUI [3,2])
C0521317 (UMLS CUI [3,3])
Informed Consent
Item
9. written informed consent must be given.
boolean
C0021430 (UMLS CUI [1])
Systemic therapy Secondary malignant neoplasm of female breast
Item
1. previous systemic treatment for mbc.
boolean
C1515119 (UMLS CUI [1,1])
C0346993 (UMLS CUI [1,2])
Major surgery
Item
2. major surgery less than 28 days prior to enrollment.
boolean
C0679637 (UMLS CUI [1])
Cancer Other | Exception Basal cell carcinoma Limited Controlled | Exception Squamous cell carcinoma of skin Limited Controlled | Exception Carcinoma in situ of uterine cervix Limited Controlled
Item
3. concurrent malignancy of any site, except adequately controlled limited basal cell carcinoma or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
C2587213 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C0439801 (UMLS CUI [3,3])
C2587213 (UMLS CUI [3,4])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C0439801 (UMLS CUI [4,3])
C2587213 (UMLS CUI [4,4])
Bleeding tendency | Thromboembolism | Warfarin | Heparin Analogs | Antiplatelet Agents
Item
4. bleeding diathesis, history of thromboembolic disease, or ongoing treatment with warfarin, heparin analogs or antiplatelet drugs.
boolean
C1458140 (UMLS CUI [1])
C0040038 (UMLS CUI [2])
C0043031 (UMLS CUI [3])
C0019134 (UMLS CUI [4,1])
C0243071 (UMLS CUI [4,2])
C0085826 (UMLS CUI [5])
Comorbidity cardiac major
Item
5. major cardiac comorbidity.
boolean
C0009488 (UMLS CUI [1,1])
C0018787 (UMLS CUI [1,2])
C0205164 (UMLS CUI [1,3])
Bevacizumab
Item
6. previous treatment with bevacizumab.
boolean
C0796392 (UMLS CUI [1])
Allergic Reaction Taxane Analogs
Item
7. previous allergic reaction to taxane analogs.
boolean
C1527304 (UMLS CUI [1,1])
C0215136 (UMLS CUI [1,2])
C0243071 (UMLS CUI [1,3])
Pregnancy | Breast Feeding
Item
8. ongoing pregnancy or lactation.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Mental condition Interferes with Protocol Compliance | Mental condition Interferes with Follow-up | Factor Familial Interferes with Protocol Compliance | Factor Familial Interferes with Follow-up | Sociological Factors Interfere with Protocol Compliance | Sociological Factors Interfere with Follow-up | Geographic Factors Interfere with Protocol Compliance | Geographic Factors Interfere with Follow-up
Item
9. 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])
C3840291 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C3274571 (UMLS CUI [2,3])
C1521761 (UMLS CUI [3,1])
C0241888 (UMLS CUI [3,2])
C0521102 (UMLS CUI [3,3])
C0525058 (UMLS CUI [3,4])
C1521761 (UMLS CUI [4,1])
C0241888 (UMLS CUI [4,2])
C0521102 (UMLS CUI [4,3])
C3274571 (UMLS CUI [4,4])
C3850138 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C0525058 (UMLS CUI [5,3])
C3850138 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C3274571 (UMLS CUI [6,3])
C0017444 (UMLS CUI [7,1])
C0521102 (UMLS CUI [7,2])
C0525058 (UMLS CUI [7,3])
C0017444 (UMLS CUI [8,1])
C0521102 (UMLS CUI [8,2])
C3274571 (UMLS CUI [8,3])